NCT05158088

Brief Summary

Video Laryngoscope Versus a USB Borescope Aided Endotracheal Intubation in Adults With Anticipated Difficult Airway

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 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

August 22, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 15, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

December 20, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2022

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

April 15, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

August 22, 2021

Last Update Submit

April 13, 2022

Conditions

Intubation; Difficult or Failed

Keywords

AirwayIntubationVideolaryngoscopeBorescope

Outcome Measures

Primary Outcomes (1)

  • Time of intubation

    in seconds

    5 minutes

Secondary Outcomes (5)

  • Blood pressure before intubation, every 5 minutes after intubation till 15 minutes after intubation

    15 minutes

  • Heart rate Heart rate

    15 minutes

  • The degree of view clarity

    1 minute

  • Incidence of complications

    48 hours

  • Number of trials for correct endotracheal intubation

    2 minutes

Study Arms (2)

Borescope group

ACTIVE COMPARATOR

Using an Endotracheal tube mounted over Borescope with the aid of conventional laryngoscope for intubation

Device: Borescope

Videolaryngoscope group

ACTIVE COMPARATOR

Using videolaryngoscope for intubation

Device: Video laryngoscope

Interventions

BorescopeDEVICE

Endotracheal intubation using borescope

Borescope group
Video laryngoscopeDEVICE

Endotracheal intubation using video laryngoscope

Videolaryngoscope group

Eligibility Criteria

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

You may qualify if:

  • American Society of Anesthesiologist ASA physical status I-II patients. 2.Both genders. 3.Age18-60 years old 4.BMI \<35 5.patients with El-Ganzouri score more than or equal to 4

You may not qualify if:

  • Presence of pulmonary diseases
  • Uncontrolled hypertension
  • Ischemic heart disease
  • Cervical spine fracture
  • Limited mouth opening
  • known to have tumors or polyps in the upper airway
  • History of difficult intubation or difficult bag-mask ventilation
  • Patients with difficult bag-mask ventilation after induction of anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Cairo, 11562, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia and surgical ICU

Study Record Dates

First Submitted

August 22, 2021

First Posted

December 15, 2021

Study Start

December 20, 2021

Primary Completion

March 28, 2022

Study Completion

April 1, 2022

Last Updated

April 15, 2022

Record last verified: 2022-04

Locations

EG(1)