Comparison of Physiological Effects of Two Types of High-Flow Oxygen Therapy in Tracheostomized Patients

February 6, 2025 updated by: Jian-Xin Zhou

Comparison of Physiological Effects of Standard and Modified High-Flow Oxygen Therapy in Tracheostomized Patients

High-flow nasal oxygen therapy offers benefits like precise oxygen delivery, flow-related positive end-expiratory pressure generation and improved lung function. High-flow oxygen therapy can be applied via tracheostomy as high-flow tracheal oxygen. While high-flow tracheal oxygen has been used to facilitate weaning, it has diminished physiological effects due to bypassing upper airways. To enhance its effectiveness, researchers developed a modified high-flow tracheal oxygen tube with a smaller expiratory end diameter to increase airway resistance and pressure. This is a prospective randomized crossover study that aims to compare the physiological effects of standard and modified high-flow oxygen therapy in tracheostomized patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

High-flow nasal oxygen therapy has been shown to provide several physiological benefits, including precise control of the fraction of inspired oxygen, generation of flow-related positive end-expiratory pressure, increased end-expiratory lung volume, improved oxygenation, and enhanced carbon dioxide elimination. It has been widely utilized in managing acute hypoxemic respiratory failure and preventing hypoxemia after extubation.

High-flow oxygen therapy can be applied via tracheostomy as high-flow tracheal oxygen. Previous studies have reported successful cases of using high-flow tracheal oxygen to facilitate weaning from prolonged mechanical ventilation in patients with restrictive and obstructive pulmonary disorders. However, compared to high-flow nasal oxygen, high-flow tracheal oxygen exhibits significantly diminished physiological effects due to the bypassing of the narrow nasopharynx, glottis, and upper airway, as well as a more open circuit.

To address this limitation, the investigators have developed a modified high-flow tracheal oxygen tube with a reduced expiratory end tube diameter. This modification aims to create higher expiratory resistance and airway pressure, thus simulating the physiological effects of high-flow nasal cannula. This is a prospective randomized crossover physiological trial designed to compare the effects of standard and modified high-flow oxygen therapy in tracheostomized patients. Key physiological parameters will be assessed, including airway pressure, end-expiratory lung volume, vital signs, oxygenation, and respiratory workload.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100038
        • Beijing Shijitan Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Tracheostomy with stable spontaneous breathing.

Exclusion Criteria:

  1. Age younger than 18 years old
  2. Pregnancy
  3. Hemodynamic instability (mean arterial pressure <60 mmHg, heart rate >140 or <60 bpm)
  4. Respiratory and oxygenation instability (respiratory rate > 35bpm or oxygen saturation measured by pulse oximetry <90%)
  5. Neuromuscular diseases or phrenic nerve injury
  6. Recent trauma or surgery to the trachea, esophagus, neck, chest, or stomach
  7. Pneumothorax or placement of a chest drainage
  8. Contraindication to electrical impedance tomography (EIT) (implantable defibrillator)
  9. Anticipating withdrawal of life support

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Modified high flow tracheal oxygen
Modified high-flow tracheal oxygen with flow rates of 40L/ min and 60L/min will be performed in tracheostomized patients.
Procedure: Modified high flow tracheal oxygen
Modified high-flow tracheal oxygen with flow rates of 40L/min and 60L/min will be performed.
Experimental: Standard high flow tracheal oxygen
Standard high-flow tracheal oxygen with flow rates of 40 L/min and 60 L/min will be performed in tracheostomized patients.
Procedure: Standard high flow tracheal oxygen
Standard high-flow tracheal oxygen with flow rates of 40 L/min and 60 L/min will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean expiratory airway pressure
Time Frame: From enrollment to the end of treatment at 4 hours
Mean expiratory airway pressure will be measured during standard and modified high-flow tracheal oxygen.
From enrollment to the end of treatment at 4 hours
Positive end-expiratory pressure
Time Frame: From enrollment to the end of treatment at 4 hours
Positive end-expiratory pressure will be measured during standard and modified high-flow tracheal oxygen.
From enrollment to the end of treatment at 4 hours
Change of end-expiatory lung volume
Time Frame: From enrollment to the end of treatment at 4 hours
Change of end-expiatory lung volume will be measured during standard and modified high-flow tracheal oxygen.
From enrollment to the end of treatment at 4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory rate
Time Frame: From enrollment to the end of treatment at 4 hours
Respiratory rate will be measured during standard and modified high-flow tracheal oxygen.
From enrollment to the end of treatment at 4 hours
Tidal volume
Time Frame: From enrollment to the end of treatment at 4 hours
Tidal volume will be measured during standard and modified high-flow tracheal oxygen.
From enrollment to the end of treatment at 4 hours
End-tidal carbon dioxide
Time Frame: From enrollment to the end of treatment at 4 hours
End-tidal carbon dioxide will be measured during standard and modified high-flow tracheal oxygen.
From enrollment to the end of treatment at 4 hours
Pulse oxygen saturation
Time Frame: From enrollment to the end of treatment at 4 hours
Pulse oxygen saturation will be measured during standard and modified high-flow tracheal oxygen.
From enrollment to the end of treatment at 4 hours
Esophageal pressure-time product
Time Frame: From enrollment to the end of treatment at 4 hours
Esophageal pressure-time product will be measured during standard and modified high-flow tracheal oxygen.
From enrollment to the end of treatment at 4 hours
Tidal swing of esophageal pressure
Time Frame: From enrollment to the end of treatment at 4 hours
Tidal swing of esophageal pressure will be measured during standard and modified high-flow tracheal oxygen.
From enrollment to the end of treatment at 4 hours
Respiratory muscle pressure
Time Frame: From enrollment to the end of treatment at 4 hours
Respiratory muscle pressure will be measured during standard and modified high-flow tracheal oxygen.
From enrollment to the end of treatment at 4 hours
Dynamic transpulmonary pressure
Time Frame: From enrollment to the end of treatment at 4 hours
Dynamic transpulmonary pressure will be measured during standard and modified high-flow tracheal oxygen.
From enrollment to the end of treatment at 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jian-Xin Zhou

Investigators

  • Principal Investigator: Jian-Xin Zhou, MD, PhD, Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 20, 2025

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

February 4, 2025

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 6, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IIT2024-158-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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