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CompletedNCT03438383Updated Dec 16, 2020Results posted

Bi-PAP vs Sham Bi-PAP on Pulmonary Function in Morbidly Obese Patients After Bariatric Surgery

An interventional study of Bi-PAP and Sham Bi-PAP in Atelectasis, Pulmonary Infection and Chronic Obstructive Pulmonary Disease (COPD), sponsored by Evangelismos Hospital. Completed. Per ClinicalTrials.gov, last updated 2020-12-16.

Sponsored by Evangelismos Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Sex
All
01

Study summary

The effect of biphasic positive airway pressure (Bi-PAP) at individualized pressures on the postoperative pulmonary recovery of morbidly obese patients (MOP) undergoing open bariatric surgery (OBS) and possible placebo device-related effects (sham-Bi-PAP) were investigated.

Read the detailed description

In the present study the effect of Bi-PAP on the postoperative respiratory function and related complications of MOP undergoing OBS through a randomized sham-controlled design was investigated. Bi-PAP was applied at individualized pressures in order to optimize respiratory support and sham Bi-PAP was also used in order to neutralize possible placebo device related effect and researcher related bias.

The investigators hypothesized that the use of Bi-PAP at individualized pressures in MOP undergoing OBS, ameliorates postoperative respiratory function as well as diminishes related pulmonary complications, postoperative pain and duration of hospitalization. Primary endpoints were the difference in pre- and postoperative measurements of certain pulmonary function parameters (forced expiratory volume at one second (FEV1), forced vital capacity (FVC), peak expiratory flow rate (PEFR) and oxygen saturation by pulse oximetry (SpO2) and the incidence of certain pulmonary complications postoperatively (hypoxemia, atelectasis, lower respiratory tract infections). Secondary endpoints were postoperative pain and days of hospitalization.

02

Conditions studied

  • Atelectasis
  • Pulmonary Infection
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Pulmonary Disease
  • Hypoxemic Respiratory Failure
  • Hypoxemia
  • Morbid Obesity

Keywords

  • Bi-PAP
  • BiPAP
  • morbid obesity
  • anesthesia
  • bariatric surgery
  • sham Bi-PAP
  • sham BiPAP
  • postoperative complications
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All patients have been Morbidly Obese (BMI> 40kg/m2) for at least 10 years
  • All patients had unsuccessfully tried to lose weight by other non-invasive means.
  • All patients enrolled were continuous positive airway pressure (CPAP) and Bi-PAP naïve and had no knowledge about the Bi-PAP apparatus prior to enrollment
  • All patients underwent OBS (gastroplasty by Mason or gastric bypass) by the same operating team
  • All patients were treated with the same standard anesthetic protocol

Exclusion criteria

Exclusion Criteria:

  • Cardiovascular and pulmonary disease not related to obesity status
  • Chronic renal disease
  • Patients who were initially enrolled but did not use the allocated device (Bi-PAP or Sham Bi-PAP) for at least 12 h daily were also excluded at a later point.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Sham comparator
    Sham Bi-PAP

    Sham Bi-PAP was applied through nasal mask for 3 days postoperatively. Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of Bi-PAP. With this modality, also used on previous studies, the applied pressure by sham Bi-PAP was constant and equal to 2 centimeter of water (cm H2O).

    Device: Sham Bi-PAP

  • Active comparator
    Bi-PAP

    Bi-PAP through nasal mask, at individualized IPAP/EPAP pressures, was applied for 3 days postoperatively. IPAP and EPAP in the Bi-PAP system were individualized for each patient in accordance with accepted values of SpO2, PaCO2, and patient synchronization and tolerability with the device.Individualized setting of pressures in patient group was applied gradually starting with 12/4 cm H2O (IPAP/EPAP) and up to 18/10 (IPAP/EPAP) with consecutive increases of 2 cm H2O.

    Device: Bi-PAP

Interventions

  • DeviceBi-PAP

    The Bi-PAP system combines inspiratory support-IPAP (inspiratory positive airway pressure) with expiratory support-EPAP (expiratory positive airway pressure) and has been used, with good results, in a number of different clinical conditions such as COPD, respiratory failure due to neuromuscular disease, cardiogenic pulmonary edema and immediately post-operatively with pro-phylactic purpose.

  • DeviceSham Bi-PAP

    Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of the conventional Bi-PAP system. By doing so, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.

05

What researchers measure

Primary outcomes

  1. Forced Expiratory Volume at One Second (FEV1) Difference

    difference in FEV1 value measured by spirometry pre- and post-operatively

    Time frame: 24 h before surgery and at 24, 48 and 72 h post-operatively

  2. Forced Vital Capacity (FVC) Difference

    difference in FVC value measured by spirometry pre- and post-operatively

    Time frame: 24 h before surgery and at 24, 48 and 72 hours post-operatively

  3. Peak Expiratory Flow Rate (PEFR) Difference

    difference in PEFR value measured by spirometry pre- and post-operatively

    Time frame: 24 h before surgery and at 24, 48 and 72 hours post-operatively

  4. SpO2 Difference

    difference in SpO2 value measured by spirometry pre- and post-operatively

    Time frame: 24 h before surgery and at 24, 48 and 72 hours post-operatively

  5. Number of Participants With Hypoxemia

    occurrence of hypoxemia, considered as SpO2\<90%, post-operatively

    Time frame: At 24, 48 and 72 hours post-operatively

  6. Number of Participants With Atelectasis

    occurrence of atelectasis as defined by chest X-ray (CXR) post-operatively with CXR before surgery as baseline

    Time frame: At 24, 48 and 72 hours post-operatively

Secondary outcomes

  1. Post-operative Pain

    Intensity of pain was assessed post-operatively by Numerical Rating Scale (NRS) (0-10, 0=no pain, 10=worst pain imaginable)

    Time frame: right before spirometry, at 24, 48 and 72 h post-operatively

  2. Days of Hospitalization

    duration of hospitalization, calculated by discharge date minus admission date

    Time frame: From day of admission to day of discharge from the hospital

06

Results

Posted Mar 19, 2020
Limitations and caveats
The small sample size in both groups, although calculated to provide adequate statistical power; low tolerance of the Bi-PAP device, which led to the exclusion of some subjects from the study.

Participant flow

Τhis prospective randomized single-blinded study with a control group was conducted in a tertiary urban Greek hospital. Subjects recruitment was performed at the respective departments of obesity surgery where subjects underwent surgery, also belonging to tertiary hospitals.

Participant flow — Overall Study
MilestoneSham Bi-PAPBi-PAP
Started2324
Completed1421
Not completed93
Withdrew: Protocol violation93

Outcome measures

PrimaryForced Expiratory Volume at One Second (FEV1) Difference

difference in FEV1 value measured by spirometry pre- and post-operatively

Time frame:
24 h before surgery and at 24, 48 and 72 h post-operatively
Reported as:
Mean · Litres
Forced Expiratory Volume at One Second (FEV1) Difference
LitresSham Bi-PAPBi-PAP
24h before surgery3.1 ± 0.73.1 ± 0.6
24h post-op1.3 ± 0.51.4 ± 0.3
48h post-op1.3 ± 0.41.7 ± 0.4
72h post-op1.4 ± 0.51.9 ± 0.4
Statistical analysis
  • Sham Bi-PAP vs Bi-PAP · ANOVA · p = 0.88 (The a priori threshold for statistical significance was set at \<0.05)
  • Sham Bi-PAP vs Bi-PAP · ANOVA · p = 0.23 (The a priori threshold for statistical significance was set at \<0.05)
  • Sham Bi-PAP vs Bi-PAP · ANOVA · p = 0.008 (The a priori threshold for statistical significance was set at \<0.05)
  • Sham Bi-PAP vs Bi-PAP · ANOVA · p = 0.001 (The a priori threshold for statistical significance was set at \<0.05)
PrimaryForced Vital Capacity (FVC) Difference

