Lung Volume Preservation During Extubation

NCT05526053 | Completed

• 1 other identifier: CEI 22/67
• Study Type: interventional
• Target: 1,753
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: At present, the best spontaneous breathing trial (SBT) during weaning from mechanical ventilation is a 30-min test with pressure support (PSV) 8 cmH2O without positive end-expiratory pressure (PEEP). There is a debate about the possible collapse of some alveolar units during such SBT and during extubation with continuous suctioning. A few experiences show extubation without suctioning as feasible and safe. Lung ultrasound is a non invasive and useful exploration tool to assess the lung aeration. Hypothesis: Techniques aimed at preserving lung volume during SBT and extubation can yield higher rates of successful extubation. The preserved lung volume of each SBT and extubation strategy can be assessed by using lung ultrasound. Primary objective: To define the rates of successful extubation in two extubation approaches aiming at different levels of lung volume preservation: standard SBT (30-min PSV 8 cmH2O without PEEP followed by extubation with continuous suctioning) versus experimental SBT (PSV8+ PEEP 5 cmH2O followed by extubation without suctioning). To define the lung aeration levels using the modified Lung Ultrasound Score (LUS) of each SBT strategy. Secondary objectives: Reintubation rate, ICU and hospital stays, and mortality in each group. To define the diaphragm and intercostal thickness and thickening fraction in different levels of lung volume preservation. Design: Prospective, multicenter, randomized study. Two opposing extubation strategies are compared in randomly assigned patients.The level of aeration is assessed using lung ultrasound.

Conditions

Weaning Failure; Pulmonary Collapse

Keywords

Weaning from Mechanical Ventilation; Reintubation; Lung Ultrasound Score; Diaphragm and intercostal thickness and thickening fraction

Outcome Measures

Primary Outcomes (1)

• Rate of Successful extubation

  Number of patients free of mechanical ventilation

  72 hours

Secondary Outcomes (9)

• Modified Lung Ultrasound Score (LUSm) at the end of the SBT and after extubation.

  72 hours

• Rate of Reintubation

  72 hours

• Rate of ICU Mortality

  90 days

• Rate of Hospital Mortality

  90 days

• Rate of Long term survival

  90 days

Other Outcomes (4)

• Diaphragm thickness at the beginning and at the end of the SBT.

  72 hours

• Diaphragm thickening fraction at the beginning and at the end of the SBT.

  72 hours

• Intercostal thickness at the beginning and at the end of the SBT.

  72 hours

Study Arms (2)

Standard

NO INTERVENTION

SBT: PSV 8 cmH2O, PEEP 0 cmH2O for 30 minutes and, when successful, followed by extubation with continuous suctioning. Patients included in the ultrasound nested study: * Diaphragm and intercostal thickness and thickening fraction at the beginning and the end of the SBT. * Modified LUS at the beginning of the SBT, at the end of the SBT and after extubation if successful SBT.

Lung Volume Preservation

EXPERIMENTAL

SBT: PSV 8 cmH2O, PEEP 5 cmH2O for 30 minutes and, when successful, followed by direct extubation without suctioning and connected to the ventilator with PEEP 5 cmH2O. Patients included in the ultrasound part: * Diaphragm and intercostal thickness and thickening fraction at the beginning and the end of the SBT. * Modified LUS at the beginning of the SBT, at the end of SBT and after extubation if successful SBT.

Other: Lung volume preservation

Interventions

Lung volume preservation OTHER

Extubate the patient connected to the ventilator and PEEP of 5 cmH2O after a successful SBT also using PEEP.

