A study to compare intubation conditions using the CTrach versus the Bonfils rigid fibrescope and CTrach intubating Laryngeal mask airway

ISRCTN ISRCTN84583320
DOI https://doi.org/10.1186/ISRCTN84583320
Secondary identifying numbers N0084186834
Submission date
28/09/2007
Registration date
28/09/2007
Last edited
02/09/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr PS Venkatesan
Scientific

Anaesthetics Dept
Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom

Phone +44 627047
Email abc@email.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA study to compare intubation conditions using the CTrach versus the Bonfils rigid fibrescope and CTrach intubating Laryngeal mask airway
Study objectivesCompare 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Intubation
InterventionPatients 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 typeProcedure/Surgery
Primary outcome measureWhich of the two devices will be successful and quicker in placing the device in throat and placing the tube in windpipe.
Secondary outcome measuresTo 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 study start date29/09/2006
Completion date01/10/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants132
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment29/09/2006
Date of final enrolment01/10/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

The North and South Bank Research and Development Consortium

No information available

Hull and East Yorkshire Hospital Trust

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan