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

Primary Purpose

Traumatic Brain Injury, Mechanical Ventilation Complication

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PEEP at 5cmH2O
PEEP at 10cmH2O
PEEP at 15cmH2O
Sponsored by
Hongpeng Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Traumatic Brain Injury focused on measuring Positive end-expiratory pressure(PEEP), intracranial pressure(ICP), central venous pressure(CVP), intracranial central venous pressure difference(IVPD)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Other

    Other

    Other

    Arm Label

    Group I:IVPD≤3mmHg

    Group II:3mmHg<IVPD≤6mmHg

    Group III:IVPD>6mmHg

    Arm Description

    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

    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

    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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 18, 2017
    Last Updated
    September 28, 2017
    Sponsor
    Hongpeng Li
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03296293
    Brief Title
    Effects of Positive End-expiratory Pressure on Intracranial Pressure in Patients With Severe Traumatic Brain Injury
    Acronym
    PEEP,ICP,CVP
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2016 (Actual)
    Primary Completion Date
    June 15, 2017 (Actual)
    Study Completion Date
    August 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Hongpeng Li

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Traumatic Brain Injury, Mechanical Ventilation Complication
    Keywords
    Positive end-expiratory pressure(PEEP), intracranial pressure(ICP), central venous pressure(CVP), intracranial central venous pressure difference(IVPD)

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    38 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group I:IVPD≤3mmHg
    Arm Type
    Other
    Arm Description
    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
    Arm Title
    Group II:3mmHg<IVPD≤6mmHg
    Arm Type
    Other
    Arm Description
    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
    Arm Title
    Group III:IVPD>6mmHg
    Arm Type
    Other
    Arm Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    PEEP at 5cmH2O
    Intervention Description
    Effect of PEEP at 5cmH2O on ICP
    Intervention Type
    Other
    Intervention Name(s)
    PEEP at 10cmH2O
    Intervention Description
    Effect of PEEP at 10cmH2O on ICP
    Intervention Type
    Other
    Intervention Name(s)
    PEEP at 15cmH2O
    Intervention Description
    Effect of PEEP at 15cmH2O on ICP
    Primary Outcome Measure Information:
    Title
    Effects of positive end-expiratory pressure on intracranial pressure in patients with severe traumatic brain injury
    Description
    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.
    Time Frame
    up to 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hongpeng Li, master
    Organizational Affiliation
    Department of Emergency and Critical Care Medicine, Zhoupu Hospital affiliated with Shanghai University of Medicine and Health Sciences, Shanghai 201318, PR China
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26307004
    Citation
    Nemer SN, Caldeira JB, Santos RG, Guimaraes BL, Garcia JM, Prado D, Silva RT, Azeredo LM, Faria ER, Souza PC. Effects of positive end-expiratory pressure on brain tissue oxygen pressure of severe traumatic brain injury patients with acute respiratory distress syndrome: A pilot study. J Crit Care. 2015 Dec;30(6):1263-6. doi: 10.1016/j.jcrc.2015.07.019. Epub 2015 Jul 26.
    Results Reference
    result
    PubMed Identifier
    16215394
    Citation
    Muench E, Bauhuf C, Roth H, Horn P, Phillips M, Marquetant N, Quintel M, Vajkoczy P. Effects of positive end-expiratory pressure on regional cerebral blood flow, intracranial pressure, and brain tissue oxygenation. Crit Care Med. 2005 Oct;33(10):2367-72. doi: 10.1097/01.ccm.0000181732.37319.df.
    Results Reference
    result
    PubMed Identifier
    27848125
    Citation
    Boone MD, Jinadasa SP, Mueller A, Shaefi S, Kasper EM, Hanafy KA, O'Gara BP, Talmor DS. The Effect of Positive End-Expiratory Pressure on Intracranial Pressure and Cerebral Hemodynamics. Neurocrit Care. 2017 Apr;26(2):174-181. doi: 10.1007/s12028-016-0328-9.
    Results Reference
    result
    PubMed Identifier
    6890165
    Citation
    Ropper AH, O'Rourke D, Kennedy SK. Head position, intracranial pressure, and compliance. Neurology. 1982 Nov;32(11):1288-91. doi: 10.1212/wnl.32.11.1288.
    Results Reference
    result
    PubMed Identifier
    28286808
    Citation
    Shojaee M, Sabzghabaei A, Alimohammadi H, Derakhshanfar H, Amini A, Esmailzadeh B. Effect of Positive End-Expiratory Pressure on Central Venous Pressure in Patients under Mechanical Ventilation. Emerg (Tehran). 2017;5(1):e1. Epub 2017 Jan 8.
    Results Reference
    result

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

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