difference in FVC value measured by spirometry pre- and post-operatively

Time frame:
24 h before surgery and at 24, 48 and 72 hours post-operatively
Reported as:
Mean · Litres
Forced Vital Capacity (FVC) Difference
LitresSham Bi-PAPBi-PAP
24h before surgery3.4 ± 1.03.5 ± 0.7
24h post-op1.3 ± 0.41.6 ± 0.4
48h post-op1.5 ± 0.52.0 ± 0.4
72h post-op1.9 ± 0.62.3 ± 0.4
Statistical analysis
  • Sham Bi-PAP vs Bi-PAP · ANOVA · p = 0.75 (The a priori threshold for statistical significance was set at \<0.05)
  • Sham Bi-PAP vs Bi-PAP · ANOVA · p = 0.09 (The a priori threshold for statistical significance was set at \<0.05)
  • Sham Bi-PAP vs Bi-PAP · ANOVA · p = 0.008 (The a priori threshold for statistical significance was set at \<0.05)
  • Sham Bi-PAP vs Bi-PAP · ANOVA · p = 0.013 (The a priori threshold for statistical significance was set at \<0.05)
PrimaryPeak Expiratory Flow Rate (PEFR) Difference

difference in PEFR value measured by spirometry pre- and post-operatively

Time frame:
24 h before surgery and at 24, 48 and 72 hours post-operatively
Reported as:
Mean · Litres/minute
Peak Expiratory Flow Rate (PEFR) Difference
Litres/minuteSham Bi-PAPBi-PAP
24h before surgery376.9 ± 71.7325.3 ± 75.2
24h post-op146.9 ± 61.4137.4 ± 30.5
48h post-op166.0 ± 68.1195.7 ± 46.0
72h post-op190.1 ± 64.2247.5 ± 60.5
Statistical analysis
  • Sham Bi-PAP vs Bi-PAP · ANOVA · p = 0.05 (The a priori threshold for statistical significance was set at \<0.05)
  • Sham Bi-PAP vs Bi-PAP · ANOVA · p = 0.55 (The a priori threshold for statistical significance was set at \<0.05)
  • Sham Bi-PAP vs Bi-PAP · ANOVA · p = 0.13 (The a priori threshold for statistical significance was set at \<0.05)
  • Sham Bi-PAP vs Bi-PAP · ANOVA · p = 0.011 (The a priori threshold for statistical significance was set at \<0.05)
PrimarySpO2 Difference

difference in SpO2 value measured by spirometry pre- and post-operatively

Time frame:
24 h before surgery and at 24, 48 and 72 hours post-operatively
Reported as:
Mean · percentage of SpO2
SpO2 Difference
percentage of SpO2Sham Bi-PAPBi-PAP
24h before surgery96.9 ± 0.796.9 ± 1.1
24h post-op91.6 ± 3.592.6 ± 3.2
48h post-op92.4 ± 3.595.2 ± 1.9
72h post-op92.5 ± 3.796.8 ± 1.0
Statistical analysis
  • Sham Bi-PAP vs Bi-PAP · ANOVA · p = 0.83 (The a priori threshold for statistical significance was set at \<0.05)
  • Sham Bi-PAP vs Bi-PAP · ANOVA · p = 0.37 (The a priori threshold for statistical significance was set at \<0.05)
  • Sham Bi-PAP vs Bi-PAP · ANOVA · p = 0.0035 (The a priori threshold for statistical significance was set at \<0.05)
  • Sham Bi-PAP vs Bi-PAP · ANOVA · p = 0.000015 (The a priori threshold for statistical significance was set at \<0.05)
PrimaryNumber of Participants With Hypoxemia

occurrence of hypoxemia, considered as SpO2\<90%, post-operatively

Time frame:
At 24, 48 and 72 hours post-operatively
Reported as:
Count of participants · Participants
Number of Participants With Hypoxemia
ParticipantsSham Bi-PAPBi-PAP
24h post-op50
48h post-op00
72h post-op00
PrimaryNumber of Participants With Atelectasis

occurrence of atelectasis as defined by chest X-ray (CXR) post-operatively with CXR before surgery as baseline

