Contact information
Type
Scientific
Primary contact
Dr PS Venkatesan
ORCID ID
Contact details
Anaesthetics Dept
Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom
+44 627047
abc@email.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0084186834
Study information
Scientific title
A study to compare intubation conditions using the CTrach versus the Bonfils rigid fibrescope and CTrach intubating Laryngeal mask airway
Acronym
Study hypothesis
Compare the airway management devices 'Bonfils' and 'CTrach' with respect to:
1. Time it takes to be placed it successfully in the throat
2. How quickly it helps to successfully place tube in windpipe for patients undergoing general anaesthesia for their operation
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
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Surgery: Intubation
Intervention
Patients are randomly selected to belong to either Bonfils group or CTrach group.
Procedure
In order to ensure that the conditions under which the study is conducted remains the same in all subjects, the following procedure will be followed at induction by the team managing the patient:
1. Pre-oxygenation for 3 minutes
2. Intravenous administration of Fentanyl 1-2 milligrams per kilogram patient weight to all patients
3. Either of two methods of induction of anesthesia with target controlled infusion (TCI) of Propofol to target 3-7 milligrams per ml, then maintenance target (TCI) 2.5-4 micrograms per ml with 50% oxygen and 50% air, or intravenous induction of bolus dose of propofol 2-3mg/ml and then anaesthesia maintained with 50% oxygen, 50% air and sevoflurane
4. Muscle relaxation with intravenous administration of Atracurium 0.5 mg/kg to all patients to aim for T0F with 1/4 for adequate muscle relaxation
Following oxygenation, adequate manual ventilation and assessment for adequate level of anaesthesia and relaxation, the following procedure will then follow:
1. Direct laryngoscopy and airway grading by experienced anaesthetist using Macintosh blade (in absence of anaesthetist to use trial device), and using the modified Cormack and Lehane laryngoscopy grading
2. Call back anaesthetist to insert trial device
3. Pick envelope to identify device
4. Start stop clock at beginning of insertion of device and stop it at time capnograph trace is seen
5. Device insertion after appropriate positioning of subjects head
Parameters to be monitored and recorded:
1. Ctrach group
2. Bonfils fibrescope group
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Which of the two devices will be successful and quicker in placing the device in throat and placing the tube in windpipe.
Secondary outcome measures
To compare the easiness and quality of the windpipe view obtained, to compare performance of consultants and registrars, to find out any relation between conventional scope grading and successful placement of tube in windpipe with both devices.
Overall trial start date
29/09/2006
Overall trial end date
01/10/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age over 16 years
2. Elective surgery requiring endotracheal intubation
3. ASA status 1-3
4. Airway Mallampati grade 1-3
5. Competency to give informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
132
Participant exclusion criteria
1. Morbid obesity (BMI > 35)
2. Pregnancy
3. Emergency surgery or inadequate starvation period
4. Gastro-oesophageal starvation period
5. Gastro-oesophageal reflux or hiatus hernia
6. Severe respiratory disease
7. Mental incapacity
8. Coagulation abnormalities
9. Oral surgery
Recruitment start date
29/09/2006
Recruitment end date
01/10/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 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
The North and South Bank Research and Development Consortium
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Hull and East Yorkshire Hospital Trust
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