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

Not Applicable

Terminated

• Conditions: Hypoxemic Respiratory Failure
• Interventions: 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 patient peak tidal inspiratory flow; Other: HFNC flow set at 2 times of patient peak tidal inspiratory flow

• Registration Number: NCT04971148
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2021-07-12
• Study First Submitted QC: 2021-07-12
• Study First Posted: 2021-07-21
• Study Start: 2022-04-07
• Status Verified: 2023-08
• Primary Completion: 2023-08-08
• Study Completion: 2023-08-08
• Last Update Submitted: 2023-08-08
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HFNC flow set at 1.33 times of patient peak tidal inspiratory flow	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
HFNC flow set at 1.67 times of patient peak tidal inspiratory flow	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
HFNC flow set at patient peak tidal inspiratory flow	HFNC flow set at patient peak tidal inspiratory flow	HFNC flow will be set at the level that matches patient peak tidal inspiratory flow
HFNC flow set at 2 times of patient peak tidal inspiratory flow	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (2)

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain

Rush university medical center; 🇺🇸 Chicago, Illinois, United States