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

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Traumatic Brain Injury, Mechanical Ventilation Complication

Intervention / Treatment
-----------------
* Other: PEEP at 5cmH2O
* Other: PEEP at 10cmH2O
* Other: PEEP at 15cmH2O


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group I:IVPD≤3mmHg<br>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<br>* Effect of PEEP at 5cmH2O on ICP<br>Other: PEEP at 10cmH2O<br>* Effect of PEEP at 10cmH2O on ICP<br>Other: PEEP at 15cmH2O<br>* Effect of PEEP at 15cmH2O on ICP<br>|
| Other: Group II:3mmHg<IVPD≤6mmHg<br>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<br>* Effect of PEEP at 5cmH2O on ICP<br>Other: PEEP at 10cmH2O<br>* Effect of PEEP at 10cmH2O on ICP<br>Other: PEEP at 15cmH2O<br>* Effect of PEEP at 15cmH2O on ICP<br>|
| Other: Group III:IVPD>6mmHg<br>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<br>* Effect of PEEP at 5cmH2O on ICP<br>Other: PEEP at 10cmH2O<br>* Effect of PEEP at 10cmH2O on ICP<br>Other: PEEP at 15cmH2O<br>* Effect of PEEP at 15cmH2O on ICP<br>|

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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Positive end-expiratory pressure(PEEP), intracranial pressure(ICP), central venous pressure(CVP), intracranial central venous pressure difference(IVPD)