Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
26/09/2016
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 Bernadette Ewah

ORCID ID

Contact details

Epsom and St Helier NHS Trust
Epsom General Hospital
Dorking Road
Epsom
Surrey
KT18 7EG
United Kingdom
+44 (0)1372 7355270
bewah99@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0112112997

Study information

Scientific title

Tidal Volume - Cytokine levels trial in anaesthetised patients undergoing positive pressure ventilation

Acronym

Study hypothesis

What tidal volume is beneficial for artificial ventilation during surgery?

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Surgery: Ventilation

Intervention

Patients randomly divided into two groups. One group is ventilated with a standard tidal volume of 10 ml/kg. The second group is ventilated with 6 ml/kg. Cytokine levels in bronchial aspirate and blood are measured.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Cytokine levels.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/2002

Overall trial end date

01/02/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

50

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/02/2002

Recruitment end date

01/02/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Epsom and St Helier NHS Trust
Surrey
KT18 7EG
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

Epsom and St Helier University Hospitals NHS Trust (UK)

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

Publication citations

Additional files

Editorial Notes

26/09/2016: No publications found, verifying study status with principal investigator