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CompletedNCT04723043Updated Oct 14, 2021

The Effect of Ventilation Modes on Cerebral Oxymetry In Operation

An interventional study of mechanical ventilation modes in Cholecystitis; Gallstone, Mechanical Ventilation Pressure High and Intraabdominal Hypertension, sponsored by Sisli Hamidiye Etfal Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-10-14.

Sponsored by Sisli Hamidiye Etfal Training and Research Hospital · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

In laparoscopic cholecystectomy method, Insufflation of CO2 in abdominal cavity causes positioning of the diaphragm upwards, a decrease in lung's volume and its compliance, an increase in the airway resistance, mismatch between the atelectasis and the ventilation perfusion. Although there are numerous studies in laparoscopic surgery, only a few of them investigate the effects of laparoscopic surgery on the cardiopulmonary and the respiratory mechanics. The investigator aimed To examine the effects of pressure-controlled and volume-controlled ventilation modes on cerebral oximetry and blood gases in laparoscopic cholecystectomy operations.

Read the detailed description

Since the laparoscopic methods have been introduced to the surgical operations, laparoscopic cholecystectomy has become the golden standard in gall bladder surgical treatments. In this method, carbon dioxide (CO2) pneumoperitoneum method is used to achieve the desired surgical and visual conditions. Alongside the advantages of the Laparoscopic cholecystectomy method (e.g. shortening the patient's length of stay at the hospital, minimal postoperative pain and rapid recovery), it has various intraabdominal pressure related systemic disadvantages . Insufflation of CO2 in abdominal cavity causes positioning of the diaphragm upwards, a decrease in lung's volume and its compliance, an increase in the airway resistance, mismatch between the atelectasis and the ventilation perfusion. Various ventilation strategies have been introduced to increase arterial oxygenation, functional residual capacity (FRC), and the lung compliance. Recent studies; demonstrates that pressure-controlled mechanical ventilation is superior to volume-controlled mechanical ventilation in providing arterial and tissue oxygenation.

Although there are numerous studies in laparoscopic surgery, only a few of them investigate the effects of laparoscopic surgery on the cardiopulmonary and the respiratory mechanics. Several experimental and clinical studies describe that the cardiovascular effects of the high intraabdominal pressure and the CO2 insufflation is complex. In fact, the results are linked to the studied patients' population, the lung's position and its volume. As it is known in laparoscopic surgeries, the oxygenation in cerebral tissue decreases as the intraabdominal pressure increases. At present, bispectral index (BIS), electroencephalography (EEG), auditory evoke potential (AEP) (and several others) and functional NIRS (fNIRS) are used to measure cerebral oxygenation and anaesthetic depth. NIRS monitorisation makes use of the combined effects of the transmission, the reflection, the dispersion, and the absorption of light. It can also measure the oxygen saturation in tissues that does not have pulsatile circulation. The investigator aimed To examine the effects of pressure-controlled and volume-controlled ventilation modes on cerebral oximetry and blood gases in laparoscopic cholecystectomy operations.

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Conditions studied

  • Cholecystitis; Gallstone
  • Mechanical Ventilation Pressure High
  • Intraabdominal Hypertension

Keywords

  • laparoscopy
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In context

Cholecystitis

272 studies on the registry are indexed under Cholecystitis; 46 are open to participants now.

This study's enrollment of 70 is below the median of 87 across 172 interventional studies indexed under Cholecystitis.

Browse Cholecystitis studies →

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital is the lead sponsor of 113 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ASA (American Society of Anesthesiology) score of 1 and 2
  • body mass index \< 30 kg/m2
  • planned elective laparoscopic cholecystectomy operation
  • 18-65 years old

Exclusion criteria

Exclusion Criteria:

  • who are applied with emergency laparoscopic cholecystectomy operation
  • ASA (American Society of Anesthesiology) score of 3 and above
  • hematocrit value 30 and below
  • body mass index> 30 kg/m2
  • major pulmonary disease (this condition was defined as having capacity and currency flow speed values that are below %70 in respiratory functional tests)
  • patients with a history of thoracic surgery
05

Study design

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

Study arms

  • Active comparator
    v group

    patients will ventilate with volume controlled mode

    Device: mechanical ventilation modes

  • Active comparator
    p group

    patients will ventilate with pressure controlled mode

    Device: mechanical ventilation modes

Interventions

  • Devicemechanical ventilation modes

    ventilation with pressure controlled mode in laparoscopic abdominal surgery ventilation with volume controlled mode in laparoscopic abdominal surgery

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What researchers measure

Primary outcomes

  1. NIRS

    near infrared reflectance spectroscopy values recorded at before the anesthesia, after intubation, before and after deflation

    Time frame: 0 to 3 hours (approximately)

  2. oxygen saturation

    oxygen saturation with pulse-oximeter at before the anesthesia, after intubation, before and after deflation

    Time frame: 0 to 3 hours (approximately)

  3. end-tidal carbon dioxide

    end-tidal carbon dioxide with mechanical ventilator at before the anesthesia, after intubation, before and after deflation

    Time frame: 0 to 3 hours (approximately)

Secondary outcomes

  1. partial oxygen pressure

    partial oxygen pressure in blood gases at before the anesthesia, after intubation, before and after deflation

    Time frame: 0 to 3 hours (approximately)

  2. P peak

    peak pressure in mechanical ventilation mod at before the anesthesia, after intubation, before and after deflation

    Time frame: 0 to 3 hours (approximately)

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Study locations

1 site
  • Sisli Etfal Research and Training Hospital
    Şişli, Istanbul 34371, Turkey (Türkiye)
08

References and documents

Publications

  • Gipson CL, Johnson GA, Fisher R, Stewart A, Giles G, Johnson JO, Tobias JD. Changes in cerebral oximetry during peritoneal insufflation for laparoscopic procedures. J Minim Access Surg. 2006 Jun;2(2):67-72. doi: 10.4103/0972-9941.26651. PubMed 21170237 ↗
  • Casati A, Fanelli G, Pietropaoli P, Proietti R, Tufano R, Danelli G, Fierro G, De Cosmo G, Servillo G; Collaborative Italian Study Group on Anesthesia in Elderly Patients. Continuous monitoring of cerebral oxygen saturation in elderly patients undergoing major abdominal surgery minimizes brain exposure to potential hypoxia. Anesth Analg. 2005 Sep;101(3):740-747. doi: 10.1213/01.ane.0000166974.96219.cd. PubMed 16115985 ↗
  • Nielsen HB. Systematic review of near-infrared spectroscopy determined cerebral oxygenation during non-cardiac surgery. Front Physiol. 2014 Mar 17;5:93. doi: 10.3389/fphys.2014.00093. eCollection 2014. PubMed 24672486 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04723043
Responsible party
Emre Badur MD (specialist medical doctor, Sisli Hamidiye Etfal Training and Research Hospital) — Principal investigator
First posted
Jan 25, 2021
Start date
Feb 1, 2021
Primary completion
Jun 1, 2021
Completion
Jun 25, 2021
Last update
Oct 14, 2021

Study contacts

ayse surhan cinar
study director · chief of anesthesia department

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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