Ventilator WeaningNCT06662201
Association Between P0.1 and Extubation Failure in Adult Patients With Acute Hypoxemic Respiratory Failure. A Multicenter Prospective Cohort Study
An observational study of Ventilator Weaning, run by Argentinian Intensive Care Society at 1 site in Argentina.
Trial summary
The goal of this observational study is to learn about the effect of the occlusion pressure during the first 100 miliseconds (P01) over the extubation failure in participants receiving mechanical ventilation for acute respiratory failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Weaning
- How many people
- 256 participants
- Where
- 1 siteArgentina
- Study dates
- 29 Aug 2024to 29 Aug 2025
- How long will I take part?
- 7 Days
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (over 17 years of age) who have required intubation and connection to mechanical ventilation due to acute respiratory failure hypoxemia for more than 24 hours, who have overcome a PVE and are ready to be extubated in the Intensive Care Units of the metropolitan area of Buenos Aires (AMBA).
Who may be able to join
- Patients over 17 years of age
- Patients receiving invasive mechanical ventilation for more than 24 hours
- Patients who have been ventilated for acute hypoxemic respiratory failure
- Patients who overcome a PVE
- Patients who, after overcoming the PVE, meet the conditions to be extubated immediately after, according to the team of treating professionals who conduct the weaning
- Patients who are in their first attempt at extubation
Who cannot join
- Tracheostomized patients
- Patients with neuromuscular disease (For example: Guillain Barré,
- Myasthenia Gravis, Amyotrophic lateral sclerosis, etc.)
- Patients with a decision not to reintubate
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Sanatorio Anchorena Recoleta
Buenos Aires, Buenos Aires F.D., 1425
About this study
The goal of this observational study is to learn about the effect of the occlusion pressure during the first 100 miliseconds (P01) over the extubation failure in participants receiving mechanical ventilation for acute respiratory failure.
The main question it aims to answer is:
Are high P0.1 values (≥3 cmH2O) measured 30 minutes after starting a spontaneous breathing trial associated with extubation failure in adult patients who were intubated for acute hypoxemic respiratory failure?
- Conditions
- Ventilator Weaning
- Keywords
- Respiration, artificial, Positive-Pressure Respiration
- Medical subject headings
- Respiratory Aspiration
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 |
|---|---|---|
| Acute respiratory failure | Adult patients (over 17 years of age) who have been intubated for acute respiratory failure hypoxemia for more than 24 hours, who have overcome a spontaneous breathing trial (SBT) and are fit to be extubated in the intensive care unit of the participating centers, who meet the inclusion criteria, who do not have exclusion criteria and from whom informed consent is obtained (from them or their immediate family member). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation failure
Extubation failure is defined as reintubation by day 7. The decision to reintubate a patient will be made by the treating team, who will be blinded to the P0.1 values measured during spontaneus breathing trial.
Measured: From enrollment to the end of follow-up at day 7
Secondary outcomes (1)
Cut-off point of P01
To identify the best cut-off point of P0.1 to predict extubation failure in adult patients who required invasive mechanical ventilation for acute hypoxemic respiratory failure.
Measured: From enrollment to the end of follow-up at day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start29 Aug 2024
- Primary completion29 Aug 2025 (estimated)
- Study completion29 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Ventilator WeaningStudies of the same condition, open and under way.
- 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
- 256 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Argentinian Intensive Care Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662201
- Sponsor's protocol ID
- P01
- Status last verified
- Sep 2024
- First submitted
- 25 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fernandez R, Raurich JM, Mut T, Blanco J, Santos A, Villagra A. Extubation failure: diagnostic value of occlusion pressure (P0.1) and P0.1-derived parameters. Intensive Care Med. 2004 Feb;30(2):234-240. doi: 10.1007/s00134-003-2070-y. Epub 2003 Nov 8.
PubMed 14608459Thille AW, Gacouin A, Coudroy R, Ehrmann S, Quenot JP, Nay MA, Guitton C, Contou D, Labro G, Reignier J, Pradel G, Beduneau G, Dangers L, Saccheri C, Prat G, Lacave G, Sedillot N, Terzi N, La Combe B, Mira JP, Romen A, Azais MA, Rouze A, Devaquet J, Delbove A, Dres M, Bourenne J, Lautrette A, de Keizer J, Ragot S, Frat JP; REVA Research Network. Spontaneous-Breathing Trials with Pressure-Support Ventilation or a T-Piece. N Engl J Med. 2022 Nov 17;387(20):1843-1854. doi: 10.1056/NEJMoa2209041. Epub 2022 Oct 26.
