NCT03244761

Brief Summary

Tracheostomy is often performed in patients after or anticipated prolonged mechanical ventilation, who are usually required oxygen therapy after discontinuation of mechanical ventilation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 7, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 10, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2018

Completed
Last Updated

February 12, 2018

Status Verified

August 1, 2017

Enrollment Period

3 months

First QC Date

August 7, 2017

Last Update Submit

February 9, 2018

Conditions

Tracheostomy

Keywords

high flow tracheal oxygenmodified interface

Outcome Measures

Primary Outcomes (1)

  • The mean end expiratory pressure.

    The patients was delivering the high flow oxygen via the standard and modified HFT interface for 20 minutes.

    the last 1 minutes of steady breathing during the standard or modified HFT.

Secondary Outcomes (1)

  • Changes in global and regional EELV

    the last 1 minutes of steady breathing during the standard or modified HFT.

Study Arms (2)

The standard HFT

The high-flow oxygen was delivered via tracheostomy using a standard HFT.

The modified HFT

The high-flow oxygen was delivered via tracheostomy using a modified HFT.

Procedure: The modified HFT

Interventions

The modified HFTPROCEDURE

The HFT was modified by increasing the expiratory resistance.

The modified HFT

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The tracheostomized patient

You may qualify if:

  • The tracheostomized patient requiring the convenient oxygen therapy.

You may not qualify if:

  • Under 18 years;
  • history of esophageal, gastric or lung surgery;
  • The contraindication of using EIT (pacemaker, defibrillator, and implantable pumps).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jian-Xin Zhou

Beijing, Beijing Municipality, 100050, China

Location

Study Officials

  • Jian-Xin Zhou, MD

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 7, 2017

First Posted

August 10, 2017

Study Start

July 1, 2017

Primary Completion

September 15, 2017

Study Completion

February 5, 2018

Last Updated

February 12, 2018

Record last verified: 2017-08

Locations

CN(1)