Correlation of Peak Tidal Inspiratory Flow Measured Before and After Extubation in Adult Patients With Hypoxemia

Sponsor
Rush University Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04971148
Collaborator
Hospital Vall d'Hebron (Other)
28
2
4
7.8
14
1.8

Study Details

Study Description

Brief Summary

In this study, patients who are ready for extubation and indicated for high-flow nasal cannula therapy after extubation will be enrolled, the investigators would measure the patient peak tidal inspiratory flow (PTIF) pre and post extubation to explore the correlation between the two PTIFs. Moreover, different HFNC flows would be applied, to explore the patient response in terms of oxygenation and lung aeration to different flow ratios that matched and are above post-extubation PTIF.

Condition or Disease Intervention/Treatment Phase
  • Other: HFNC flow set at patient peak tidal inspiratory flow
  • Other: HFNC flow set at 1.33 times of patient peak tidal inspiratory flow
  • Other: HFNC flow set at 1.67 times of patient peak tidal inspiratory flow
  • Other: HFNC flow set at 2 times of patient peak tidal inspiratory flow
N/A

Detailed Description

High-flow nasal cannula (HFNC) oxygen therapy has been shown to improve oxygenation, reduce the need for intubation for patients with acute hypoxemic respiratory failure (AHRF) and avoid reintubation for post-extubation patients who had high-risk factors. HFNC refers to the delivery of gas at flows that exceed the patient peak inspiratory flow during tidal breathing, However, patient peak tidal inspiratory flow (PTIF) is found to vary greatly among different patients, from 20 to 50 L/min, making it difficult to properly set HFNC in a way to achieve the desired effects. In two recently published studies in intubated patients, PTIF varied from 25-65 L/min or 40-80 L/min, thus this study aims to investigate the correlation between pre-extubation PTIF in different modalities of SBT and post-extubation PTIF for adult patients, who are indicated to use HFNC immediately after extubation. In addition, the investigators aim to explore the patient response in terms of oxygenation and lung aeration to different flow ratios that matched and are above post-extubation PTIF.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Patients will be randomized to receive different HFNC flow settings (matching their peak tidal inspiratory flow [PTIF], 1.33 times of PTIF, 1.67 times of PTIF and 2 times of PTIF)Patients will be randomized to receive different HFNC flow settings (matching their peak tidal inspiratory flow [PTIF], 1.33 times of PTIF, 1.67 times of PTIF and 2 times of PTIF)
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Correlation of Peak Tidal Inspiratory Flow Measured Before and After Extubation in Adult Patients With Hypoxemia, and Patients' Responses to Different Flows Above Their Peak Tidal Inspiratory Flow During High Flow Nasal Cannula Therapy
Actual Study Start Date :
Apr 7, 2022
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: HFNC flow set at patient peak tidal inspiratory flow

HFNC flow will be set at the level that matches patient peak tidal inspiratory flow

Other: HFNC flow set at patient peak tidal inspiratory flow
HFNC flow will be set at the level equal to patient peak tidal inspiratory flow

Experimental: HFNC flow set at 1.33 times of patient peak tidal inspiratory flow

HFNC flow will be set at the level that is 1.33 times of patient peak tidal inspiratory flow

Other: HFNC flow set at 1.33 times of patient peak tidal inspiratory flow
HFNC flow will be set at 1.33 times of patient peak tidal inspiratory flow

Experimental: HFNC flow set at 1.67 times of patient peak tidal inspiratory flow

HFNC flow will be set at the level that is 1.67 times of patient peak tidal inspiratory flow

Other: HFNC flow set at 1.67 times of patient peak tidal inspiratory flow
HFNC flow will be set at 1.67 times of patient peak tidal inspiratory flow

Experimental: HFNC flow set at 2 times of patient peak tidal inspiratory flow

HFNC flow will be set at the level that is 2 times of patient peak tidal inspiratory flow

Other: HFNC flow set at 2 times of patient peak tidal inspiratory flow
HFNC flow will be set 2 times of patient peak tidal inspiratory flow

Outcome Measures

Primary Outcome Measures

  1. SpO2/FIO2 [20 minutes after each flow setting]

    Twenty mins after each flow setting, pulse oximetry divided by fraction of inspired oxygen will be used to assess patient's oxygenation response to different flow

Secondary Outcome Measures

  1. End-expiratory lung volume assessed by EIT [20 minutes after each flow setting]

    Twenty mins after each flow setting, electrical impedance tomography (EIT) will be used to assess patient's end -expiratory lung volume 20 mins after each flow setting

  2. self-evaluated comfort [20 minutes after each flow setting]

    Twenty mins after each flow setting, patient comfort will be assessed using a visual numerical scale with a score of 0 as the worst and 10 as the best comfort

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adult intubated patients aged between 18 to 90 years

  • Pass spontaneous breathing trial and receive the order to be extubated

  • Have at least one of the indications to use HFNC after extubation

Exclusion Criteria:
  • Need to use inhaled epoprostenol via HFNC

  • Pregnant

  • Unable to use resuscitation mask, such as facial trauma, claustrophobia

  • Non-English speaker

  • Inability to verbally communicate

  • Using extracorporeal membrane oxygenation (ECMO)

  • Hemodynamically unstable

  • Difficult airway

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rush university medical center Chicago Illinois United States 60612
2 Hospital Universitari Vall d'Hebron Barcelona Spain

Sponsors and Collaborators

  • Rush University Medical Center
  • Hospital Vall d'Hebron

Investigators

  • Principal Investigator: Jie Li, PhD, Rush University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT04971148
Other Study ID Numbers:
  • HFNC-Flow-004
First Posted:
Jul 21, 2021
Last Update Posted:
May 6, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rush University Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2022