Lung Volume Preservation

Eligibility Criteria

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

You may qualify if:

• Patients\> 18 years who meet weaning criteria (see below)
• More than 24 hours of mechanical ventilation (MV)
• Signed Informed Consent by a substitute decision maker (SDM).
• Weaning Criteria:
• Suitable cough (Ability to raise secretions to the endotracheal tube) (or Maximal inspiratory pressure (MIP) \< -15 cmH2O).
• Absence of excessive secretions (\<3 aspirations in the last 8 hours).
• Resolution or improvement of the pathology that led to intubation.
• Clinical stability (Heart Rate (HR) \<140 bpm, Systolic Blood Pressure (SBP) 90-160, without vasopressors or at minimum doses).
• Adequate oxygenation (SatO2\> 90% with Inspiratory Fraction of oxygen (FiO2) \<0.4).
• Adequate ventilatory mechanics (Respiratory rate (RR) \<35 rpm, Tidal Volume (TV) \> 5 ml / kg, RR / TV \<100 rpm/l).
• Confident awareness level (Glasgow Coma Scale (GCS)\> 13).

You may not qualify if:

• tracheostomy, do-not-reintubate orders, decision of the responsible physician (e.g., due to a preference for a particular weaning technique according to the underlying pathology), absence of informed consent, mental incapacity without legal representation.
• For ultrasound assessment: skilled explorer not present at the time of the SBT, inadequate ultrasound window. Known diaphragmatic paralysis.

Sponsors & Collaborators

• Althaia Xarxa Assistencial Universitària de Manresa: lead

Study Sites (1)

Althaia Xarxa Assistencial

Manresa, Bacelona, 08243, Spain

Location

Related Publications (12)

• Brochard L, Rauss A, Benito S, Conti G, Mancebo J, Rekik N, Gasparetto A, Lemaire F. Comparison of three methods of gradual withdrawal from ventilatory support during weaning from mechanical ventilation. Am J Respir Crit Care Med. 1994 Oct;150(4):896-903. doi: 10.1164/ajrccm.150.4.7921460.

  PMID: 7921460 BACKGROUND

• Esteban A, Alia I, Tobin MJ, Gil A, Gordo F, Vallverdu I, Blanch L, Bonet A, Vazquez A, de Pablo R, Torres A, de La Cal MA, Macias S. Effect of spontaneous breathing trial duration on outcome of attempts to discontinue mechanical ventilation. Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med. 1999 Feb;159(2):512-8. doi: 10.1164/ajrccm.159.2.9803106.

  PMID: 9927366 BACKGROUND

• Esteban A, Alia I, Gordo F, Fernandez R, Solsona JF, Vallverdu I, Macias S, Allegue JM, Blanco J, Carriedo D, Leon M, de la Cal MA, Taboada F, Gonzalez de Velasco J, Palazon E, Carrizosa F, Tomas R, Suarez J, Goldwasser RS. Extubation outcome after spontaneous breathing trials with T-tube or pressure support ventilation. The Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med. 1997 Aug;156(2 Pt 1):459-65. doi: 10.1164/ajrccm.156.2.9610109.

  PMID: 9279224 BACKGROUND

• Perren A, Domenighetti G, Mauri S, Genini F, Vizzardi N. Protocol-directed weaning from mechanical ventilation: clinical outcome in patients randomized for a 30-min or 120-min trial with pressure support ventilation. Intensive Care Med. 2002 Aug;28(8):1058-63. doi: 10.1007/s00134-002-1353-z. Epub 2002 Jul 13.

  PMID: 12185425 BACKGROUND

• Esteban A, Anzueto A, Frutos F, Alia I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguia C, Nightingale P, Arroliga AC, Tobin MJ; Mechanical Ventilation International Study Group. Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA. 2002 Jan 16;287(3):345-55. doi: 10.1001/jama.287.3.345.

  PMID: 11790214 BACKGROUND

• Esteban A, Anzueto A, Alia I, Gordo F, Apezteguia C, Palizas F, Cide D, Goldwaser R, Soto L, Bugedo G, Rodrigo C, Pimentel J, Raimondi G, Tobin MJ. How is mechanical ventilation employed in the intensive care unit? An international utilization review. Am J Respir Crit Care Med. 2000 May;161(5):1450-8. doi: 10.1164/ajrccm.161.5.9902018.

