The Effectiveness of High-flow Nasal Cannula After Extubation in Patients

NCT06746363 | Completed DMC

• 1 other identifier: 202200799B0
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Extubation Respiratory Failure

Keywords

post extubation; HFNC

Outcome Measures

Primary Outcomes (2)

• ROX index

  The oxygen concentration used before and after oxygen therapy adjustment is recorded as percent, accompanied by clinical and physiological parameter the patient's oxygen saturation (SpO₂) and respiratory rate (breaths per minute). Additionally, multiple measurements of the ROX index are performed, combining saturation (SpO₂), FiO₂, and respiratory rate to calculate and report the ROX index (SpO₂ / FiO₂ / RR).

  From enrollment to preliminary data compilation, lasting a total of 4 months.

• P/F ratio

  Collect the arterial oxygen partial pressure (PaO₂, mmHg) from each patient's clinical arterial blood dialysis, and compare it with the oxygen concentration (%) being used at the time. The two values are then combined to calculate the P/F ratio (PaO₂, mmHg / FiO₂, decimal).

  From enrollment to preliminary data compilation, lasting a total of 4 months.

Other Outcomes (2)

• Area Under Curve (AUC)

  From enrollment to the end of treatment at 1.5 year

• Receiver Operating Characteristic (ROC) curve

  From enrollment to the end of treatment at 1.5 year

Study Arms (2)

HFNC group

HFNC support post extubation

oxygen therapy

oxygen therapy post extubation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

Related Publications (4)

• 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.

  PMID: 28466461 RESULT

• 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.

  PMID: 34441809 RESULT

• 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.

  PMID: 30888444 RESULT

• 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.

  PMID: 27481760 RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 24, 2024
• Study Start: June 15, 2022
• Primary Completion: January 15, 2024
• Study Completion: March 20, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)