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

Tracheostomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03244761
• Other study ID #: KY-2017-CC-13
• Status: Completed
• Phase: N/A
• First received: August 7, 2017
• Last updated: February 9, 2018
• Start date: July 1, 2017
• Est. completion date: February 5, 2018

Study information

• Verified date: August 2017
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 5, 2018
• Est. primary completion date: September 15, 2017
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Tracheostomy

Intervention

Procedure:
• The modified HFT
The HFT was modified by increasing the expiratory resistance.

Locations

Country	Name	City	State
China	Jian-Xin Zhou	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.