Physiological Effects of High-Flow Tracheal Oxygen Via An Modified Interface

Physiological Effects of High-Flow Tracheal Oxygen Via An Modified Interface in Tracheostomized Patients

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

Study Overview

• Status: Completed
• Conditions: Tracheostomy
• Intervention / Treatment: Procedure: The modified HFT

Detailed Description

Tracheostomy is often performed in patients after or anticipated prolonged mechanical ventilation, who are usually required oxygen therapy after discontinuation of mechanical ventilation.The high-flow tracheal (HFT) oxygen therapy in tracheostomized patients has been shown that can improve oxygenation,but can not induce positive end-expiratory pressure and elevation of end-expiratory lung volume. A modified HFT system by increasing expiratory resistance might induce PEEP and consequently elevate EELV.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Jian-Xin Zhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The tracheostomized patient

Description

Inclusion Criteria:

• The tracheostomized patient requiring the convenient oxygen therapy.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; The HFT was modified by increasing the expiratory resistance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in global and regional EELV	The Electrical impedance tomography (EIT) was applied in monitoring the change of EELV at the bedside.	the last 1 minutes of steady breathing during the standard or modified HFT.

Collaborators and Investigators

• Sponsor: Capital Medical University
• Investigators: Principal Investigator: Jian-Xin Zhou, MD, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): September 15, 2017
• Study Completion (Actual): February 5, 2018

Study Registration Dates

• First Submitted: August 7, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (Actual): August 10, 2017

Study Record Updates

• Last Update Posted (Actual): February 12, 2018
• Last Update Submitted That Met QC Criteria: February 9, 2018
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: high flow tracheal oxygen; modified interface
• Other Study ID Numbers: KY-2017-CC-13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No