- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01827085
Time to Intubation (TTI) of Obese Patients. A Comparison Macintosh Laryngoscope and Stortz Video Laryngoscope (TTI)
Time to Intubation in Obese Patients. A Comparison Between Macintosh Laryngoscope and Stortz Video Laryngoscope
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Obese patients are prone to develop desaturation soon after initiation of anaesthesia compared to patients of normal body weight. It is therefore important to keep the time from when spontaneous breathing to when the airway is secured with a orotracheal tube as short as possible. We will therefore investigate if it is possible to shorten this time by using a Stortz videolaryngoscope.
Patients 18-60 years with ASA grade 1-3 and BMI < 35 that turn up for planned surgery that demands the use of orotracheal tubing and controlled ventilation will be randomly and consecutively enrolled in either of two groups. Patients in both groups will be anaesthetised with the same combination of drugs using Propofol and Remifentanyl or Fentanyl for induction of sleep, combined with Rocuronium for muscle relaxation.
After the induction and relaxation the intubation will be facilitated using either of two laryngoscopes. In the first group a conventional Macintosh laryngoscope, and in the second group a Stortz videolaryngoscope will be used. The time to intubation is defined as the time from grabbing the laryngoscope to when the tube has been inserted and end-tidal carbon dioxide appears on the monitor. Our hypothesis is that we will be able to achieve a faster intubation with the use of videolaryngoscope.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Örebro, Sweden, 70351
- Department of Anaethesia and Intensive Care, University Hospital Örebro
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18-60
- Obesity defined as BMI > 35
- ASA 1-3
Exclusion Criteria:
-known or suspected difficult airway
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Macintosh laryngoscope
Patients will be intubated with a conventional Machintosh laryngoscope
|
|
|
Videolaryngoscope
Intubation with Stortz video laryngoscope
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time to intubation seconds (s)
Time Frame: Up to 1 minute
|
Up to 1 minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Presence and level of postoperational throat pain
Time Frame: 1 hour to 96 hours postoperative
|
If throat pain is present, we will use a visual analogue scale to evaluate the level of throat pain 1h, 24h, 72h and 96h after extubation.
|
1 hour to 96 hours postoperative
|
|
Ease of intubation
Time Frame: Two minutes
|
Two minutes
|
|
|
Incidence of trauma in each group
Time Frame: Two minutes
|
Two minutes
|
|
|
Number of attempts of intubation
Time Frame: Two minutes
|
Two minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EPN2012/015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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