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

NCT ID: NCT03296293

Last Updated: 2017-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2017-08-01

Brief Summary

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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

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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

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Traumatic Brain Injury Mechanical Ventilation Complication

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

PEEP at 5cmH2O

Intervention Type OTHER

Effect of PEEP at 5cmH2O on ICP

PEEP at 10cmH2O

Intervention Type OTHER

Effect of PEEP at 10cmH2O on ICP

PEEP at 15cmH2O

Intervention Type OTHER

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

Group Type OTHER

PEEP at 5cmH2O

Intervention Type OTHER

Effect of PEEP at 5cmH2O on ICP

PEEP at 10cmH2O

Intervention Type OTHER

Effect of PEEP at 10cmH2O on ICP

PEEP at 15cmH2O

Intervention Type OTHER

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

Group Type OTHER

PEEP at 5cmH2O

Intervention Type OTHER

Effect of PEEP at 5cmH2O on ICP

PEEP at 10cmH2O

Intervention Type OTHER

Effect of PEEP at 10cmH2O on ICP

PEEP at 15cmH2O

Intervention Type OTHER

Effect of PEEP at 15cmH2O on ICP

Interventions

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PEEP at 5cmH2O

Effect of PEEP at 5cmH2O on ICP

Intervention Type OTHER

PEEP at 10cmH2O

Effect of PEEP at 10cmH2O on ICP

Intervention Type OTHER

PEEP at 15cmH2O

Effect of PEEP at 15cmH2O on ICP

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hongpeng Li

OTHER

Sponsor Role lead

Responsible Party

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Hongpeng Li

medicine master

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hongpeng Li, master

Role: PRINCIPAL_INVESTIGATOR

Department of Emergency and Critical Care Medicine, Zhoupu Hospital affiliated with Shanghai University of Medicine and Health Sciences, Shanghai 201318, PR China

References

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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.

Reference Type RESULT
PMID: 26307004 (View on PubMed)

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.

Reference Type RESULT
PMID: 16215394 (View on PubMed)

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.

Reference Type RESULT
PMID: 27848125 (View on PubMed)

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.

Reference Type RESULT
PMID: 6890165 (View on PubMed)

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.

Reference Type RESULT
PMID: 28286808 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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ZhoupuH

Identifier Type: -

Identifier Source: org_study_id