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
Protocol serial number	N/A
Sponsor	Catharina Hospital Eindhoven (Netherlands)
Funder	Catharina Hospital Eindhoven (Netherlands) - Department of Anesthesiology, ICU and Pain Therapy

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

P. Debyelaan 25
Maastricht
6229 HX
Netherlands

Study information

Primary study design	Interventional
Study design	Single centre randomised controlled cross-over study
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	For the cases in which forces are being applied, differs the magnitude of forces between the laryngoscopes?
Completion date	01/01/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

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