Practice of Mechanical Ventilation in Patients With Severe Brain Injury in China

Respiration, Artificial Clinical Trial

Official title:

A Survey on the Practice of Mechanical Ventilation Among Patients With Severe Brain Injury in China: a Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02517073
• Other study ID #: MCS-2015-008
• Status: Completed
• Phase: N/A
• First received: August 4, 2015
• Last updated: January 26, 2016
• Start date: August 2015
• Est. completion date: September 2015

Study information

• Verified date: January 2016
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial Summary

The mechanical ventilation strategy has changed over years worldwide. Several international researches have been conducted to study the association of the use of mechanical ventilation with clinical outcomes. In this prospective, multicenter, cross-sectional survey, the practice of mechanical ventilation among patients with severe brain injury will be investigated in 70 intensive care units in China.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. older than 18 years

2. with severe brain injury (including severe traumatic brain injury, ischemic stroke, subarachnoid hemorrhage, spontaneous intracerebral hemorrhage, hypoxic-ischemic encephalopathy, intracranial tumor, intracranial infection and idiopathic epilepsy)

3. mechanical ventilated for at least 24 hours before the time of on-spot survey

Exclusion Criteria:

1. undergoing a spontaneous breathing trial (SBT) at the time of on-spot survey

2. underwent at least once SBT in the preceding 24 hours before time of on-spot survey

3. enrolled in another trial

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Brain Injuries
• Respiration, Artificial

Locations

Country	Name	City	State
China	ICU, Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients receiving control and assist mode of mechanical ventilation	Control mode is defined as volume or pressure control ventilation. Assist mode is defined as synchronized intermittent mandatory ventilation and pressure support ventilation.	During 1 hour of on-spot survey	No
Secondary	The settings of tidal volume, inspiratory pressure, and positive end-expiratory pressure in enrolled patients		During 1 hour of on-spot survey	No
Secondary	Duration of mechanical ventilation		60 days after on-spot survey	No
Secondary	Number of patients liberated from mechanical ventilation		60 days after on-spot survey	No
Secondary	Neurological outcome by Glasgow Outcome Scale		60 days after on-spot survey	No