Prospective randomised study of the influence of a lung recruitment strategy on oxygenation in the post-anaesthetic care unit (PACU)

ISRCTN	ISRCTN32464251
DOI	https://doi.org/10.1186/ISRCTN32464251
Protocol serial number	N0436176302
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funders	Leeds Teaching Hospitals NHS Trust (UK), NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Stuart Greenhill
Scientific

Department of Anaesthesia
Great George Street
Leeds
LS1 3EX
United Kingdom

Phone	+44 07766432470
Email	greenhill@doctors.org.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	The aim of the study is to investigate whether lung recruitment manoeuvres performed near the end of surgery can have beneficial effects on oxygenation that persist into the early postoperative period.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Anaesthesia
Intervention	Added 01/04/10 (see publication for further details): Adult patients undergoing elective surgery requiring tracheal intubation and an arterial catheter were randomized to receive: 1. Lung recruitment manoeuvre of 40 cm H2O for 15 s, 30 min before the end of anaesthesia, followed by 10 cm H2O of PEEP and then 10 cm H2O of CPAP from return of spontaneous breathing until extubation 2. No lung recruitment manoeuvre, ≤5 cm H2O PEEP, and no CPAP. Arterial blood gases taken at randomization and 1 h after extubation.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Difference between intra-operative and post-operative alveolar to arterial oxygen difference (A-aDO2)
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	27/02/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	44
Key inclusion criteria	Elective adult patients (lower age limit 18 years, no upper age limit) undergoing operative procedures lasting longer than 45 minutes requiring tracheal intubation muscle relaxation and the insertion of an arterial catheter on clinical grounds who will postoperatively be admitted to the post anaesthetic care unit.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	27/02/2006
Date of final enrolment	27/02/2007

Department of Anaesthesia

Leeds
LS1 3EX
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2010		Yes	No