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

NCT03296293 | Completed

• 1 other identifier: ZhoupuH
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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)

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 12 months

Study Arms (3)

Group I:IVPD≤3mmHg

OTHER

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; Other: PEEP at 10cmH2O; Other: PEEP at 15cmH2O

Group II:3mmHg<IVPD≤6mmHg

OTHER

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; Other: PEEP at 10cmH2O; Other: PEEP at 15cmH2O

Group III:IVPD>6mmHg

OTHER

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; Other: PEEP at 10cmH2O; Other: PEEP at 15cmH2O

Interventions

PEEP at 5cmH2O OTHER

Effect of PEEP at 5cmH2O on ICP

Group I:IVPD≤3mmHg; Group II:3mmHg<IVPD≤6mmHg; Group III:IVPD>6mmHg

PEEP at 10cmH2O OTHER

Effect of PEEP at 10cmH2O on ICP

Group I:IVPD≤3mmHg; Group II:3mmHg<IVPD≤6mmHg; Group III:IVPD>6mmHg

PEEP at 15cmH2O OTHER

Effect of PEEP at 15cmH2O on ICP

Group I:IVPD≤3mmHg; Group II:3mmHg<IVPD≤6mmHg; Group III:IVPD>6mmHg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients diagnosed with sTBI (GCS≤8) and applied with MV were initially included.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hongpeng Li: lead

Related Publications (5)

• 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.

  PMID: 26307004 RESULT

• 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.

  PMID: 16215394 RESULT

• 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.

  PMID: 27848125 RESULT

• 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.

  PMID: 6890165 RESULT

• 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.

  PMID: 28286808 RESULT

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: medicine master

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 28, 2017
• Study Start: August 1, 2016
• Primary Completion: June 15, 2017
• Study Completion: August 1, 2017
• Last Updated: October 2, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share