Plain English Summary
Background and study aims
Postoperative pulmonary infections (lung infections) lead to significant morbidity (illness) and mortality (death), burdening healthcare cost, even though risk can be more accurately determined. A major cause of pulmonary infections is atelectasis which is the collapse of the lung due to a lack of gas. Intubation is when a plastic tube is placed into the windpipe to help keep the airway open using an endotracheal tube (ETT). Although a lot of effort has gone into correcting it, microaspiration (fluid in the lungs) of contaminated upper airway secretions due to an inadequately sealed ETT is still a major cause of post-intubation pneumonia. The design of the ETT has been improved, using different materials and shapes in order to provide a better seal. The aim of this study is to see how much microaspiration occurs using a dye solution in intubated patients in a short term time frame during lumbar surgery when comparing different types of ETT.
Who can participate?
Adults between the ages of 18 to 74 who are undergoing lumbar surgery.
What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group receive the traditional round cuff made of PVC. Those in the second group receive a tapered shaped polyurethane (PU) cuff and the last group receives a tapered shape PVC cuff. Participants are assessed for their levels of microaspiration (through the dye) at ten minutes, 30 minutes, 60 minute and 120 minutes after the surgery.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
University Hospital Brussels (Belgium)
When is the study starting and how long is it expected to run for?
October 2008 to May 2011
Who is funding the study?
University Hospital Brussels (Belgium)
Who is the main contact?
Dr Jan Poelaert
jan.poelaert@uzbrussel.be
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