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

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ClinicalTrials.gov Identifier: NCT04971148
Recruitment Status : Recruiting
First Posted : July 21, 2021
Last Update Posted : May 6, 2022
Sponsor:
Collaborator:
Hospital Vall d'Hebron
Information provided by (Responsible Party):
Rush University Medical Center

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
Hypoxemic Respiratory Failure 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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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)
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 : April 7, 2022
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : December 2022

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




Primary Outcome Measures :
  1. SpO2/FIO2 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04971148


Contacts
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Contact: Jie Li, PhD 312-563-4643 jie_li@rush.edu
Contact: Brady Scott, PhD 312-942-6389 Jonathan_B_Scott@rush.edu

Locations
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United States, Illinois
Rush university medical center Recruiting
Chicago, Illinois, United States, 60612
Contact: Jie Li, PhD         
Spain
Hospital Universitari Vall d'Hebron Not yet recruiting
Barcelona, Spain
Contact: Oriol Roca, MD         
Sponsors and Collaborators
Rush University Medical Center
Hospital Vall d'Hebron
Investigators
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Principal Investigator: Jie Li, PhD Rush University
Publications of Results:
Other Publications:

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Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT04971148    
Other Study ID Numbers: HFNC-Flow-004
First Posted: July 21, 2021    Key Record Dates
Last Update Posted: May 6, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified patient data will be shared upon reasonable request 3 months after publication.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: 3 months after the study is published
Access Criteria: the investigators need to send their IRB approved research protocol to Jie_li@rush.edu

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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:
high-flow nasal cannula
flow setting
peak tidal inspiratory flow
hypoxemia
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiratory Aspiration
Hypoxia
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Signs and Symptoms, Respiratory