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

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ClinicalTrials.gov Identifier: NCT03244761
Recruitment Status : Completed
First Posted : August 10, 2017
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Jian-Xin Zhou, Capital Medical University

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.

Condition or disease Intervention/treatment
Tracheostomy 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.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Physiological Effects of High-Flow Tracheal Oxygen Via An Modified Interface in Tracheostomized Patients
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : September 15, 2017
Actual Study Completion Date : February 5, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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.




Primary Outcome Measures :
  1. The mean end expiratory pressure. [ Time Frame: the last 1 minutes of steady breathing during the standard or modified HFT. ]
    The patients was delivering the high flow oxygen via the standard and modified HFT interface for 20 minutes.


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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The tracheostomized patient
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03244761


Locations
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China, Beijing
Jian-Xin Zhou
Beijing, Beijing, China, 100050
Sponsors and Collaborators
Capital Medical University
Investigators
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Principal Investigator: Jian-Xin Zhou, MD Beijing Tiantan Hospital

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Responsible Party: Jian-Xin Zhou, Professor, Capital Medical University
ClinicalTrials.gov Identifier: NCT03244761     History of Changes
Other Study ID Numbers: KY-2017-CC-13
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jian-Xin Zhou, Capital Medical University:
high flow tracheal oxygen
modified interface