Open Lung Protective Extubation Following General Anesthesia

Condition(s) studied

Investigational drug(s) / intervention(s)

Protective "open-lung" extubation: Emergence using 50% FiO2, semi-sitting position with pressure support ventilation and preserved PEEP

Conventional extubation: Emergence using 100% FiO2, dorsal decubitus position with assistance or manual bag ventilation without PEEP

Study summary

Perioperative respiratory complications are a major source of morbidity and mortality. Postoperative atelectasis plays a central role in their development. Protective "open lung" mechanical ventilation aims to minimize the occurrence of atelectasis during the perioperative period. Randomized controlled studies have been performed comparing various "open lung" ventilation protocols, but these studies report varying and conflicting effects. The interpretation of these studies is complicated by the absence of imagery supporting the pulmonary impact associated with the use of different ventilation strategies. Imaging studies suggest that the gain in pulmonary gas content in "open lung" ventilation regimens disappears within minutes after the extubation. Thus, the potential benefits of open-lung ventilation appear to be lost if, at the time of extubation, no measures are used to keep the lungs well aerated. Recent expert recommendations on good mechanical ventilation practices in the operating room conclude that there is actually no quality study on extubation.

Extubation is a very common practice for anesthesiologists as part of their daily clinical practice. It is therefore imperative to generate evidence on good clinical practice during anesthetic emergence in order to potentially identify an effective extubation strategy to reduce postoperative pulmonary complications.

Eligibility

Primary outcome measure(s)

• Average weekly patient recruitment rate — Every week. At the end of the study (average 9 months) at the study level.
  Achieve a weekly patient recruitment rate of 2 patients per week per center
• Protocol adherence rate — At the end of surgery for individual assessments. At the end of the study (average 9 months) at the study level.
  Assess adherence to a protocol during emergence from anesthesia, monitoring four criteria (proper positioning (dorsal decubitus or semi-sitting position), correct FiO2 (100% or 50%), appropriate ventilatory mode (manual or pressure support ventilation), and proper end-expiratory pressure (zero or preserved end-expiratory pressure), and noting deviations, with adherence defined as successful performance of all criteria during extubation.
• Postoperative pulmonary complications outcome completion rate — At postoperative day 7 for individual assessments. At the end of the study (average 9 months) at the study level.
  Postoperative pulmonary complications are defined as a composite endpoint that includes atelectasis, pneumonia, acute respiratory distress syndrome, and pulmonary aspiration, according to the StEP-COMPAC definition.

Trial sites (5)

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