Effects of Positive End-expiratory Pressure on Intracranial Pressure in Patients With Severe Traumatic Brain Injury (PEEP，ICP，CVP)

September 28, 2017 updated by: Hongpeng Li

Doctor of Department of Emergency and Critical Care Medicine, Zhoupu Hospital Affiliated With Shanghai University of Medicine and Health Sciences, Shanghai 201318, PR China

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Effect of PEEP at 5cmH2O on ICP
Other: PEEP at 10cmH2O
Effect of PEEP at 10cmH2O on ICP
Other: PEEP at 15cmH2O
Effect of PEEP at 15cmH2O on ICP
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
Effect of PEEP at 5cmH2O on ICP
Other: PEEP at 10cmH2O
Effect of PEEP at 10cmH2O on ICP
Other: PEEP at 15cmH2O
Effect of PEEP at 15cmH2O on ICP
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
Effect of PEEP at 5cmH2O on ICP
Other: PEEP at 10cmH2O
Effect of PEEP at 10cmH2O on ICP
Other: PEEP at 15cmH2O
Effect of PEEP at 15cmH2O on ICP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of positive end-expiratory pressure on intracranial pressure in patients with severe traumatic brain injury
Time Frame: up to 12 months
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.
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hongpeng Li

Investigators

  • Principal Investigator: Hongpeng Li, master, Department of Emergency and Critical Care Medicine, Zhoupu Hospital affiliated with Shanghai University of Medicine and Health Sciences, Shanghai 201318, PR China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

June 15, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

September 18, 2017

First Submitted That Met QC Criteria

September 22, 2017

First Posted (Actual)

September 28, 2017

Study Record Updates

Last Update Posted (Actual)

October 2, 2017

Last Update Submitted That Met QC Criteria

September 28, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZhoupuH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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