Association Between P0.1 and Extubation Failure in Adult Patients with Acute Hypoxemic Respiratory Failure. a Multicenter Prospective Cohort Study

NCT06662201 | Active Not Recruiting DMC

• 1 other identifier: P01
• Study Type: observational
• Target: 256
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of follow-up at day 7

Secondary Outcomes (1)

• Cut-off point of P01

  From enrollment to the end of follow-up at day 7

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• Tracheostomized patients
• Patients with neuromuscular disease (For example: Guillain Barré,
• Myasthenia Gravis, Amyotrophic lateral sclerosis, etc.)
• Patients with a decision not to reintubate

Sponsors & Collaborators

• Argentinian Intensive Care Society: lead

Study Sites (1)

Sanatorio Anchorena Recoleta

Buenos Aires, Buenos Aires F.D., 1425, Argentina

Location

Related Publications (15)

• 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.

  PMID: 14608459 BACKGROUND

• Thille 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.

  PMID: 36286317 BACKGROUND

• Sato 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.

  PMID: 33012587 BACKGROUND

• Spinelli 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.

  PMID: 32016537 BACKGROUND

• Alberti 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.

  PMID: 7593895 BACKGROUND

• Telias 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.

  PMID: 29350241 BACKGROUND

• Whitelaw 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.

  PMID: 1144940 BACKGROUND

• MacIntyre 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.

  PMID: 11742959 BACKGROUND

• Ely 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.

  PMID: 8948561 BACKGROUND

• Thille 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.

  PMID: 21765357 BACKGROUND

• Yu 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.

  PMID: 31990295 BACKGROUND

• Ionescu 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.

  PMID: 34074160 BACKGROUND

• Dorado 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.

  PMID: 36379638 BACKGROUND

• Thille 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.

  PMID: 23235542 BACKGROUND

• Pham 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.

  PMID: 36693401 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: August 29, 2024
• Primary Completion: August 29, 2025
• Study Completion: August 29, 2025
• Last Updated: October 28, 2024

Record last verified: 2024-09

Locations

AR (1)