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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Prophylactic penehyclidine inhalation for prevention of postoperative pulmonary complications in high-risk patients: study protocol of a randomized controlled trial

Authors: Ting Yan, Xin-Quan Liang, Tong Wang, Wei-Ou Li, Hui-Juan Li, Sai-Nan Zhu, Dong-Xin Wang

Published in: Trials | Issue 1/2017

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Abstract

Background

Postoperative pulmonary complications (PPCs) are major causes of morbidity, mortality, and prolonged hospital stay in patients after surgery. Using effective strategies to prevent its occurrence is essential to improve outcome. However, despite various efforts, the incidence of PPCs remains elevated in high-risk patients. Anticholinergic inhalation is used to reduce high airway resistance and improve pulmonary function; it may be helpful to decrease the risk of PPCs. Penehyclidine is a long-acting anticholinergic agent which selectively blocks M1 and M3 receptors. We hypothesize that, in high-risk patients, prophylactic penehyclidine inhalation may decrease the incidence of PPCs.

Methods

This is a randomized, double-blind, placebo-controlled trial with two parallel arms. A total of 864 patients at high risk of PPCs will be enrolled and randomized to receive prophylactic inhalation of either penehyclidine or placebo (water for injection). Study drug inhalation will be administered from the night (7 pm) before surgery until the second day after surgery, in an interval of every 12 hours. The primary outcome is the incidence of PPCs within 30 days after surgery. Secondary outcomes include the time to onset of PPCs (from end of surgery to first diagnosis of PPCs), the number of PPCs (indicates the number of diagnosed individual PPCs), the incidence of postoperative extrapulmonary complications, the length of stay in hospital after surgery, and the 30-day all-cause mortality.

Discussion

Results of the present study will provide evidence to guide clinical practice in using prophylactic inhalation of an anticholinergic to prevent PPCs in high-risk patients.

Trial registration

The study was registered prospectively in Chinese Clinical Trial Registry (www.​chictr.​org.​cn, ChiCTR-IPC-15006603) on 14 May 2015 and retrospectively in ClinicalTrials.gov (NCT02644876) on 30 December 2015.
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Metadata
Title
Prophylactic penehyclidine inhalation for prevention of postoperative pulmonary complications in high-risk patients: study protocol of a randomized controlled trial
Authors
Ting Yan
Xin-Quan Liang
Tong Wang
Wei-Ou Li
Hui-Juan Li
Sai-Nan Zhu
Dong-Xin Wang
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2315-7

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