Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
01/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stuart Greenhill

ORCID ID

Contact details

Department of Anaesthesia
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 07766432470
greenhill@doctors.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436176302

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Difference between intra-operative and post-operative alveolar to arterial oxygen difference (A-aDO2)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

27/02/2006

Overall trial end date

27/02/2007

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

44 (22 per group) (added 01/04/10; see publication)

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

27/02/2006

Recruitment end date

27/02/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Anaesthesia
Leeds
LS1 3EX
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Leeds Teaching Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20354010

Publication citations

  1. Results

    Lumb AB, Greenhill SJ, Simpson MP, Stewart J, Lung recruitment and positive airway pressure before extubation does not improve oxygenation in the post-anaesthesia care unit: a randomized clinical trial., Br J Anaesth, 2010, 104, 5, 643-647, doi: 10.1093/bja/aeq080.

Additional files

Editorial Notes