Effectiveness and pulmonary complications of perioperative laryngeal mask airway used in elderly patients (POLMA-EP trial): study protocol for a randomized controlled trial

Ling Zhu, Xiao Shi, Suqing Yin, Jiemin Yin, Ziyu Zhu, Xiong Gao, Yingfu Jiao, Weifeng Yu, Liqun Yang, Ling Zhu, Xiao Shi, Suqing Yin, Jiemin Yin, Ziyu Zhu, Xiong Gao, Yingfu Jiao, Weifeng Yu, Liqun Yang

Abstract

Background: With the increasing amount of geriatric surgery, it has become a great challenge for anesthesiologists to reduce the incidence of postoperative pulmonary complications (PPCs). The two most popular airway management methods, laryngeal mask airway (LMA) and endotracheal intubation (ETI), both have their unique advantages in specific clinical settings. For the purpose of helping clinicians make better decisions on airway management during geriatric surgery, we designed this multi-center clinical trial to compare the influence of LMA and ETI on PPCs.

Methods/design: In this multi-center, randomized, parallel clinical trial, a total of 6000 elderly patients, aged ≥ 70 years, with an American Society of Anesthesiologists classification level of 1-2 and a body mass index ≤ 35 kg/m2, undergoing elective surgery will be enrolled and randomized into the LMA or the ETI group. Both groups will receive usual perioperative care except for the adoption of LMA/ETI. Primary outcomes are the occurrence of PPCs and patients' perioperative mortality rates. Ease of intubation, anesthetics consumption, treatment for PPCs, duration of surgery, anesthesia recovery time and performance, time of PPC onset, postanesthesia care unit stay, intensive care unit admission and stay, in-hospital days, re-admission rates, hospitalization cost, and patients' satisfactory scores will be secondary outcomes. Follow-up will be conducted through phone-call visits until 12 weeks after discharge.

Discussion: This trial will assess the possible benefits or disadvantages of perioperative LMA use in elderly patients compared with ETI regarding the occurrence of PPCs and clinical prognosis. We expect that this trial will also add to the current understanding of PPCs in geriatric populations and contribute to the international recommendations of geriatric surgery management.

Trial registration: ClinicalTrials.gov, NCT02240901 . Registered on 16 September 2014.

Keywords: Elderly patient; Laryngeal mask airway; Postoperative complication; Ventilation mode.

Conflict of interest statement

Ethics approval and consent to participate

The study has been approved by the Ethics Committee of Ren Ji Hospital on 27 April 2017. Before inclusion, trained anesthesiologists will explain the trial information to patients thoroughly, and patients are given at least 24 h before signing informed consents. Participants are free to withdraw at any time. The investigators’ contact information is given to the participants should they have any questions.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study flow diagram
Fig. 2
Fig. 2
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure for the POLMA-EP trial

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