PubMed 36286317Sato R, Hasegawa D, Hamahata NT, Narala S, Nishida K, Takahashi K, Sempokuya T, Daoud EG. The predictive value of airway occlusion pressure at 100 msec (P0.1) on successful weaning from mechanical ventilation: A systematic review and meta-analysis. J Crit Care. 2021 Jun;63:124-132. doi: 10.1016/j.jcrc.2020.09.030. Epub 2020 Sep 30.
PubMed 33012587Spinelli E, Mauri T, Beitler JR, Pesenti A, Brodie D. Respiratory drive in the acute respiratory distress syndrome: pathophysiology, monitoring, and therapeutic interventions. Intensive Care Med. 2020 Apr;46(4):606-618. doi: 10.1007/s00134-020-05942-6. Epub 2020 Feb 3.
PubMed 32016537Alberti A, Gallo F, Fongaro A, Valenti S, Rossi A. P0.1 is a useful parameter in setting the level of pressure support ventilation. Intensive Care Med. 1995 Jul;21(7):547-53. doi: 10.1007/BF01700158.
PubMed 7593895Telias I, Damiani F, Brochard L. The airway occlusion pressure (P0.1) to monitor respiratory drive during mechanical ventilation: increasing awareness of a not-so-new problem. Intensive Care Med. 2018 Sep;44(9):1532-1535. doi: 10.1007/s00134-018-5045-8. Epub 2018 Jan 19. No abstract available.
PubMed 29350241Whitelaw WA, Derenne JP, Milic-Emili J. Occlusion pressure as a measure of respiratory center output in conscious man. Respir Physiol. 1975 Mar;23(2):181-99. doi: 10.1016/0034-5687(75)90059-6.
PubMed 1144940MacIntyre NR, Cook DJ, Ely EW Jr, Epstein SK, Fink JB, Heffner JE, Hess D, Hubmayer RD, Scheinhorn DJ; American College of Chest Physicians; American Association for Respiratory Care; American College of Critical Care Medicine. Evidence-based guidelines for weaning and discontinuing ventilatory support: a collective task force facilitated by the American College of Chest Physicians; the American Association for Respiratory Care; and the American College of Critical Care Medicine. Chest. 2001 Dec;120(6 Suppl):375S-95S. doi: 10.1378/chest.120.6_suppl.375s. No abstract available.
PubMed 11742959Ely EW, Baker AM, Dunagan DP, Burke HL, Smith AC, Kelly PT, Johnson MM, Browder RW, Bowton DL, Haponik EF. Effect on the duration of mechanical ventilation of identifying patients capable of breathing spontaneously. N Engl J Med. 1996 Dec 19;335(25):1864-9. doi: 10.1056/NEJM199612193352502.
PubMed 8948561Thille AW, Harrois A, Schortgen F, Brun-Buisson C, Brochard L. Outcomes of extubation failure in medical intensive care unit patients. Crit Care Med. 2011 Dec;39(12):2612-8. doi: 10.1097/CCM.0b013e3182282a5a.
PubMed 21765357Yu H, Luo J, Ni Y, Hu Y, Liu D, Wang M, Liang B, Liang Z. Early prediction of extubation failure in patients with severe pneumonia: a retrospective cohort study. Biosci Rep. 2020 Feb 28;40(2):BSR20192435. doi: 10.1042/BSR20192435.
PubMed 31990295Ionescu F, Zimmer MS, Petrescu I, Castillo E, Bozyk P, Abbas A, Abplanalp L, Dogra S, Nair GB. Extubation Failure in Critically Ill COVID-19 Patients: Risk Factors and Impact on In-Hospital Mortality. J Intensive Care Med. 2021 Sep;36(9):1018-1024. doi: 10.1177/08850666211020281. Epub 2021 Jun 2.
PubMed 34074160Dorado JH, Navarro E, Plotnikow GA, Gogniat E, Accoce M; EpVAr Study Group. Epidemiology of Weaning From Invasive Mechanical Ventilation in Subjects With COVID-19. Respir Care. 2023 Jan;68(1):101-109. doi: 10.4187/respcare.09925. Epub 2022 Nov 15.
