Effect of lung volume preservation during spontaneous breathing trial on successful extubation in patients receiving mechanical ventilation: protocol for a multicenter clinical trial

• Published in: Current controlled trials in cardiovascular medicine 2024-07, Vol.25 (1), p.481-12, Article 481
• Main Authors: Subirà, Carles, Rognoni, Gina, Baquerizo, Herbert, García, Carolina, Cabañes, Sara, de la Torre, Maria, Quevedo, Beatriz, Pedrós, Cristina, Tizón, Ana I, Murillo, Natalia, Parro, Laura, Eiras, Fernando, Rialp, Gemma, Altaba, Susana, González-Castro, Alejandro, Pacheco, Andrés F, Bayoumi, Pablo, Gómez-Medrano, Norma, Vallverdú, Imma, Higón, Áurea, Navarro, María D, Falcón, Alirio, Keough, Elena, Arizo, David, Martínez, Juan F, Durán, Núria, Rodríguez, Raquel, Popoviciu-Koborzan, Melinda R, Guerrero, Isabel, Concha, Pablo, Barral, Patricia, Batlle, Montserrat, Cano, Sílvia, Garcia-Castrillon, Silvia, Andorrà, Xavier, Tua, Yenifher, Arnau, Anna, Fernández, Rafael
• Format: Article
• Language: English
• Subjects: Acidosis; Adult; Aged; Airway Extubation; Anesthesia; Clinical trials; Collaboration; Equivalence Trials as Topic; Extubation; Female; Hospitals; Humans; Informed consent; Intensive care; Intervention; Lung - diagnostic imaging; Lung - physiopathology; Lung ultrasound; Lung Volume Measurements; Male; Mechanical ventilation; Middle Aged; Multicenter Studies as Topic; Ostomy; Patients; Positive-Pressure Respiration - adverse effects; Positive-Pressure Respiration - methods; Randomized Controlled Trials as Topic; Respiration, Artificial - methods; Spontaneous breathing trial; Study Protocol; Suction - methods; Suctioning; Time Factors; Treatment Outcome; Ultrasonic imaging; Ultrasonography; Ventilator Weaning - methods; Ventilators; Weaning
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-024-08297-1

In standard weaning from mechanical ventilation, a successful spontaneous breathing test (SBT) consisting of 30 min 8 cmH O pressure-support ventilation (PSV8) without positive end-expiratory pressure (PEEP) is followed by extubation with continuous suctioning; however, these practices might promote derecruitment. Evidence supports the feasibility and safety of extubation without suctioning. Ultrasound can assess lung aeration and respiratory muscles. We hypothesize that weaning aiming to preserve lung volume can yield higher rates of successful extubation. This multicenter superiority trial will randomly assign eligible patients to receive either standard weaning [SBT: 30-min PSV8 without PEEP followed by extubation with continuous suctioning] or lung-volume-preservation weaning [SBT: 30-min PSV8 + 5 cmH O PEEP followed by extubation with positive pressure without suctioning]. We will compare the rates of successful extubation and reintubation, ICU and hospital stays, and ultrasound measurements of the volume of aerated lung (modified lung ultrasound score), diaphragm and intercostal muscle thickness, and thickening fraction before and after successful or failed SBT. Patients will be followed for 90 days after randomization. We aim to recruit a large sample of representative patients (N = 1600). Our study cannot elucidate the specific effects of PEEP during SBT and of positive pressure during extubation; the results will show the joint effects derived from the synergy of these two factors. Although universal ultrasound monitoring of lungs, diaphragm, and intercostal muscles throughout weaning is unfeasible, if derecruitment is a major cause of weaning failure, ultrasound may help clinicians decide about extubation in high-risk and borderline patients. The Research Ethics Committee (CEIm) of the Fundació Unió Catalana d'Hospitals approved the study (CEI 22/67 and 23/26). Registered at ClinicalTrials.gov in August 2023. Identifier: NCT05526053.