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| [ Print-friendly version ] |
| A study to compare intubation conditions using the CTrach versus the Bonfils rigid fibrescope and CTrach intubating Laryngeal mask airway |
| ISRCTN | ISRCTN84583320 |
| ClinicalTrials.gov identifier | |
| Public title | A study to compare intubation conditions using the CTrach versus the Bonfils rigid fibrescope and CTrach intubating Laryngeal mask airway |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | N0084186834 |
| 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 |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Surgery: Intubation |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 29/09/2006 |
| Anticipated end date | 01/10/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 132 |
| Interventions |
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 |
| 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. |
| 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. |
| Sources of funding |
The North and South Bank Research and Development Consortium
Hull and East Yorkshire Hospital Trust |
| Trial website | |
| Publications | |
| Contact name | Dr PS Venkatesan |
| Address |
Anaesthetics Dept
Hull Royal Infirmary |
| City/town | Hull |
| Zip/Postcode | HU3 2JZ |
| Country | United Kingdom |
| Tel | +44 627047 |
| Fax | +44 |
| venkatesanps@hotmail.com | |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Address | The Department of Health, Richmond House, 79 Whitehall |
| City/town | London |
| Zip/Postcode | SW1A 2NL |
| Country | United Kingdom |
| Tel | +44 (0)20 7307 2622 |
| Fax | +44 |
| dhmail@doh.gsi.org.uk | |
| Sponsor website: | http://www.dh.gov.uk/Home/fs/en |
| Date applied | 28/09/2007 |
| Last edited | 06/11/2007 |
| Date ISRCTN assigned | 28/09/2007 |
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