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

Traumatic Brain Injury Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03296293
• Other study ID #: ZhoupuH
• Status: Completed
• Phase: N/A
• First received: September 18, 2017
• Last updated: September 28, 2017
• Start date: August 1, 2016
• Est. completion date: August 1, 2017

Study information

• Verified date: September 2017
• Source: Zhoupu Hospital, Pudong New Area, Shanghai, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 1, 2017
• Est. primary completion date: June 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Mechanical Ventilation Complication
• Traumatic Brain Injury

Intervention

Other:
• PEEP at 5cmH2O
Effect of PEEP at 5cmH2O on ICP
• PEEP at 10cmH2O
Effect of PEEP at 10cmH2O on ICP
• PEEP at 15cmH2O
Effect of PEEP at 15cmH2O on ICP

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hongpeng Li

References & Publications (5)

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 — View 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. — View Citation

Nemer SN, Caldeira JB, Santos RG, Guimarães 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 dist — View Citation

Ropper AH, O'Rourke D, Kennedy SK. Head position, intracranial pressure, and compliance. Neurology. 1982 Nov;32(11):1288-91. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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