Time frame:
At 24, 48 and 72 hours post-operatively
Reported as:
Count of participants · Participants
Number of Participants With Atelectasis
ParticipantsSham Bi-PAPBi-PAP
24h post-op30
48h list-op30
72h post-op30
SecondaryPost-operative Pain

Intensity of pain was assessed post-operatively by Numerical Rating Scale (NRS) (0-10, 0=no pain, 10=worst pain imaginable)

Time frame:
right before spirometry, at 24, 48 and 72 h post-operatively
Reported as:
Mean · score on a scale
Post-operative Pain
score on a scaleSham Bi-PAPBi-PAP
24h post-op6.5 ± 1.96.5 ± 1.3
48h post-op4.5 ± 1.55.3 ± 1.9
72h post-op3.3 ± 1.23.5 ± 1.4
SecondaryDays of Hospitalization

duration of hospitalization, calculated by discharge date minus admission date

Time frame:
From day of admission to day of discharge from the hospital
Reported as:
Mean · days
Days of Hospitalization
daysSham Bi-PAPBi-PAP
Type of OBS: gastroplasty6 (5 to 7)6 (5 to 7)
Type of OBS: open gastric bypass10 (9 to 11)10 (9 to 11)

Adverse events

Collected over Up to 1 year after study completion.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Sham Bi-PAP0/14 (0%)0/14 (0%)0/14 (0%)
Bi-PAP0/21 (0%)0/21 (0%)0/21 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Sham Bi-PAPBi-PAPTotal
Mean33 ± 831 ± 631.8 ± 6.83
Sex: Female, Male
Sex: Female, Male(Participants)Sham Bi-PAPBi-PAPTotal
Female81321
Male6814
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Sham Bi-PAPBi-PAPTotal
Hispanic or Latino000
Not Hispanic or Latino142135
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Sham Bi-PAPBi-PAPTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White142135
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Sham Bi-PAPBi-PAPTotal
Greece142135
Height
Height(Centimeters)Sham Bi-PAPBi-PAPTotal
Mean171 ± 7172 ± 27171.6 ± 21.16
Weight
Weight(Kilograms)Sham Bi-PAPBi-PAPTotal
Mean151 ± 30157 ± 27154.6 ± 27.96
Body mass index-BMI
Body mass index-BMI(Kilograms/squared meters)Sham Bi-PAPBi-PAPTotal
Mean52 ± 653 ± 852.6 ± 7.19

3 further baseline measures are reported on the registry.

