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Effects of intraoperative PEEP on postoperative pulmonary complications in high-risk patients undergoing laparoscopic abdominal surgery: study protocol for a randomised controlled trial
  1. Zhen-feng Zhou1,
  2. Jun-biao Fang1,
  3. Hong-fa Wang1,
  4. Ying He1,
  5. Yong-jian Yu1,
  6. Qiong Xu1,
  7. Yun-fen Ge1,
  8. Miao-zun Zhang2,
  9. Shuang-fei Hu1
  1. 1Department of Anesthesiology, Zhejiang Provincial People,s Hospital (People,s Hospital of Hangzhou Medicine College), Hangzhou, China
  2. 2General Surgery, Ningbo Medical center Lihuili Hospital, Ningbo, China
  1. Correspondence to Dr Shuang-fei Hu; hushuangfei77{at}sina.com

Abstract

Introduction Postoperative pulmonary complications (PPCs), strongly associated with higher mortality risk, can develop in up to 58% of patients undergoing abdominal surgery. More and more evidence shows that the use of a lung-protective ventilation strategy has a lung protection effect in patients undergoing abdominal surgery, however, the role of positive end-expiratory pressure (PEEP) during the intraoperative period in preventing PPCs for laparoscopic surgery is not clearly defined.

Methods and analysis A total of 208 patients with a high risk of PPC, undergoing laparoscopic abdominal surgery, will be enrolled and randomised into a standard PEEP (6–8 cm H2O) group and a low PEEP (≤2 cm H2O) group. Both groups will receive a fraction of inspired oxygen of 0.50 and a tidal volume of 8 mL/kg ideal body weight (IBW). Standard perioperative fluid management and analgesic treatments are applied in both groups. The primary end point is PPC within 7 days after surgery. Secondary end points are the modified Clinical Pulmonary Infection Score, postoperative extrapulmonary complications, postoperative surgical complications, intensive care unit length of stay, hospital length of stay, 30-day mortality.

Ethics and dissemination The study was approved by the Ethics Committee of Zhejiang Provincial People’s Hospital (People’s Hospital of Hangzhou Medicine College) (registration number KY2018026) on 22 October 2018. The first participant was recruited on 15 April 2019 and the estimated completion date of the study is October 2021. The results of this trial will be submitted to a peer-reviewed journal.

Trial registration number http://www.chictr.org.cn, ID: ChiCTR1800019865. Registered on 2 December 2018; preresults.

  • positive end-expiratory pressure
  • postoperative pulmonary complications
  • laparoscopic surgery

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors Z-fZ and S-fH designed the study protocol and wrote the paper. H-fW and M-zZ designed the statistical method. The work of patient recruitment and data collecting will be done by J-bF, Y-jY, QX, YH and Y-fG. S-fH is the study director and J-bF is the principal investigator of this study. All authors have read the manuscript and approved the final paper submitted.

  • Funding This study was supported by the Health Commission of Zhejiang Province (No.2020KY032).

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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