A Comparative Study of High and Low Tidal Volume in Preventing Hypoxemia in Patients With Mechanical Ventilation After Cervical Spinal Cord Injury
Peking University Third Hospital
1 other identifier
observational
50
1 country
1
Brief Summary
This study in order to best tidal volume mechanical ventilation in patients with cervical spinal cord injury (sci) as the research point, through higher low volume Settings to find the difference of two groups of patients to prevent the incidence of hypoxemia, to find suitable Settings, tidal volume in patients with lower mechanical ventilation in patients with cervical spinal cord injury (sci) the incidence of pulmonary complications, live less intensive care unit (ICU).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 3, 2021
CompletedFirst Submitted
Initial submission to the registry
June 29, 2021
CompletedFirst Posted
Study publicly available on registry
July 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedJuly 2, 2021
August 1, 2020
1.2 years
June 29, 2021
June 29, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
The incidence of hypoxemia
The oxygenation index is less than 300
during machinical ventilation
Study Arms (2)
High volume group
The tidal volume of the exposed group was 10ml/kg ideal body weight.
Low volume group
The tidal volume of the non-exposed group was 6ml/kg ideal body weight
Interventions
Thea High tidal volume of the exposed group was 10ml/kg ideal body weight
Eligibility Criteria
① Above the age of 18; ② Patients with cervical spinal cord injury requiring mechanical ventilation admitted to hospital.
You may qualify if:
- All critically ill adult patients with cervical spinal cord injury who require mechanical ventilation and informed consent to be admitted to the Department of Critical Care Medicine of Peking University Third Hospital were selected by the subjects or their close relatives to enter the clinical study.
You may not qualify if:
- previous chronic obstructive pulmonary disease, diagnosis of acute respiratory distress syndrome at admission, presence of pneumothorax at admission, subjects or close relatives who refused to participate in the study, and non-signed informed consent."
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xuelei
Beijing, Beijing Municipality, 100191, China
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2021
First Posted
July 2, 2021
Study Start
April 3, 2021
Primary Completion
May 31, 2022
Study Completion
December 31, 2022
Last Updated
July 2, 2021
Record last verified: 2020-08