High-flow Nasal Cannula Oxygen Therapy With the Chest Trauma Patients

February 5, 2018 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
This prospective randomized controlled study was conducted in the emergency intensive care units (EICU) of the second affiliated hospital Zhejiang university school of medicine, a large tertiary university hospital in HangZhou, China.The aim of this randomized study was to compare the effectiveness of high-flow nasal cannula with conventional oxygen therapy in ICU patients with blunt thoracic injury.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This prospective randomized controlled study was conducted in the emergency intensive care units (EICU) of the second affiliated hospital Zhejiang university school of medicine, a large tertiary university hospital in HangZhou, China.The aim of this randomized study was to compare the effectiveness of high-flow nasal cannula with conventional oxygen therapy in ICU patients with blunt thoracic injury.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

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

Description

Inclusion Criteria:

- The trauma registry was used to identify patients with moderate to severe blunt thoracic injury (abbreviated injury scale (AIS) chest score ≥3) admitted to the ICU

Exclusion Criteria:

  1. had intubation and used the mechanical ventilation within 2 hours
  2. had the emergency surgerys within 2 hours
  3. patients can not accessed by transthoracic lung ultrasound because of the sever aerodermectasia or pneumothorax
  4. the Glasgow Coma Scale <8

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: conventional oxygen therapy
oxygen was delivered by a nasal cannula or nonrebreather mask
Device: Conventional oxygen therapy
Conventional oxygen therapy
Active Comparator: High-flow Nasal Cannula Oxygen Therapy
Device: high-flow nasal cannula
high flow of air with supplemental oxygen was delivered by an Optiflow cannula interface using an AIRVO 2 blower humidifier

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
compare the effectiveness of high-flow nasal cannula with conventional oxygen therapy in ICU patients with blunt thoracic injury.
Time Frame: 72 hours
High-flow nasal cannula could reduce the intube rate of patients with blunt thoracic injury,and improve the the lung aeration for patients with thoracic injury
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of days in ICU
Time Frame: 7 days
High-flow nasal cannula could reduce the number of days for the patients treatments in ICU
7 days

Collaborators and Investigators

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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

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 (Anticipated)

March 1, 2018

Primary Completion (Anticipated)

March 30, 2019

Study Completion (Anticipated)

March 30, 2019

Study Registration Dates

First Submitted

January 4, 2018

First Submitted That Met QC Criteria

February 5, 2018

First Posted (Actual)

February 12, 2018

Study Record Updates

Last Update Posted (Actual)

February 12, 2018

Last Update Submitted That Met QC Criteria

February 5, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19850703

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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