Regional Ventilation During High Flow Nasal Cannula and Conventional Nasal Cannula in Patients With Hypoxia

October 23, 2016 updated by: Chae-Man Lim, Asan Medical Center

Comparison of Regional Ventilation Pattern During High Flow Nasal Cannula Between Conventional Low Flow System Nasal Cannula in Patients With Mild to Moderate Hypoxia

High-flow nasal cannula (HFNC) that uses heated and humidified oxygen was recently introduced for bedside care. It has been shown to be associated with reduced risks of tracheal intubation rates and mortality in adult hypoxic patients.

The mechanisms of the effects of HFNC are thought to be related to the favorable effects of the heated and humidified gas, the high-flow rate used to minimize the entrainment of room air, and an increase in the ventilation efficiency, including the elimination of nasopharyngeal dead space, positive end-expiratory pressure (PEEP) effects, and improvements in paradoxical abdominal movement. Regarding the effects on lung volume, global ventilation in the lungs increases during HFNC, which is thought to attribute to PEEP effects. However, how regional ventilation is affected during HFNC in comparison with conventional NC remains unknown.

Because PEEP in mechanically ventilated patients improves the regional homogeneity of ventilation, investigators postulated that HFNC via PEEP effects would result in more homogeneous regional distributions in the ventilation changes. Investigators therefore assessed global and regional ventilation in patients with hypoxia receiving care via HFNC using electric impedance tomography and compared these results with conventional nasal cannula.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >20 years
  • Subjective dyspnea in room air
  • SaO2< 90% in room air
  • Oxygen requirement for nasal cannula < 6 L/m

Exclusion Criteria:

  • Unstable vital signs

    • SBP <90 mmHg
    • DBP < 60 mmHg
    • Heart rate > 120 bpm
    • Respiratory rate > 30 bpm
    • Persistent dyspnea under oxygen therapy using NC

  • Severe hypoxia

    • PaO2/FiO2< 200 mmHg

  • Unable to cooperate

    • Delirium
    • Reduced cognitive function

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
Active Comparator: HFNC first
Patients in "HFNC first" receive oxygen therapy using HFNC in ahead of conventional nasal cannula oxygen therapy. After 20 minutes of HFNC therapy, patients receive conventional nasal cannula oxygen therapy.
Device: HFNC followed by conventional nasal cannula
Active Comparator: LFS first
Patients in "LFS first" receive oxygen therapy using conventional nasal cannula in ahead of HFNC therapy. After 20 minutes of conventional nasal cannula oxygen therapy, patients receive HFNC oxygen therapy.
Device: Conventional nasal cannula followed by HFNC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tidal variation
Time Frame: Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy)
Tidal variation using electric impedance tomography
Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen saturation
Time Frame: Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy)
Oxygen saturation at using pulse oxymeter
Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy)
Respiration Rate
Time Frame: Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy)
Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy)
Subjective comfort
Time Frame: Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy)
Subjective comfort using questionnaire
Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy)

Collaborators and Investigators

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

Sponsor

Asan Medical Center

Collaborators

Ministry of Trade, Industry & Energy, Republic of Korea

Investigators

  • Principal Investigator: Chae-Man Lim, MD, Pulmonary and Critical Care Medicine, Asan Medical Center, College of Medicine, University of Ulsan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

October 21, 2016

First Submitted That Met QC Criteria

October 23, 2016

First Posted (Estimate)

October 25, 2016

Study Record Updates

Last Update Posted (Estimate)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 23, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMNI

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.

Clinical Trials on Hypoxia

Clinical Trials on HFNC followed by conventional nasal cannula

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe