Non-Invasive Positive airway Pressure thErapy to Reduce Postoperative Lung complications following Upper abdominal Surgery (NIPPER PLUS): protocol for a single-centre, pilot, randomised controlled trial

Abstract

IntroductionPostoperative pulmonary complications (PPCs) are a common serious complication following upper abdominal surgery leading to significant consequences including increased mortality, hospital costs and prolonged hospitalisation. The primary objective of this study is to detect whether there is a possible signal towards PPC reduction with the use of additional intermittent non-invasive ventilation (NIV) compared with continuous high-flow nasal oxygen therapy alone following high-risk elective upper abdominal surgery. Secondary objectives are to measure feasibility of: (1) trial conduct and design and (2) physiotherapy-led NIV and a high-flow nasal oxygen therapy protocol, safety of NIV and to provide preliminary costs of care information of NIV and high-flow nasal oxygen therapy.Methods and analysisThis is a single-centre, parallel group, assessor blinded, pilot, randomised trial, with 130 high-risk upper abdominal surgery patients randomly assigned via concealed allocation to either (1) usual care of continuous high-flow nasal oxygen therapy for 48 hours following extubation or (2) usual care plus five additional 30 min physiotherapy-led NIV sessions within the first two postoperative days. Both groups receive standardised preoperative physiotherapy and postoperative early ambulation. No additional respiratory physiotherapy is provided to either group. Outcome measures will assess incidence of PPC within the first 14 postoperative days, recruitment ability, physiotherapy-led NIV and high-flow nasal oxygen therapy protocol adherence, adverse events relating to NIV delivery and costs of providing a physiotherapy-led NIV and a high-flow nasal oxygen therapy service following upper abdominal surgery.Ethics and disseminationEthics approval has been obtained from the relevant institution and results will be published to inform future multicentre trials.Trial registration numberACTRN12617000269336; Pre-results.

Validity and Utility Testing of a Criteria‐led Discharge Checklist to Determine Post‐operative Recovery after Abdominal Surgery: an International Multicentre Prospective Cohort Trial

“…From June 2013 to July 2018, 1111 patients were recruited within four clinical trials at five sites and two countries [14][15][16][17]. Following removal of 40 cases without CLD data, 1071 (96%) patients were included for analysis (Fig.…”

“…All trials had ethical approval and were prospectively registered. Detailed data collection methods and trial protocols are published elsewhere [14][15][16][17]. A synopsis of trial design, participant eligibility, and interventions are provided in Online Resource 1.…”

PHYSIO+++: protocol for a pilot randomised controlled trial assessing the feasibility of physiotherapist-led non-invasive ventilation for patients with hypoxaemia following abdominal surgery

“…Number of adverse or serious adverse events per treatment and group, occurring during or within 15 min of a treatment session and attributable to trial treatments. Defined in line with those described in previous trials of similar populations and treatments 30…”

Intensive physical therapy after emergency laparotomy: Pilot phase of the Incidence of Complications following Emergency Abdominal surgery Get Exercising randomized controlled trial

“…Following the standardized initial physical therapy session, control group participants were provided with once-daily assisted ambulation with a physical therapist or a therapy assistant working under the direct supervision of a physical therapist. Assisted ambulation was delivered using a protocol used previously in elective abdominal surgery [24][25][26][27] (Fig. 1).…”