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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04971148
Enrollment
5
Registered
2021-07-21
Start date
2022-04-07
Completion date
2023-08-08
Last updated
2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxemic Respiratory Failure

Keywords

high-flow nasal cannula, flow setting, peak tidal inspiratory flow, hypoxemia

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.

Interventions

OTHERHFNC flow set at patient peak tidal inspiratory flow

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

OTHERHFNC 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

OTHERHFNC 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

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

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

Sponsors

Hospital Vall d'Hebron
CollaboratorOTHER
Rush University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

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)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
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

Design outcomes

Primary

MeasureTime frameDescription
SpO2/FIO220 minutes after each flow settingTwenty 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

MeasureTime frameDescription
End-expiratory lung volume assessed by EIT20 minutes after each flow settingTwenty 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 comfort20 minutes after each flow settingTwenty 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

Countries

Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026