Post Extubation Respiratory FailureNCT06746363
The Effectiveness of High-flow Nasal Cannula After Extubation in Patients
An observational study of Post Extubation Respiratory Failure, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post Extubation Respiratory Failure
- How many people
- 110 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Jun 2022to 20 Mar 2024
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients over 20 years old and expected to undergo extubation.
Who cannot join
- Patients with tracheostomy who will use non-invasive or invasive ventilators immediately after extubation.
Trial locations and contacts
1 site in 1 country.
About this study
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HFNC group | HFNC support post extubation | |
| oxygen therapy | oxygen therapy post extubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: From enrollment to preliminary data compilation, lasting a total of 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start15 Jun 2022
- Primary completion15 Jan 2024
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post Extubation Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lo Tzu Han, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746363
- Sponsor's protocol ID
- 202200799B0
- Status last verified
- Dec 2024
- First submitted
- 29 Nov 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: this study is the result of collaborative efforts by co-researchers.
Publications
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.
PubMed 28466461Lee 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.
PubMed 34441809Rochwerg 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.
PubMed 30888444Roca 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.
PubMed 27481760
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of High-flow Nasal Cannula After Extubation in Patients
- ClinicalTrials.gov ID
- NCT06746363
- Acronym / sponsor ID
- 202200799B0
- Conditions
- Post Extubation Respiratory Failure
- Keywords
- post extubation, HFNC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFNC group | – | –HFNC support post extubation |
| oxygen therapy | – | –oxygen therapy post extubation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients over 20 years old and expected to undergo extubation.
Key exclusion criteria (1 listed)
- Patients with tracheostomy who will use non-invasive or invasive ventilators immediately after extubation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ROX index
Time frame: From enrollment to preliminary data compilation, lasting a total of 4 months.
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).
P/F ratio
Time frame: From enrollment to preliminary data compilation, lasting a total of 4 months.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Results publication: PubMed 28466461Fernandez 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.
- Results publication: PubMed 34441809Lee 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.
- Results publication: PubMed 30888444Rochwerg 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.
- Results publication: PubMed 27481760Roca 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.
- Individual participant dataSharing planned: Yes. this study is the result of collaborative efforts by co-researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Extubation Respiratory Failure, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ROX index (time frame: From enrollment to preliminary data compilation, lasting a total of 4 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06746363, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.