A Comparative Study of High and Low Tidal Volume in Preventing Hypoxemia in Patients With Mechanical Ventilation After Cervical Spinal Cord Injury

June 29, 2021 updated by: Peking University Third Hospital

Peking University Third Hospital

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Xuelei
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

① Above the age of 18;

② Patients with cervical spinal cord injury requiring mechanical ventilation admitted to hospital.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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."

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Thea High tidal volume of the exposed group was 10ml/kg ideal body weight
Other Names:
  • Low volume group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of hypoxemia
Time Frame: during machinical ventilation
The oxygenation index is less than 300
during machinical ventilation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2021

Primary Completion (Anticipated)

May 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

June 29, 2021

First Submitted That Met QC Criteria

June 29, 2021

First Posted (Actual)

July 2, 2021

Study Record Updates

Last Update Posted (Actual)

July 2, 2021

Last Update Submitted That Met QC Criteria

June 29, 2021

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LM2020353

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe