NCT04628611

Brief Summary

This is a randomized control study where adult patients had been divided randomly into two equal groups using video laryngoscope in group (V) and flexible intubating laryngoscope in group (F)

Trial Health

100
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2020

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

3.9 years

First QC Date

October 15, 2020

Last Update Submit

November 12, 2020

Conditions

Intubation

Keywords

video laryngoscopyFlexible intubating bronchoscopeAnticipated difficult intubation

Outcome Measures

Primary Outcomes (1)

  • Intubation time

    time from initiation of intubation (application of the laryngoscope into mouth) to ETCO2 detection from the ETT. In cases with failed intubation it was considered from initiationof intubation till failure. Measured by seconds

    Through study completion (Assessment done at the same time of doing intubation) within 60 seconds

Secondary Outcomes (4)

  • Heart rate

    At the same time of doing the intubation within 15 minutes

  • Number of attempts

    AT the same time of doing the intubation within 30 minutes

  • Incidence of complications

    From time of intubation till end of surgery and extubation within 10 hours

  • Blood pressure

    At the same time of intubation within 15 minutes

Study Arms (2)

Video laryngoscopy Group (V) using Storz c-mac laryngoscope

ACTIVE COMPARATOR

video laryngoscope without a channel used for endotracheal intubation, the device used to obtain a view of the larynx, and the endotracheal tube is passed through the vocal cords independent of the device. The device is connected to the monitor via connecting cable

Device: Video laryngoscopy

The flexible intubating laryngoscopy Group (F) using Storz flexible intubation video endoscope set

ACTIVE COMPARATOR

The flexible intubating scope is used to locate the vocal cords and acts as a stylet for the endotracheal tube once the scope is placed into the trachea.This device consists of a flexible insertion cord that contains a small camera at the tip, used to transmit images to camera head. The cord includes a channel for a light source, a working channel for suction or administration of oxygen or local anesthetic, and a cable that allows the operator to flex the tip of the scope. The cord attaches to a handle with a light source,camera head control lever for flexion/extension of the tip, and a working channel port. The device is connected to the monitor via connecting table

Device: Flexible intubating laryngoscopy

Interventions

Video laryngoscopyDEVICE

Endotracheal intubation using video laryngoscopy

Also known as: Storz c-mac laryngoscopy
Video laryngoscopy Group (V) using Storz c-mac laryngoscope
Flexible intubating laryngoscopyDEVICE

Endotracheal intubation using flexible intubating laryngoscope

Also known as: Storz flexible intubation video endoscope set
The flexible intubating laryngoscopy Group (F) using Storz flexible intubation video endoscope set

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • El-Ganzouri score: 2, 3, 4 (Table 1)
  • American Society of Anesthesiology (ASA) I, II, III
  • Elective surgeries

You may not qualify if:

  • Refusal of participation
  • Patients who need a surgical airway (e.g. patients with highly obstructing laryngeal lesions such as cancer tongue, larynx\& maxilla).
  • Patients with laryngeal trauma, especially in those with suspected cricotracheal separation.
  • Patients with craniofacial trauma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Essam AH Mahran, MD

    Assistant Professor of Anesthesia, ICU, and Pain Management, NCI, Cairo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
the participant does not know which group the patient belongs to as every patient was consented for both devices which were ready in the operating theatre
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: two equal groups; group (V) using video laryngoscope(53) and group (F) using flexible intubating laryngoscopy(53).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2020

First Posted

November 13, 2020

Study Start

March 1, 2016

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11