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Parameswaran K, Todd DC, Soth M. Altered respiratory physiology in obesity. Can Respir J. 2006 May-Jun;13(4):203-10. doi: 10.1155/2006/834786. PubMed 16779465 ↗
  • Salome CM, King GG, Berend N. Physiology of obesity and effects on lung function. J Appl Physiol (1985). 2010 Jan;108(1):206-11. doi: 10.1152/japplphysiol.00694.2009. Epub 2009 Oct 29. PubMed 19875713 ↗
  • Gifford AH, Leiter JC, Manning HL. Respiratory function in an obese patient with sleep-disordered breathing. Chest. 2010 Sep;138(3):704-15. doi: 10.1378/chest.09-3030. No abstract available. PubMed 20822992 ↗
  • Littleton SW. Impact of obesity on respiratory function. Respirology. 2012 Jan;17(1):43-9. doi: 10.1111/j.1440-1843.2011.02096.x. PubMed 22040049 ↗
  • Hans GA, Lauwick S, Kaba A, Brichant JF, Joris JL. Postoperative respiratory problems in morbidly obese patients. Acta Anaesthesiol Belg. 2009;60(3):169-75. PubMed 19961114 ↗
  • Lawrence VA, Dhanda R, Hilsenbeck SG, Page CP. Risk of pulmonary complications after elective abdominal surgery. Chest. 1996 Sep;110(3):744-50. doi: 10.1378/chest.110.3.744. PubMed 8797421 ↗
  • Simonneau G, Vivien A, Sartene R, Kunstlinger F, Samii K, Noviant Y, Duroux P. Diaphragm dysfunction induced by upper abdominal surgery. Role of postoperative pain. Am Rev Respir Dis. 1983 Nov;128(5):899-903. doi: 10.1164/arrd.1983.128.5.899. PubMed 6638679 ↗
  • Vassilakopoulos T, Mastora Z, Katsaounou P, Doukas G, Klimopoulos S, Roussos C, Zakynthinos S. Contribution of pain to inspiratory muscle dysfunction after upper abdominal surgery: A randomized controlled trial. Am J Respir Crit Care Med. 2000 Apr;161(4 Pt 1):1372-5. doi: 10.1164/ajrccm.161.4.9907082. PubMed 10764336 ↗
  • Pelosi P, Gregoretti C. Perioperative management of obese patients. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):211-25. doi: 10.1016/j.bpa.2010.02.001. PubMed 20608558 ↗
  • Loadsman JA, Hillman DR. Anaesthesia and sleep apnoea. Br J Anaesth. 2001 Feb;86(2):254-66. doi: 10.1093/bja/86.2.254. PubMed 11573670 ↗
  • Cullen A, Ferguson A. Perioperative management of the severely obese patient: a selective pathophysiological review. Can J Anaesth. 2012 Oct;59(10):974-96. doi: 10.1007/s12630-012-9760-2. Epub 2012 Jul 26. PubMed 22833138 ↗
  • Casati A, Putzu M. Anesthesia in the obese patient: pharmacokinetic considerations. J Clin Anesth. 2005 Mar;17(2):134-45. doi: 10.1016/j.jclinane.2004.01.009. PubMed 15809132 ↗
  • Kyzer S, Ramadan E, Gersch M, Chaimoff C. Patient-Controlled Analgesia Following Vertical Gastroplasty: a Comparison with Intramuscular Narcotics. Obes Surg. 1995 Feb;5(1):18-21. doi: 10.1381/096089295765558097. PubMed 10733789 ↗
  • Charghi R, Backman S, Christou N, Rouah F, Schricker T. Patient controlled i.v. analgesia is an acceptable pain management strategy in morbidly obese patients undergoing gastric bypass surgery. A retrospective comparison with epidural analgesia. Can J Anaesth. 2003 Aug-Sep;50(7):672-8. doi: 10.1007/BF03018709. PubMed 12944441 ↗
  • Nguyen NT, Lee SL, Goldman C, Fleming N, Arango A, McFall R, Wolfe BM. Comparison of pulmonary function and postoperative pain after laparoscopic versus open gastric bypass: a randomized trial. J Am Coll Surg. 2001 Apr;192(4):469-76; discussion 476-7. doi: 10.1016/s1072-7515(01)00822-5. PubMed 11294404 ↗
  • Thomas JA, McIntosh JM. Are incentive spirometry, intermittent positive pressure breathing, and deep breathing exercises effective in the prevention of postoperative pulmonary complications after upper abdominal surgery? A systematic overview and meta-analysis. Phys Ther. 1994 Jan;74(1):3-10; discussion 10-6. doi: 10.1093/ptj/74.1.3. PubMed 8265725 ↗
