Videolaryngoscopy results in less forces exerted on the upper teeth during intubation compared to direct laryngoscopy
| ISRCTN | ISRCTN28037056 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28037056 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/09/2010
- Registration date
- 29/10/2010
- Last edited
- 29/10/2010
- 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
Miss Barbe Pieters
Scientific
Scientific
P. Debyelaan 25
Maastricht
6229 HX
Netherlands
Study information
| Study design | Single centre randomised controlled cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Videolaryngoscopy results in less forces exerted on the upper teeth during intubation compared to direct laryngoscopy: a single centre randomised controlled cross-over study |
| Study objectives | Three videolaryngoscopes (McGrath, C-Mac and Glidescope Cobalt) exert reduced forces on both upper and lower teeth, compared to a classic Macintosh laryngoscope blade. |
| Ethics approval(s) | Catharina Hospital Eindhoven (Netherlands) |
| Health condition(s) or problem(s) studied | Intubation technique |
| Intervention | After three minutes of oxygen administration via facemask, intravenous (iv) induction of general anesthesia (1 µg/kg fentanyl, 3 mg/kg propofol and 0.7 mg/kg rocuronium) the following interventions will be performed: Direct laryngoscopy: 1. Macintosh classic laryngoscope (blade III) Indirect laryngoscopy with one of three indirect videolaryngoscopes: 1. McGrath (Aircraft Medical, Edinburgh, UK) 2. C-MAC (Karl Storz, Tuttlingen, Germany) 3. Glidescope Cobalt (Verathon, Bothell, WA, USA) Intubation: endotracheal tube 7.5 mm (female) or 8.0 mm (male). After two unsuccessful attempts a stylet will be inserted into the endotracheal tube. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Differences between direct and indirect laryngoscopies with respect to the frequency with which forces are applied on the upper and lower teeth. The measurement of forces will be performed with Flexiforce (r) sensors (A201-25, Tekscan, MA) fixed to the blade of the laryngoscope at the possible area of contact with the teeth. |
| Secondary outcome measures | For the cases in which forces are being applied, differs the magnitude of forces between the laryngoscopes? |
| Overall study start date | 01/11/2010 |
| Completion date | 01/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 |
| Key inclusion criteria | 1. American Society of Anaesthesiologists (ASA) grade I - II 2. Normal airway 3. Undergoing a surgical intervention for which endotracheal intubation is indicated 4. Aged 18 years or above, either sex |
| Key exclusion criteria | 1. Younger than 18 years 2. Patients requiring more than blade size III of laryngoscope 3. Patients with pre-operative predictors of a difficult airway (Mallampati score IV, thyromental distance less than 65 mm, interincisor/interdental distance less than 35 mm) 4. Patients with inadequate neck movement 5. ASA III - IV 6. Patients requiring surgery of the face and throat |
| Date of first enrolment | 01/11/2010 |
| Date of final enrolment | 01/01/2011 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
P. Debyelaan 25
Maastricht
6229 HX
Netherlands
6229 HX
Netherlands
Sponsor information
Catharina Hospital Eindhoven (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Anesthesiology, ICU and Pain Therapy
Michelangelolaan 2
Eindhoven
5623 EJ
Netherlands
"ROR" |
https://ror.org/01qavk531 |
|---|
Funders
Funder type
Hospital/treatment centre
Catharina Hospital Eindhoven (Netherlands) - Department of Anesthesiology, ICU and Pain Therapy
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
