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

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ClinicalTrials.gov Identifier: NCT03296293
Recruitment Status : Completed
First Posted : September 28, 2017
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
Hongpeng Li, Zhoupu Hospital, Pudong New Area, Shanghai, China

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Mechanical Ventilation Complication Other: PEEP at 5cmH2O Other: PEEP at 10cmH2O Other: PEEP at 15cmH2O Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : August 1, 2016
Actual Primary Completion Date : June 15, 2017
Actual Study Completion Date : August 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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

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




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03296293


Sponsors and Collaborators
Hongpeng Li
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Hongpeng Li, Zhoupu Hospital, Pudong New Area, Shanghai, China:

Publications of Results:
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Responsible Party: Hongpeng Li, medicine master, Zhoupu Hospital, Pudong New Area, Shanghai, China
ClinicalTrials.gov Identifier: NCT03296293     History of Changes
Other Study ID Numbers: ZhoupuH
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hongpeng Li, Zhoupu Hospital, Pudong New Area, Shanghai, China:
Positive end-expiratory pressure(PEEP)
intracranial pressure(ICP)
central venous pressure(CVP)
intracranial central venous pressure difference(IVPD)

Additional relevant MeSH terms:
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Physiological Effects of Drugs
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Dihydrotachysterol
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents