Table 1

Trial registration data set for NIPPER PLUS trial

Data category	Information
Primary registry and trial identifying number	Australian New Zealand Clinical Trials Registry number: ACTRN12617000269336
Date of registration in primary registry	22/02/2017
Secondary identifying numbers	n/a
Trial protocol version	This is version 2 of the protocol and was enacted on February 2017.
Source of monetary or material support	Clifford Craig Foundation ($A80 000)
Contact for public queries	JL: jane.lockstone@ths.tas.gov.au
Contact for scientific queries	JL: jane.lockstone@ths.tas.gov.au
Public title	Does early postoperative non-invasive ventilation (NIV) prevent chest infections following high-risk elective abdominal surgery
Scientific title	NIPPER-PLUS trial – Non-Invasive Positive airway Pressure therapy to Reduce Postoperative Lung Complications following Upper abdominal Surgery: a single centre pilot randomised control trial
Countries of recruitment	Australia
Health condition(s) or problem(s) studied Intervention(s)	Pulmonary complications following high-risk elective upper abdominal surgery. Active comparator: physiotherapy-led postoperative NIV therapy. Placebo comparator: high-flow nasal prong oxygen therapy.
Key inclusion and exclusion criteria	Ages edible for study: ≥18 years. Sexes eligible for study: both. Accepts health volunteers: no. Inclusion criteria: all adults undergoing high-risk elective open and/or advanced hand-assisted laparoscopic abdominal surgery. Exclusion criteria: (1) any absolute contraindications for NIV in the period following surgery prior to the first NIV session; (2) oesophageal surgery; (3) obstructive sleep apnoea requiring continuous positive airway pressure overnight; (4) extreme claustrophobia; (5) not able to understand verbal instructions in English; (6) do not have capacity to give consent themselves; (7) a current hospital patient for a separate episode of care; and (8) requiring organ transplant.
Study type	Type: investigator initiated, interventional, non-pharmacological, pilot study. Allocation: concealed randomisation. Intervention model: parallel assignment. Masking: assessor blinding. Primary purpose: prevention. Phase: phase 2.
Date of first enrolment	23/02/2017
Target sample size	Minimum 130
Recruitment status	Recruiting
Primary Outcome	Postoperative pulmonary complication during the first 14 postoperative days.
Key secondary outcomes	Recruitment ability, physiotherapy-led NIV and high-flow nasal oxygen therapy protocol adherence, safety of NIV therapy, associated costs of high-flow nasal oxygen therapy and a physiotherapy-led NIV service following upper abdominal surgery. In addition, this study will explore effects on incidence of pneumonia; intensive care unit (ICU) and hospital length of hospital; ICU readmission rates; incidence of reintubation; in-hospital, 30-day and 12-month all-cause mortality; and health related quality of life.