Condition category
Surgery
Date applied
26/09/2010
Date assigned
29/10/2010
Last edited
29/10/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Barbe Pieters

ORCID ID

Contact details

P. Debyelaan 25
Maastricht
6229 HX
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

Study hypothesis

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

Catharina Hospital Eindhoven (Netherlands)

Study design

Single centre randomised controlled cross-over study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/11/2010

Overall trial end date

01/01/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant 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

Recruitment start date

01/11/2010

Recruitment end date

01/01/2011

Locations

Countries of recruitment

Netherlands

Trial participating centre

P. Debyelaan 25
Maastricht
6229 HX
Netherlands

Sponsor information

Organisation

Catharina Hospital Eindhoven (Netherlands)

Sponsor details

Department of Anesthesiology
ICU and Pain Therapy
Michelangelolaan 2
Eindhoven
5623 EJ
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Catharina Hospital Eindhoven (Netherlands) - Department of Anesthesiology, ICU and Pain Therapy

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes