Clinical Trials Directory

Trials / Completed

CompletedNCT03296293

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
38 (actual)
Sponsor
Hongpeng Li · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERPEEP at 5cmH2OEffect of PEEP at 5cmH2O on ICP
OTHERPEEP at 10cmH2OEffect of PEEP at 10cmH2O on ICP
OTHERPEEP at 15cmH2OEffect of PEEP at 15cmH2O on ICP

Timeline

Start date
2016-08-01
Primary completion
2017-06-15
Completion
2017-08-01
First posted
2017-09-28
Last updated
2017-10-02

Source: ClinicalTrials.gov record NCT03296293. Inclusion in this directory is not an endorsement.