Condition category
Surgery
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
02/09/2015
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 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

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

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

Publication citations

Additional files

Editorial Notes