PubMed 36379638Thille AW, Cortes-Puch I, Esteban A. Weaning from the ventilator and extubation in ICU. Curr Opin Crit Care. 2013 Feb;19(1):57-64. doi: 10.1097/MCC.0b013e32835c5095.
PubMed 23235542Pham T, Heunks L, Bellani G, Madotto F, Aragao I, Beduneau G, Goligher EC, Grasselli G, Laake JH, Mancebo J, Penuelas O, Piquilloud L, Pesenti A, Wunsch H, van Haren F, Brochard L, Laffey JG; WEAN SAFE Investigators. Weaning from mechanical ventilation in intensive care units across 50 countries (WEAN SAFE): a multicentre, prospective, observational cohort study. Lancet Respir Med. 2023 May;11(5):465-476. doi: 10.1016/S2213-2600(22)00449-0. Epub 2023 Jan 21.
PubMed 36693401
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between P0.1 and Extubation Failure in Adult Patients With Acute Hypoxemic Respiratory Failure. A Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06662201
- Acronym / sponsor ID
- P01
- Conditions
- Ventilator Weaning
- Keywords
- Respiration, artificial, Positive-Pressure Respiration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Argentinian Intensive Care SocietyUniversity, hospital or other
- Study start
- 29 Aug 2024 (actual)
- Primary completion
- 29 Aug 2025 (estimated)
- Study completion
- 29 Aug 2025 (estimated)
- First posted
- 28 Oct 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.
The goal of this observational study is to learn about the effect of the occlusion pressure during the first 100 miliseconds (P01) over the extubation failure in participants receiving mechanical ventilation for acute respiratory failure.
The main question it aims to answer is:
Are high P0.1 values (≥3 cmH2O) measured 30 minutes after starting a spontaneous breathing trial associated with extubation failure in adult patients who were intubated for acute hypoxemic respiratory failure?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute respiratory failure | – | –Adult patients (over 17 years of age) who have been intubated for acute respiratory failure hypoxemia for more than 24 hours, who have overcome a spontaneous breathing trial (SBT) and are fit to be extubated in the intensive care unit of the participating centers, who meet the inclusion criteria, who do not have exclusion criteria and from whom informed consent is obtained (from them or their immediate family member). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (over 17 years of age) who have required intubation and connection to mechanical ventilation due to acute respiratory failure hypoxemia for more than 24 hours, who have overcome a PVE and are ready to be extubated in the Intensive Care Units of the metropolitan area of Buenos Aires (AMBA).
Key inclusion criteria (6 listed)
- Patients over 17 years of age
- Patients receiving invasive mechanical ventilation for more than 24 hours
- Patients who have been ventilated for acute hypoxemic respiratory failure
- Patients who overcome a PVE
- Patients who, after overcoming the PVE, meet the conditions to be extubated immediately after, according to the team of treating professionals who conduct the weaning
Key exclusion criteria (4 listed)
- Tracheostomized patients
- Patients with neuromuscular disease (For example: Guillain Barré,
- Myasthenia Gravis, Amyotrophic lateral sclerosis, etc.)
- Patients with a decision not to reintubate
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
Extubation failure
Time frame: From enrollment to the end of follow-up at day 7
Extubation failure is defined as reintubation by day 7. The decision to reintubate a patient will be made by the treating team, who will be blinded to the P0.1 values measured during spontaneus breathing trial.
1 secondary outcome
Cut-off point of P01
Time frame: From enrollment to the end of follow-up at day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Results publication: PubMed 14608459Fernandez R, Raurich JM, Mut T, Blanco J, Santos A, Villagra A. Extubation failure: diagnostic value of occlusion pressure (P0.1) and P0.1-derived parameters. Intensive Care Med. 2004 Feb;30(2):234-240. doi: 10.1007/s00134-003-2070-y. Epub 2003 Nov 8.
- Results publication: PubMed 36286317Thille AW, Gacouin A, Coudroy R, Ehrmann S, Quenot JP, Nay MA, Guitton C, Contou D, Labro G, Reignier J, Pradel G, Beduneau G, Dangers L, Saccheri C, Prat G, Lacave G, Sedillot N, Terzi N, La Combe B, Mira JP, Romen A, Azais MA, Rouze A, Devaquet J, Delbove A, Dres M, Bourenne J, Lautrette A, de Keizer J, Ragot S, Frat JP; REVA Research Network. Spontaneous-Breathing Trials with Pressure-Support Ventilation or a T-Piece. N Engl J Med. 2022 Nov 17;387(20):1843-1854. doi: 10.1056/NEJMoa2209041. Epub 2022 Oct 26.
