Covid-19 Pandemic and Use of Video Laryngoscopy
Primary Purpose
COVID-19 Pneumonia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Videolaryngoscope
Macintosh Laryngoscope
Sponsored by
About this trial
This is an interventional other trial for COVID-19 Pneumonia
Eligibility Criteria
Inclusion Criteria:
- ASA I-II
- Elective surgery
Exclusion Criteria:
- Intraoral or neck surgery
- gastroesophageal reflux
- delayed gastric emptying
- pregnancy
- scoliosis
Sites / Locations
- Erzurum City Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Videolaryngoscopy
Laryngoscopy
Arm Description
The patients were intubated with the C-MAC PM-Karl Storz Video laryngoscope.
The patients were intubated with the Macintosh laryngoscope.
Outcomes
Primary Outcome Measures
Intubation time
Time from Beginning of Intubation to Full Ventilation of the Lungs
Secondary Outcome Measures
Intubation Comfort
Scale(0=bad, 1=moderate, 2=good 3=very good)
Cormack-Lehane Scoring
Scale(1= Full view of glottis, 2=Partial view of glottis 3=Only epiglottis seen, none of glottis seen 4=Neither glottis nor epiglottis seen)
Full Information
NCT ID
NCT05121701
First Posted
November 15, 2021
Last Updated
March 8, 2022
Sponsor
Van Bölge Eğitim ve Araştırma Hastanesi
1. Study Identification
Unique Protocol Identification Number
NCT05121701
Brief Title
Covid-19 Pandemic and Use of Video Laryngoscopy
Official Title
Airway Management During the Covid-19 Pandemic: A Comparison of Direct Laryngoscopy Versus Video Laryngoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 30, 2021 (Actual)
Primary Completion Date
February 15, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Van Bölge Eğitim ve Araştırma Hastanesi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes a highly contagious infection with the highest viral load in the upper respiratory secretions. Despite using personal protective equipment, SARS-CoV-2 contamination to the healthcare personnel is possible during the airway management of infected patients. Direct laryngoscopy remains as the most common method for endotracheal intubation. Our study aimed to compare the use of video laryngoscopy with direct laryngoscopy for tracheal intubation in adult patients receiving general anesthesia for elective surgery during the COVID-19 pandemic.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Videolaryngoscopy
Arm Type
Active Comparator
Arm Description
The patients were intubated with the C-MAC PM-Karl Storz Video laryngoscope.
Arm Title
Laryngoscopy
Arm Type
Active Comparator
Arm Description
The patients were intubated with the Macintosh laryngoscope.
Intervention Type
Device
Intervention Name(s)
Videolaryngoscope
Intervention Description
C-MAC PM-Karl Storz
Intervention Type
Device
Intervention Name(s)
Macintosh Laryngoscope
Intervention Description
Laryngoscope
Primary Outcome Measure Information:
Title
Intubation time
Description
Time from Beginning of Intubation to Full Ventilation of the Lungs
Time Frame
First 5 minutes of the operation
Secondary Outcome Measure Information:
Title
Intubation Comfort
Description
Scale(0=bad, 1=moderate, 2=good 3=very good)
Time Frame
First 5 minutes of the operation
Title
Cormack-Lehane Scoring
Description
Scale(1= Full view of glottis, 2=Partial view of glottis 3=Only epiglottis seen, none of glottis seen 4=Neither glottis nor epiglottis seen)
Time Frame
First 5 minutes of the operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA I-II
Elective surgery
Exclusion Criteria:
Intraoral or neck surgery
gastroesophageal reflux
delayed gastric emptying
pregnancy
scoliosis
Facility Information:
Facility Name
Erzurum City Hospital
City
Erzurum
ZIP/Postal Code
25100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21883131
Citation
Piepho T, Fortmueller K, Heid FM, Schmidtmann I, Werner C, Noppens RR. Performance of the C-MAC video laryngoscope in patients after a limited glottic view using Macintosh laryngoscopy. Anaesthesia. 2011 Dec;66(12):1101-5. doi: 10.1111/j.1365-2044.2011.06872.x. Epub 2011 Aug 25.
Results Reference
background
Learn more about this trial
Covid-19 Pandemic and Use of Video Laryngoscopy
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