NCT04949971

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

July 2, 2021

Status Verified

August 1, 2020

Enrollment Period

1.2 years

First QC Date

June 29, 2021

Last Update Submit

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

Behavioral: High volume group

Interventions

Thea High tidal volume of the exposed group was 10ml/kg ideal body weight

Also known as: Low volume group
Low volume group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

RECRUITING

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

Locations