NCT03430258

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Status
unknown

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

First Submitted

Initial submission to the registry

January 4, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
Last Updated

February 12, 2018

Status Verified

January 1, 2018

Enrollment Period

1.1 years

First QC Date

January 4, 2018

Last Update Submit

February 5, 2018

Conditions

Blunt Thoracic InjuryLung Ultrasound Score

Outcome Measures

Primary Outcomes (1)

  • compare the effectiveness of high-flow nasal cannula with conventional oxygen therapy in ICU patients with blunt thoracic injury.

    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 Outcomes (1)

  • number of days in ICU

    7 days

Study Arms (2)

conventional oxygen therapy

PLACEBO COMPARATOR

oxygen was delivered by a nasal cannula or nonrebreather mask

Device: Conventional oxygen therapy

High-flow Nasal Cannula Oxygen Therapy

ACTIVE COMPARATOR

High-flow Nasal Cannula Oxygen Therapy

Device: high-flow nasal cannula

Interventions

high-flow nasal cannulaDEVICE

high flow of air with supplemental oxygen was delivered by an Optiflow cannula interface using an AIRVO 2 blower humidifier

High-flow Nasal Cannula Oxygen Therapy
Conventional oxygen therapyDEVICE

Conventional oxygen therapy

conventional oxygen therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2018

First Posted

February 12, 2018

Study Start

March 1, 2018

Primary Completion

March 30, 2019

Study Completion

March 30, 2019

Last Updated

February 12, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share