  • Ambrosino N, Gabbrielli L. Physiotherapy in the perioperative period. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):283-9. doi: 10.1016/j.bpa.2010.02.003. PubMed 20608563 ↗
  • Mehta S, Hill NS. Noninvasive ventilation. Am J Respir Crit Care Med. 2001 Feb;163(2):540-77. doi: 10.1164/ajrccm.163.2.9906116. No abstract available. PubMed 11179136 ↗
  • Pelosi P, Jaber S. Noninvasive respiratory support in the perioperative period. Curr Opin Anaesthesiol. 2010 Apr;23(2):233-8. doi: 10.1097/ACO.0b013e328335daec. PubMed 20019602 ↗
  • Renston JP, DiMarco AF, Supinski GS. Respiratory muscle rest using nasal BiPAP ventilation in patients with stable severe COPD. Chest. 1994 Apr;105(4):1053-60. doi: 10.1378/chest.105.4.1053. PubMed 8162724 ↗
  • Radunovic A, Annane D, Rafiq MK, Mustfa N. Mechanical ventilation for amyotrophic lateral sclerosis/motor neuron disease. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD004427. doi: 10.1002/14651858.CD004427.pub3. PubMed 23543531 ↗
  • Nava S, Carbone G, DiBattista N, Bellone A, Baiardi P, Cosentini R, Marenco M, Giostra F, Borasi G, Groff P. Noninvasive ventilation in cardiogenic pulmonary edema: a multicenter randomized trial. Am J Respir Crit Care Med. 2003 Dec 15;168(12):1432-7. doi: 10.1164/rccm.200211-1270OC. Epub 2003 Sep 4. PubMed 12958051 ↗
  • Moritz F, Brousse B, Gellee B, Chajara A, L'Her E, Hellot MF, Benichou J. Continuous positive airway pressure versus bilevel noninvasive ventilation in acute cardiogenic pulmonary edema: a randomized multicenter trial. Ann Emerg Med. 2007 Dec;50(6):666-75, 675.e1. doi: 10.1016/j.annemergmed.2007.06.488. Epub 2007 Aug 30. PubMed 17764785 ↗
  • Gust R, Gottschalk A, Schmidt H, Bottiger BW, Bohrer H, Martin E. Effects of continuous (CPAP) and bi-level positive airway pressure (BiPAP) on extravascular lung water after extubation of the trachea in patients following coronary artery bypass grafting. Intensive Care Med. 1996 Dec;22(12):1345-50. doi: 10.1007/BF01709549. PubMed 8986484 ↗
  • Aguilo R, Togores B, Pons S, Rubi M, Barbe F, Agusti AG. Noninvasive ventilatory support after lung resectional surgery. Chest. 1997 Jul;112(1):117-21. doi: 10.1378/chest.112.1.117. PubMed 9228366 ↗
  • Joris JL, Sottiaux TM, Chiche JD, Desaive CJ, Lamy ML. Effect of bi-level positive airway pressure (BiPAP) nasal ventilation on the postoperative pulmonary restrictive syndrome in obese patients undergoing gastroplasty. Chest. 1997 Mar;111(3):665-70. doi: 10.1378/chest.111.3.665. PubMed 9118706 ↗
  • Ebeo CT, Benotti PN, Byrd RP Jr, Elmaghraby Z, Lui J. The effect of bi-level positive airway pressure on postoperative pulmonary function following gastric surgery for obesity. Respir Med. 2002 Sep;96(9):672-6. doi: 10.1053/rmed.2002.1357. PubMed 12243311 ↗
  • Soroksky A, Stav D, Shpirer I. A pilot prospective, randomized, placebo-controlled trial of bilevel positive airway pressure in acute asthmatic attack. Chest. 2003 Apr;123(4):1018-25. doi: 10.1378/chest.123.4.1018. PubMed 12684289 ↗
  • Thys F, Roeseler J, Reynaert M, Liistro G, Rodenstein DO. Noninvasive ventilation for acute respiratory failure: a prospective randomised placebo-controlled trial. Eur Respir J. 2002 Sep;20(3):545-55. doi: 10.1183/09031936.02.00287402. PubMed 12358327 ↗
  • Crapo RO. Pulmonary-function testing. N Engl J Med. 1994 Jul 7;331(1):25-30. doi: 10.1056/NEJM199407073310107. No abstract available. PubMed 8202099 ↗
  • Lumb AB, Greenhill SJ, Simpson MP, Stewart J. Lung recruitment and positive airway pressure before extubation does not improve oxygenation in the post-anaesthesia care unit: a randomized clinical trial. Br J Anaesth. 2010 May;104(5):643-7. doi: 10.1093/bja/aeq080. Epub 2010 Mar 30. PubMed 20354010 ↗
