NCT01314287

Brief Summary

General anaesthesia causes small areas of lung to collapse (referred to as atelectasis) and many strategies are used to prevent or reverse this, but these strategies only temporarily improve lung function and do not persist into the post anaesthesia care unit (PACU) where atelectasis may still be present. One possible explanation for this is that coughing occurring at the end of the anaesthesic may cause atelectasis to occur. Over 70% of patients cough when their breathing tube is removed as they emerge from the anaesthetic, and our hypothesis is that the presence of the breathing tube prevents a normal cough from occurring and may worsen atelectasis. This study will use alveolar-arterial oxygen difference (AaDO2)as a measure of how well the lungs are oxygenating the blood. This will be measured 30 minutes before the end of the anaesthetic as a control measure of the patient's lung function, and again 60 minutes after the patient has woken up, and the change compared with the amount of coughing observed as the patient emerges from the anaesthetic.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 14, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

April 11, 2014

Status Verified

April 1, 2014

Enrollment Period

2.5 years

First QC Date

March 11, 2011

Last Update Submit

April 10, 2014

Conditions

Keywords

Anaesthesiapulmonary complicationsAtelectasis

Outcome Measures

Primary Outcomes (1)

  • Change in oxygenation before and after emergence from general anaesthesia

    Change between intraoperative and postoperative AaDO2 for each patient in relation to the amount of coughing observed on emergence from anaesthesia.

    2 hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study subjects will be adult patients undergoing routine operations which are expected to last longer than 45 minutes.

You may qualify if:

  • Patients will be selected who require, as part of their normal clinical anaesthetic care, a breathing tube in their lungs and a small plastic tube (catheter) placed in an artery for monitoring and blood sampling

You may not qualify if:

  • Refusal or inability to provide written, informed consent
  • Respiratory disease which is severe enough to prevent the safe use of the oxygen levels required for this study
  • A expectation that the patient will require their breathing to be supported artificially after the operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St James's University Hospital

Leeds, West Yorkshire, LS9 7TF, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Andrew B Lumb, MB BS FRCA

    Leeds Teaching Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Anaesthetist

Study Record Dates

First Submitted

March 11, 2011

First Posted

March 14, 2011

Study Start

January 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

April 11, 2014

Record last verified: 2014-04

Locations