Pulmonary Complications after Airway Management with Laryngeal Masks or Endotracheal Intubation in Geriatric Patients Having Elective Surgery: The POLMA-EP Multi-Centre Randomized Trial

Abstract

Background: Postoperative pulmonary complications are serious, and especially common in geriatric surgical patients. Laryngeal mask airways and endotracheal intubation and are the two most common airway approaches for patients who require general anaesthesia. Laryngeal mask airways are less invasive than intubation and easier to insert, but do not protect the airway from aspiration. Which approach is preferable remains unknown. We therefore tested the primary hypothesis that a composite of in-hospital postoperative pulmonary complications is less common with laryngeal mask airways than after endotracheal intubation in patients having elective noncardiac surgery with general anaesthesia and mechanical ventilation. Methods: We enrolled patients ≥ 70 years old who required general anaesthesia for elective noncardiac surgery in 17 Chinese clinical centres. Patients were randomly assigned to airway management with endotracheal intubation or laryngeal masks. The primary outcome was the incidence of in-hospital postoperative pulmonary complications. Secondary outcomes included pulmonary complication grades and diagnoses, mortality, number of insertion attempts, treatments for pulmonary complications, time in the post-anaesthesia care unit, need for intensive care, duration of hospitalization, positive blood/sputum cultures, and hospital cost. Findings: Among 2,900 randomized patients, the median age was 74 years, 49% were women, and 39% had abdominal surgery. Pulmonary complications occurred in 342 of 1,364 evaluable patients (25·1%) assigned to endotracheal intubation and 270 of 1387 evaluable patients (19·5%) assigned to a laryngeal mask airway: absolute difference, -5·6% [95%CI, -8·7% to -2·5%]; risk ratio, 0·78 [95% CI, 0·67 to 0·89], P<0·001. There were no significant between-group differences in pneumonia, atelectasis, pleural effusion, systemic inflammatory response syndrome, sepsis, acute lung injury/acute respiratory distress syndrome.InterpretationAmong geriatric patients having elective surgery with general anaesthesia and intraoperative mechanical ventilation, there were fewer pulmonary complications with laryngeal mask airways than after endotracheal intubation. Laryngeal mask airways may be preferable in many patients. Trial Registration: ClinicalTrials.gov Identifier: NCT02240901. Funding: The Science and Technology Commission of Shanghai Municipality, the Shanghai Hospital Development Center, Investigative Doctor Program (2017) of Shanghai Jiao Tong University School of Medicine, the Shanghai Municipal Key Clinical Specialty, the Innovation Program of Shanghai Municipal Education Commission. Declaration of Interest: All authors declare no competing interests. Ethical Approval: Our trial was conducted in 17 Chinese hospitals (Supplement 1) from August 2016 to April 2020. The study protocol was approved by ethics committees of all participating centres. Written informed consent was obtained from participating patients.