Clinical trial NCT06746363: The Effectiveness of High-flow Nasal Cannula After Extubation in Patients
Official title: The Effectiveness of High-flow Nasal Cannula After Extubation in Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Extubation Respiratory Failure
Keywords: post extubation
HFNC
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sample Size: The sample size was calculated using the G Power statistical software with a chi-square test. Parameters used were effect size: 0.3, alpha: 0.05, and power: 0.8. Based on these conditions, the required sample size is estimated to be 88 participants.

Experimental Group: Comprising 44 PMV (Prolonged Mechanical Ventilation) patients who, after extubation, are assessed by physicians to use high-flow nasal cannula oxygen therapy.

Control Group: Comprising 44 PMV patients who, after extubation, are assessed by physicians to use traditional oxygen therapy.

Brief summary: Observe the current status of prolonged mechanical ventilation (PMV) patients using high-flow nasal cannula oxygen therapy (experimental group) or traditional oxygen therapy (control group) after extubation, and compare the differences in ventilator weaning rates between the two groups.

Record the ROX index (SpO2/FiO2/RR) at 2, 6, 12, and 24 hours after extubation in PMV patients and explore whether statistical methods can predict the weaning outcome within seven days.

Use statistical methods to analyze whether comorbidities in the PMV population affect ventilator weaning rates.


Eligibility criteria: Inclusion Criteria:

* Patients over 20 years old and expected to undergo extubation.

Exclusion Criteria:

* Patients with tracheostomy who will use non-invasive or invasive ventilators immediately after extubation.

Primary outcomes:
measure: ROX index
timeFrame: From enrollment to preliminary data compilation, lasting a total of 4 months.
measure: P/F ratio
timeFrame: From enrollment to preliminary data compilation, lasting a total of 4 months.
Secondary outcomes:
Other outcomes:
measure: Area Under Curve (AUC)
timeFrame: From enrollment to the end of treatment at 1.5 year
measure: Receiver Operating Characteristic (ROC) curve
timeFrame: From enrollment to the end of treatment at 1.5 year
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
References:
citation: Fernandez R, Subira C, Frutos-Vivar F, Rialp G, Laborda C, Masclans JR, Lesmes A, Panadero L, Hernandez G. High-flow nasal cannula to prevent postextubation respiratory failure in high-risk non-hypercapnic patients: a randomized multicenter trial. Ann Intensive Care. 2017 Dec;7(1):47. doi: 10.1186/s13613-017-0270-9. Epub 2017 May 2.
citation: Lee YS, Chang SW, Sim JK, Kim S, Kim JH. An Integrated Model including the ROX Index to Predict the Success of High-Flow Nasal Cannula Use after Planned Extubation: A Retrospective Observational Cohort Study. J Clin Med. 2021 Aug 10;10(16):3513. doi: 10.3390/jcm10163513.
citation: Rochwerg B, Granton D, Wang DX, Helviz Y, Einav S, Frat JP, Mekontso-Dessap A, Schreiber A, Azoulay E, Mercat A, Demoule A, Lemiale V, Pesenti A, Riviello ED, Mauri T, Mancebo J, Brochard L, Burns K. High flow nasal cannula compared with conventional oxygen therapy for acute hypoxemic respiratory failure: a systematic review and meta-analysis. Intensive Care Med. 2019 May;45(5):563-572. doi: 10.1007/s00134-019-05590-5. Epub 2019 Mar 19.
citation: Roca O, Messika J, Caralt B, Garcia-de-Acilu M, Sztrymf B, Ricard JD, Masclans JR. Predicting success of high-flow nasal cannula in pneumonia patients with hypoxemic respiratory failure: The utility of the ROX index. J Crit Care. 2016 Oct;35:200-5. doi: 10.1016/j.jcrc.2016.05.022. Epub 2016 May 31.