- Results publication: PubMed 33012587Sato R, Hasegawa D, Hamahata NT, Narala S, Nishida K, Takahashi K, Sempokuya T, Daoud EG. The predictive value of airway occlusion pressure at 100 msec (P0.1) on successful weaning from mechanical ventilation: A systematic review and meta-analysis. J Crit Care. 2021 Jun;63:124-132. doi: 10.1016/j.jcrc.2020.09.030. Epub 2020 Sep 30.
- Results publication: PubMed 32016537Spinelli E, Mauri T, Beitler JR, Pesenti A, Brodie D. Respiratory drive in the acute respiratory distress syndrome: pathophysiology, monitoring, and therapeutic interventions. Intensive Care Med. 2020 Apr;46(4):606-618. doi: 10.1007/s00134-020-05942-6. Epub 2020 Feb 3.
- Results publication: PubMed 7593895Alberti A, Gallo F, Fongaro A, Valenti S, Rossi A. P0.1 is a useful parameter in setting the level of pressure support ventilation. Intensive Care Med. 1995 Jul;21(7):547-53. doi: 10.1007/BF01700158.
- Results publication: PubMed 29350241Telias I, Damiani F, Brochard L. The airway occlusion pressure (P0.1) to monitor respiratory drive during mechanical ventilation: increasing awareness of a not-so-new problem. Intensive Care Med. 2018 Sep;44(9):1532-1535. doi: 10.1007/s00134-018-5045-8. Epub 2018 Jan 19. No abstract available.
- Results publication: PubMed 1144940Whitelaw WA, Derenne JP, Milic-Emili J. Occlusion pressure as a measure of respiratory center output in conscious man. Respir Physiol. 1975 Mar;23(2):181-99. doi: 10.1016/0034-5687(75)90059-6.
- Results publication: PubMed 11742959MacIntyre NR, Cook DJ, Ely EW Jr, Epstein SK, Fink JB, Heffner JE, Hess D, Hubmayer RD, Scheinhorn DJ; American College of Chest Physicians; American Association for Respiratory Care; American College of Critical Care Medicine. Evidence-based guidelines for weaning and discontinuing ventilatory support: a collective task force facilitated by the American College of Chest Physicians; the American Association for Respiratory Care; and the American College of Critical Care Medicine. Chest. 2001 Dec;120(6 Suppl):375S-95S. doi: 10.1378/chest.120.6_suppl.375s. No abstract available.
- Results publication: PubMed 8948561Ely EW, Baker AM, Dunagan DP, Burke HL, Smith AC, Kelly PT, Johnson MM, Browder RW, Bowton DL, Haponik EF. Effect on the duration of mechanical ventilation of identifying patients capable of breathing spontaneously. N Engl J Med. 1996 Dec 19;335(25):1864-9. doi: 10.1056/NEJM199612193352502.
- Results publication: PubMed 21765357Thille AW, Harrois A, Schortgen F, Brun-Buisson C, Brochard L. Outcomes of extubation failure in medical intensive care unit patients. Crit Care Med. 2011 Dec;39(12):2612-8. doi: 10.1097/CCM.0b013e3182282a5a.
- Results publication: PubMed 31990295Yu H, Luo J, Ni Y, Hu Y, Liu D, Wang M, Liang B, Liang Z. Early prediction of extubation failure in patients with severe pneumonia: a retrospective cohort study. Biosci Rep. 2020 Feb 28;40(2):BSR20192435. doi: 10.1042/BSR20192435.
- Results publication: PubMed 34074160Ionescu F, Zimmer MS, Petrescu I, Castillo E, Bozyk P, Abbas A, Abplanalp L, Dogra S, Nair GB. Extubation Failure in Critically Ill COVID-19 Patients: Risk Factors and Impact on In-Hospital Mortality. J Intensive Care Med. 2021 Sep;36(9):1018-1024. doi: 10.1177/08850666211020281. Epub 2021 Jun 2.
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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 Ventilator Weaning, run by Argentinian Intensive Care Society at 1 site in Argentina.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Oct 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 Argentina. 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?
Results are not available in the source record.
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?
Extubation failure (time frame: From enrollment to the end of follow-up at day 7). 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 NCT06662201, which also lists 15 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 28 Oct 2024.