NCT05121701

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

November 30, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

March 9, 2022

Status Verified

March 1, 2022

Enrollment Period

3 months

First QC Date

November 15, 2021

Last Update Submit

March 8, 2022

Conditions

COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (1)

  • Intubation time

    Time from Beginning of Intubation to Full Ventilation of the Lungs

    First 5 minutes of the operation

Secondary Outcomes (2)

  • Intubation Comfort

    First 5 minutes of the operation

  • Cormack-Lehane Scoring

    First 5 minutes of the operation

Study Arms (2)

Videolaryngoscopy

ACTIVE COMPARATOR

The patients were intubated with the C-MAC PM-Karl Storz Video laryngoscope.

Device: Videolaryngoscope

Laryngoscopy

ACTIVE COMPARATOR

The patients were intubated with the Macintosh laryngoscope.

Device: Macintosh Laryngoscope

Interventions

VideolaryngoscopeDEVICE

C-MAC PM-Karl Storz

Videolaryngoscopy
Macintosh LaryngoscopeDEVICE

Laryngoscope

Laryngoscopy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-II
  • Elective surgery

You may not qualify if:

  • Intraoral or neck surgery
  • gastroesophageal reflux
  • delayed gastric emptying
  • pregnancy
  • scoliosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzurum City Hospital

Erzurum, 25100, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 21883131BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

November 15, 2021

First Posted

November 16, 2021

Study Start

November 30, 2021

Primary Completion

February 15, 2022

Study Completion

March 1, 2022

Last Updated

March 9, 2022

Record last verified: 2022-03

Locations

TU(1)