  • Neligan PJ, Malhotra G, Fraser M, Williams N, Greenblatt EP, Cereda M, Ochroch EA. Continuous positive airway pressure via the Boussignac system immediately after extubation improves lung function in morbidly obese patients with obstructive sleep apnea undergoing laparoscopic bariatric surgery. Anesthesiology. 2009 Apr;110(4):878-84. doi: 10.1097/ALN.0b013e31819b5d8c. PubMed 19293693 ↗
  • Wong DT, Adly E, Ip HY, Thapar S, Maxted GR, Chung FF. A comparison between the Boussignac continuous positive airway pressure mask and the venturi mask in terms of improvement in the PaO2/F(I)O2 ratio in morbidly obese patients undergoing bariatric surgery: a randomized controlled trial. Can J Anaesth. 2011 Jun;58(6):532-9. doi: 10.1007/s12630-011-9497-3. Epub 2011 Apr 5. PubMed 21465320 ↗
  • Cobbold A, Lord S. Treatment and management of obesity: is surgical intervention the answer? J Perioper Pract. 2012 Apr;22(4):114-21. doi: 10.1177/175045891202200404. PubMed 22567762 ↗
  • Talab HF, Zabani IA, Abdelrahman HS, Bukhari WL, Mamoun I, Ashour MA, Sadeq BB, El Sayed SI. Intraoperative ventilatory strategies for prevention of pulmonary atelectasis in obese patients undergoing laparoscopic bariatric surgery. Anesth Analg. 2009 Nov;109(5):1511-6. doi: 10.1213/ANE.0b013e3181ba7945. PubMed 19843790 ↗
  • Eichenberger A, Proietti S, Wicky S, Frascarolo P, Suter M, Spahn DR, Magnusson L. Morbid obesity and postoperative pulmonary atelectasis: an underestimated problem. Anesth Analg. 2002 Dec;95(6):1788-92, table of contents. doi: 10.1097/00000539-200212000-00060. PubMed 12456460 ↗
  • Ramirez A, Lalor PF, Szomstein S, Rosenthal RJ. Continuous positive airway pressure in immediate postoperative period after laparoscopic Roux-en-Y gastric bypass: is it safe? Surg Obes Relat Dis. 2009 Sep-Oct;5(5):544-6. doi: 10.1016/j.soard.2009.05.007. Epub 2009 Jun 23. PubMed 19640798 ↗
  • Vasquez TL, Hoddinott K. A potential complication of bi-level positive airway pressure after gastric bypass surgery. Obes Surg. 2004 Feb;14(2):282-4. doi: 10.1381/096089204322857717. PubMed 15018761 ↗
  • Huerta S, DeShields S, Shpiner R, Li Z, Liu C, Sawicki M, Arteaga J, Livingston EH. Safety and efficacy of postoperative continuous positive airway pressure to prevent pulmonary complications after Roux-en-Y gastric bypass. J Gastrointest Surg. 2002 May-Jun;6(3):354-8. doi: 10.1016/s1091-255x(01)00048-8. PubMed 12022987 ↗
  • Alexandropoulou AN, Louis K, Papakonstantinou A, Tzirogiannis K, Stamataki E, Roussos C, Alchanatis M, Gratziou C, Vagiakis E, Roditis K. The influence of biphasic positive airway pressure vs. sham biphasic positive airway pressure on pulmonary function in morbidly obese patients after bariatric surgery. Anaesthesiol Intensive Ther. 2019;51(2):88-95. doi: 10.5114/ait.2019.85868. PubMed 31268268 ↗

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03438383
Lead sponsor
Evangelismos Hospital
Collaborators
Elpis General Hospital, Sotiria General Hospital, Evgenidion Hospital
Responsible party
Alexandropoulou N. Aikaterini (Consultant, Evangelismos Hospital) — Principal investigator
First posted
Feb 19, 2018
Start date
May 23, 2011
Primary completion
May 22, 2012
Completion
May 31, 2012
Results posted
Mar 19, 2020
Last update
Dec 16, 2020

Study contacts

Konstantinos Louis, MD, PhD
study director · Dpt of ObGyn, Konstantopoulio-Patision Hospital, Greece
Konstantinos Roditis, MD, MSc
study chair · Dpt of Vascular Surgery, Korgialenio-Benakio HRC Hospital, Greece
Aikaterini N. Alexandropoulou, MD, PhD
principal investigator · Anaesthesiology Dpt, Evangelismos Hospital, Greece

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
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