CClinicalTrials.gg
CompletedNCT03296293PEEP,ICP,CVPUpdated Oct 2, 2017

Effects of Positive End-expiratory Pressure on Intracranial Pressure in Patients With Severe Traumatic Brain Injury

An interventional study of PEEP at 5cmH2O and PEEP at 10cmH2O in Traumatic Brain Injury and Mechanical Ventilation Complication, sponsored by Hongpeng Li. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-10-02.

Sponsored by Hongpeng Li · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The impact of PEEP on ICP was dependent on the difference between elevated CVP levels and baseline ICP levels. ICP would increase once elevated CVP through PEEP adjustment exceeds the baseline ICP.

Read the detailed description

all patients were exposed to incremental PEEP levels of 0, 5, 10, and 15cmH2O with 100% of FiO2. The measurements were done bedside on stabilized hemodynamics and intracranial pressure. The measurement was discontinued if the following situation presented and remedies were applied accordingly: (1) CPP \< 60 mmHg (norepinephrine at 0.3\~1.0μg/kg.min was used); (2) ICP > 25 mmHg (PEEP was restored to 0); (3) increase of pressure plateau > 35 cmH2O (tidal volume was decreased and PetCO2 was maintained at 30\~35mmHg); (4) SpO2 \< 90% (PEEP was restored to 0); and (5) suspicion of pneumothorax (PEEP was restored to 0 and chest radiography was performed). An equilibration period (at least 90 seconds) was entailed to ensure a normalized baseline PetCO2 through modulating tidal volume and respiratory rate.

ICP, CVP, Pj, and MAP were measured twice or more at each level of PEEP for consecutively five days after admission. CPP was calculated according to the following equation: CPP=MAP-ICP. The difference between baseline ICP and CVP was categorized into the following three groups according to the previous findings: Group I,IVPD ≤ 3mmHg, Group II, 3 \< IVPD ≤ 6 mmHg, Group III, IVPD > 6 mmHg. Relationships between PEEP and ICP, CVP and MAP, CVP and Pj were analyzed in each group respectively.

02

Conditions studied

  • Traumatic Brain Injury
  • Mechanical Ventilation Complication

Keywords

  • Positive end-expiratory pressure(PEEP)
  • intracranial pressure(ICP)
  • central venous pressure(CVP)
  • intracranial central venous pressure difference(IVPD)
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All patients diagnosed with sTBI (GCS≤8) and applied with MV were initially included.

Exclusion criteria

Exclusion Criteria:

  • Brain death
  • Younger than 18 or older than 80 years
  • Pregnancy
  • Hemodynamic instability:for example heart rate >120 bpm or CPP \<60 mmHg
  • Bulbous lung or pneumothorax
  • Myocardial infarction
  • Refusal of consent
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Other
    Group I:IVPD≤3mmHg

    Effect of PEEP at 5cmH2O on ICP in Group I:IVPD≤3mmHg Effect of PEEP at 10cmH2O on ICP in Group I:IVPD≤3mmHg Effect of PEEP at 15cmH2O on ICP in Group I:IVPD≤3mmHg

    Other: PEEP at 5cmH2O · Other: PEEP at 10cmH2O · Other: PEEP at 15cmH2O

  • Other
    Group II:3mmHg<IVPD≤6mmHg

    Effect of PEEP at 5cmH2O on ICP in Group II:3mmHg\<IVPD≤6mmHg Effect of PEEP at 10cmH2O on ICP in Group II:3mmHg\<IVPD≤6mmHg Effect of PEEP at 15cmH2O on ICP in Group II:3mmHg\<IVPD≤6mmHg

    Other: PEEP at 5cmH2O · Other: PEEP at 10cmH2O · Other: PEEP at 15cmH2O

  • Other
    Group III:IVPD>6mmHg

    Effect of PEEP at 5cmH2O on ICP in Group III:IVPD\>6mmHg Effect of PEEP at 10cmH2O on ICP in Group III:IVPD\>6mmHg Effect of PEEP at 15cmH2O on ICP in Group III:IVPD\>6mmHg

    Other: PEEP at 5cmH2O · Other: PEEP at 10cmH2O · Other: PEEP at 15cmH2O

Interventions

  • OtherPEEP at 5cmH2O

    Effect of PEEP at 5cmH2O on ICP

  • OtherPEEP at 10cmH2O

    Effect of PEEP at 10cmH2O on ICP

  • OtherPEEP at 15cmH2O

    Effect of PEEP at 15cmH2O on ICP

05

What researchers measure

Primary outcomes

  1. Effects of positive end-expiratory pressure on intracranial pressure in patients with severe traumatic brain injury

    The impact of PEEP on ICP was dependent on the difference between elevated CVP levels and baseline ICP levels. ICP would increase once elevated CVP through PEEP adjustment exceeds the baseline ICP.

    Time frame: up to 12 months

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Nemer SN, Caldeira JB, Santos RG, Guimaraes BL, Garcia JM, Prado D, Silva RT, Azeredo LM, Faria ER, Souza PC. Effects of positive end-expiratory pressure on brain tissue oxygen pressure of severe traumatic brain injury patients with acute respiratory distress syndrome: A pilot study. J Crit Care. 2015 Dec;30(6):1263-6. doi: 10.1016/j.jcrc.2015.07.019. Epub 2015 Jul 26. PubMed 26307004 ↗
  • Muench E, Bauhuf C, Roth H, Horn P, Phillips M, Marquetant N, Quintel M, Vajkoczy P. Effects of positive end-expiratory pressure on regional cerebral blood flow, intracranial pressure, and brain tissue oxygenation. Crit Care Med. 2005 Oct;33(10):2367-72. doi: 10.1097/01.ccm.0000181732.37319.df. PubMed 16215394 ↗
  • Boone MD, Jinadasa SP, Mueller A, Shaefi S, Kasper EM, Hanafy KA, O'Gara BP, Talmor DS. The Effect of Positive End-Expiratory Pressure on Intracranial Pressure and Cerebral Hemodynamics. Neurocrit Care. 2017 Apr;26(2):174-181. doi: 10.1007/s12028-016-0328-9. PubMed 27848125 ↗
  • Ropper AH, O'Rourke D, Kennedy SK. Head position, intracranial pressure, and compliance. Neurology. 1982 Nov;32(11):1288-91. doi: 10.1212/wnl.32.11.1288. PubMed 6890165 ↗
  • Shojaee M, Sabzghabaei A, Alimohammadi H, Derakhshanfar H, Amini A, Esmailzadeh B. Effect of Positive End-Expiratory Pressure on Central Venous Pressure in Patients under Mechanical Ventilation. Emerg (Tehran). 2017;5(1):e1. Epub 2017 Jan 8. PubMed 28286808 ↗

Study documents

  • Protocol and statistical analysis plan · Dec 1, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03296293
Lead sponsor
Hongpeng Li
Responsible party
Hongpeng Li (medicine master, Zhoupu Hospital, Pudong New Area, Shanghai, China) — Sponsor-investigator
First posted
Sep 28, 2017
Start date
Aug 1, 2016
Primary completion
Jun 15, 2017
Completion
Aug 1, 2017
Last update
Oct 2, 2017

Study contacts

Hongpeng Li, master
principal investigator · Department of Emergency and Critical Care Medicine, Zhoupu Hospital affiliated with Shanghai University of Medicine and Health Sciences, Shanghai 201318, PR China

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 Sep 2017. You cannot join it, but the record below documents what was studied.

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