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

Primary Purpose

Hypoxemic Respiratory Failure

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
HFNC flow set at patient peak tidal inspiratory flow
HFNC flow set at 1.33 times of patient peak tidal inspiratory flow
HFNC flow set at 1.67 times of patient peak tidal inspiratory flow
HFNC flow set at 2 times of patient peak tidal inspiratory flow
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoxemic Respiratory Failure focused on measuring high-flow nasal cannula, flow setting, peak tidal inspiratory flow, hypoxemia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rush university medical center
  • Hospital Universitari Vall d'Hebron

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

HFNC flow set at patient peak tidal inspiratory flow

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

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

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

Arm Description

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

HFNC flow will be set at the level that is 1.33 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

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

Outcomes

Primary Outcome Measures

SpO2/FIO2
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

End-expiratory lung volume assessed by EIT
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
self-evaluated comfort
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

Full Information

First Posted
July 12, 2021
Last Updated
August 8, 2023
Sponsor
Rush University Medical Center
Collaborators
Hospital Vall d'Hebron
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1. Study Identification

Unique Protocol Identification Number
NCT04971148
Brief Title
Correlation of Peak Tidal Inspiratory Flow Measured Before and After Extubation in Adult Patients With Hypoxemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in recruiting patients
Study Start Date
April 7, 2022 (Actual)
Primary Completion Date
August 8, 2023 (Actual)
Study Completion Date
August 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center
Collaborators
Hospital Vall d'Hebron

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxemic Respiratory Failure
Keywords
high-flow nasal cannula, flow setting, peak tidal inspiratory flow, hypoxemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HFNC flow set at patient peak tidal inspiratory flow
Arm Type
Active Comparator
Arm Description
HFNC flow will be set at the level that matches patient peak tidal inspiratory flow
Arm Title
HFNC flow set at 1.33 times of patient peak tidal inspiratory flow
Arm Type
Experimental
Arm Description
HFNC flow will be set at the level that is 1.33 times of patient peak tidal inspiratory flow
Arm Title
HFNC flow set at 1.67 times of patient peak tidal inspiratory flow
Arm Type
Experimental
Arm Description
HFNC flow will be set at the level that is 1.67 times of patient peak tidal inspiratory flow
Arm Title
HFNC flow set at 2 times of patient peak tidal inspiratory flow
Arm Type
Experimental
Arm Description
HFNC flow will be set at the level that is 2 times of patient peak tidal inspiratory flow
Intervention Type
Other
Intervention Name(s)
HFNC flow set at patient peak tidal inspiratory flow
Intervention Description
HFNC flow will be set at the level equal to patient peak tidal inspiratory flow
Intervention Type
Other
Intervention Name(s)
HFNC flow set at 1.33 times of patient peak tidal inspiratory flow
Intervention Description
HFNC flow will be set at 1.33 times of patient peak tidal inspiratory flow
Intervention Type
Other
Intervention Name(s)
HFNC flow set at 1.67 times of patient peak tidal inspiratory flow
Intervention Description
HFNC flow will be set at 1.67 times of patient peak tidal inspiratory flow
Intervention Type
Other
Intervention Name(s)
HFNC flow set at 2 times of patient peak tidal inspiratory flow
Intervention Description
HFNC flow will be set 2 times of patient peak tidal inspiratory flow
Primary Outcome Measure Information:
Title
SpO2/FIO2
Description
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
Time Frame
20 minutes after each flow setting
Secondary Outcome Measure Information:
Title
End-expiratory lung volume assessed by EIT
Description
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
Time Frame
20 minutes after each flow setting
Title
self-evaluated comfort
Description
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
Time Frame
20 minutes after each flow setting

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Li, PhD
Organizational Affiliation
Rush University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush university medical center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified patient data will be shared upon reasonable request 3 months after publication.
IPD Sharing Time Frame
3 months after the study is published
IPD Sharing Access Criteria
the investigators need to send their IRB approved research protocol to Jie_li@rush.edu
Citations:
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Citation
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Results Reference
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Correlation of Peak Tidal Inspiratory Flow Measured Before and After Extubation in Adult Patients With Hypoxemia

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