Condition category
Surgery
Date applied
18/07/2011
Date assigned
11/08/2011
Last edited
02/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 3

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jan D'Haese

ORCID ID

Contact details

Laarbeeklaan 101
Jette
1090
Belgium
+32 (0)2 477 89 62
v.vanmossevelde@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2008/210

Study information

Scientific title

Comparative study between a cylindrical cuffed endotracheal tube, a polyurethane tapered shaped cuffed and a PVC tapered shaped cuffed endotracheal tube with respect to intraoperative microaspiration

Acronym

Study hypothesis

We hypothesized that both shape and material have a beneficial influence on microaspiration.

Ethics approval

MEC UZ Brussel approved on 20/11/2008, ref: 2008/210

Study design

Single center randomized interventional 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

Lumbar surgery

Intervention

We aim for 22-24 patients/group, the groups differ from each other by the cuff used: group 1 traditional cylindrical PVC cuff, group 2 tapered shape polyurethane (PU) cuff and group 3 tapered shape PVC cuff.

Microaspiration is assessed with methylthioninium chloride at 10min, 30min, 60min, 120min after intubation if the surgical procedure lasted so long.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Microaspiration as assessed with methylthioninium chloride. We introduced Methylthioninium chloride as dye solution to demonstrate potential aspiration of oropharyngeal secretions along the endotracheal cuff. By means of bronchoscopy we checked the descent of the dye solution.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

15/10/2008

Overall trial end date

31/05/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients sheduled for lumbar surgery
2. Age >17 years and < 75 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

75

Participant exclusion criteria

Comprised narrowed laryngeal or tracheal lumen with the inability of intubation

Recruitment start date

15/10/2008

Recruitment end date

31/05/2011

Locations

Countries of recruitment

Belgium

Trial participating centre

Laarbeeklaan 101
Jette
1090
Belgium

Sponsor information

Organisation

University Hospital Brussels (Belgium)

Sponsor details

Laarbeeklaan 101
Jette
1800
Belgium
+32 (0)2 476 31 34
v.vanmossevelde@gmail.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital Brussels (Belgium)

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