- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03184246
The Depth of Endotracheal Tube Insertion
December 5, 2018 updated by: Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove
The Depth of Endotracheal Tube Insertion - Use of Direct Laryngoscopy and Videolaryngoscopy (GlideScope), Comparison of Methods
The investigators suppose that direct laryngoscopy is connected with deeper insertion of endotracheal tube in comparison to videolaryngoscopy.
Correction of this malposition can cause postoperative discomfort and further complications in some patients.Routine use of videolaryngoscopy could minimize these problems.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
100 patients scheduled for elective neurosurgical procedures will be randomized into two groups.
Patients in group A will be intubated by videolaryngoscopy (GlideScope), patients in group B by direct laryngoscopy, in both groups will be rigid stylet used.
Intubation will be done under propofol anesthesia, targeted entropy 40 to 50, and deep relaxation (neuromuscular transmission target level 0).
Sufentanil will be used to block tracheal reflexes.
In both groups the depth of insertion of tracheal tube will be measured in the mouth corner immediately after intubation.
Next day, the unpleasant sensations and complications will be recorded (sore throat, stridor, hoarseness, cough and nausea and vomiting) during control visit of patients.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hradec Kralove, Czechia, 50005
- University Hospital Hradec Kralove
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- American Society of Anesthesiologists physical status I - III
Exclusion Criteria:
- postoperative ventilation, laryngeal tumors, conditions after tracheotomy or laryngeal operations, cervical spinal hernia extraction
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GlideScope
intubation with GlideScope
|
videolaryngoscopy (GlideScope) will be used for intubation
|
Active Comparator: Direct laryngoscopy
intubation with laryngoscope
|
direct laryngoscopy will be used for intubation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the depth of primary insertion of tracheal tube
Time Frame: in a minute after intubation
|
cm
|
in a minute after intubation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
sums of manipulation with tracheal tube
Time Frame: 2 minutes after intubation
|
number
|
2 minutes after intubation
|
complications after intubation
Time Frame: 24 hours after surgery
|
number
|
24 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 30, 2017
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
December 4, 2018
Study Registration Dates
First Submitted
June 8, 2017
First Submitted That Met QC Criteria
June 9, 2017
First Posted (Actual)
June 12, 2017
Study Record Updates
Last Update Posted (Actual)
December 6, 2018
Last Update Submitted That Met QC Criteria
December 5, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- University Hospital
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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