  PMID: 10806138 BACKGROUND

• Subira C, Hernandez G, Vazquez A, Rodriguez-Garcia R, Gonzalez-Castro A, Garcia C, Rubio O, Ventura L, Lopez A, de la Torre MC, Keough E, Arauzo V, Hermosa C, Sanchez C, Tizon A, Tenza E, Laborda C, Cabanes S, Lacueva V, Del Mar Fernandez M, Arnau A, Fernandez R. Effect of Pressure Support vs T-Piece Ventilation Strategies During Spontaneous Breathing Trials on Successful Extubation Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial. JAMA. 2019 Jun 11;321(22):2175-2182. doi: 10.1001/jama.2019.7234.

  PMID: 31184740 BACKGROUND

• Fernandez MM, Gonzalez-Castro A, Magret M, Bouza MT, Ibanez M, Garcia C, Balerdi B, Mas A, Arauzo V, Anon JM, Ruiz F, Ferreres J, Tomas R, Alabert M, Tizon AI, Altaba S, Llamas N, Fernandez R. Reconnection to mechanical ventilation for 1 h after a successful spontaneous breathing trial reduces reintubation in critically ill patients: a multicenter randomized controlled trial. Intensive Care Med. 2017 Nov;43(11):1660-1667. doi: 10.1007/s00134-017-4911-0. Epub 2017 Sep 22.

  PMID: 28936675 BACKGROUND

• Andreu M, Bertozzi M, Bezzi M, Borello S, Castro D, Giorgio VD, Aguirre M; ExtubAR group; ExtubAR group is composed by. Comparison of Two Extubation Techniques in Critically Ill Adult Subjects: The ExtubAR Randomized Clinical Trial. Respir Care. 2022 Jan;67(1):76-86. doi: 10.4187/respcare.09276. Epub 2021 Nov 3.

  PMID: 34732586 RESULT

• Soummer A, Perbet S, Brisson H, Arbelot C, Constantin JM, Lu Q, Rouby JJ; Lung Ultrasound Study Group. Ultrasound assessment of lung aeration loss during a successful weaning trial predicts postextubation distress*. Crit Care Med. 2012 Jul;40(7):2064-72. doi: 10.1097/CCM.0b013e31824e68ae.

  PMID: 22584759 RESULT

• Tenza-Lozano E, Llamas-Alvarez A, Jaimez-Navarro E, Fernandez-Sanchez J. Lung and diaphragm ultrasound as predictors of success in weaning from mechanical ventilation. Crit Ultrasound J. 2018 Jun 18;10(1):12. doi: 10.1186/s13089-018-0094-3.

  PMID: 29911284 RESULT

• Subira C, Rognoni G, Baquerizo H, Garcia C, Cabanes S, de la Torre M, Quevedo B, Pedros C, Tizon AI, Murillo N, Parro L, Eiras F, Rialp G, Altaba S, Gonzalez-Castro A, Pacheco AF, Bayoumi P, Gomez-Medrano N, Vallverdu I, Higon A, Navarro MD, Falcon A, Keough E, Arizo D, Martinez JF, Duran N, Rodriguez R, Popoviciu-Koborzan MR, Guerrero I, Concha P, Barral P, Batlle M, Cano S, Garcia-Castrillon S, Andorra X, Tua Y, Arnau A, Fernandez R. Effect of lung volume preservation during spontaneous breathing trial on successful extubation in patients receiving mechanical ventilation: protocol for a multicenter clinical trial. Trials. 2024 Jul 16;25(1):481. doi: 10.1186/s13063-024-08297-1.

  PMID: 39014430 DERIVED

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Rafael Fernandez, PhD

  Althaia Xarxa Assistencial de Manresa

  STUDY DIRECTOR

• Carlos Subira, PhD

  Althaia Xarxa Assitencial de Manresa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Model Details: Patients will be allocated to one of the two strategies: * Standard OR * Preserving Lung volume

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 2, 2022
• Study Start: January 15, 2023
• Primary Completion: August 13, 2024
• Study Completion: August 13, 2024
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)