Clinical trial NCT04971148: 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
Overall status: TERMINATED
Phase: NA
Conditions: Hypoxemic Respiratory Failure
Keywords: high-flow nasal cannula
flow setting
peak tidal inspiratory flow
hypoxemia
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Hospital Vall d'Hebron
First posted: 2021-07-21
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: SpO2/FIO2
timeFrame: 20 minutes after each flow setting
Secondary outcomes:
measure: End-expiratory lung volume assessed by EIT
timeFrame: 20 minutes after each flow setting
measure: self-evaluated comfort
timeFrame: 20 minutes after each flow setting
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush university medical center
state: Illinois
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
Study officials:
affiliation: Rush University
name: Jie Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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