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Completed

NCT Number: NCT03296293

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEEP at 5cmH2O

Other

Effect of PEEP at 5cmH2O on ICP

PEEP at 10cmH2O

Other

Effect of PEEP at 10cmH2O on ICP

PEEP at 15cmH2O

Other

Effect of PEEP at 15cmH2O on ICP

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hongpeng Li

Other

Registry information

Official study 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

Acronym: PEEP,ICP,CVP

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 28, 2017
Registry last updated
Oct 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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