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 |
| Protocol serial number | N0084186834 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funders | The North and South Bank Research and Development Consortium, Hull and East Yorkshire Hospital Trust |
- 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
Scientific
Anaesthetics Dept
Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom
| Phone | +44 627047 |
|---|---|
| abc@email.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A study to compare intubation conditions using the CTrach versus the Bonfils rigid fibrescope and CTrach intubating Laryngeal mask airway |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Which of the two devices will be successful and quicker in placing the device in throat and placing the tube in windpipe. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 01/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 132 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 29/09/2006 |
| Date of final enrolment | 01/10/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom
HU3 2JZ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
