NCT06816745

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

February 4, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 10, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

February 20, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

February 10, 2025

Status Verified

February 1, 2025

Enrollment Period

9 months

First QC Date

February 4, 2025

Last Update Submit

February 6, 2025

Conditions

Critical CareOxygen TherapyTracheostomy

Keywords

high-flow tracheal oxygentracheostomy

Outcome Measures

Primary Outcomes (3)

  • Mean expiratory airway pressure

    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

    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

    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 Outcomes (8)

  • Respiratory rate

    From enrollment to the end of treatment at 4 hours

  • Tidal volume

    From enrollment to the end of treatment at 4 hours

  • End-tidal carbon dioxide

    From enrollment to the end of treatment at 4 hours

  • Pulse oxygen saturation

    From enrollment to the end of treatment at 4 hours

  • Esophageal pressure-time product

    From enrollment to the end of treatment at 4 hours

  • +3 more secondary outcomes

Study Arms (2)

Modified high flow tracheal oxygen

EXPERIMENTAL

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

Standard high flow tracheal oxygen

EXPERIMENTAL

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

Interventions

Modified high flow tracheal oxygenPROCEDURE

Modified high-flow tracheal oxygen with flow rates of 40L/min and 60L/min will be performed.

Modified high flow tracheal oxygen
Standard high flow tracheal oxygenPROCEDURE

Standard high-flow tracheal oxygen with flow rates of 40 L/min and 60 L/min will be performed.

Standard high flow tracheal oxygen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Tracheostomy with stable spontaneous breathing.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Shijitan Hospital

Beijing, Beijing Municipality, 100038, China

Location

Study Officials

  • Jian-Xin Zhou, MD, PhD

    Capital Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian-Xin Zhou, MD, PhD

CONTACT

8610 6392 6666zhoujx.cn@icloud.com

Shan-Shan Xu, MD

CONTACT

86185012191331004496285@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 4, 2025

First Posted

February 10, 2025

Study Start

February 20, 2025

Primary Completion

November 30, 2025

Study Completion

December 30, 2025

Last Updated

February 10, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)