Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0453168841
Study information
Scientific title
Acronym
Study hypothesis
This study aims to find out whether the low rate and high rate of CO2 insufflation at the commencement of laparoscopic surgery have different effects on cardiac function.
Ethics approval
Not provided at time of registration
Study design
Randomised comparative study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Surgery: Laparoscopy
Intervention
The study involves insufflating the abdomen with gas at either a low rate or high rate and evaluating its impact on the efficacy of the heart pump and on the hormones released during surgery. It will be a randomised clinical study involving 2 groups (CO2 insufflation at 1 l/1min & CO2 insufflation of 18 l/min)
Intervention type
Drug
Phase
Not Specified
Drug names
CO2
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
19/07/2005
Overall trial end date
30/12/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Consenting adult patients aged 16-80 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
19/07/2005
Recruitment end date
30/12/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRI Central Manchester & Manchester Children's University Hospitals
Manchester
M13 9WL
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
Funders
Funder type
Government
Funder name
Central Manchester and Manchester Children's University Hospitals NHS Trust (UK) - Trust Endowment,
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