NCT04759300

Brief Summary

Videolaryngoscopy provides a better laryngeal view and do not need airway alignment for tracheal intubation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 15, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
11 months until next milestone

Study Start

First participant enrolled

January 10, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

4 months

First QC Date

February 15, 2021

Last Update Submit

May 29, 2022

Conditions

Difficult Mask VentilationDifficult Intubation

Outcome Measures

Primary Outcomes (1)

  • duration of intubation procedure

    assess duration of intubation procedure by using C-MAC VS versus C-MAC D-blade in patients with anticipated difficult airway.

    10 minutes

Study Arms (2)

Group C-MAC VS

ACTIVE COMPARATOR

patients undergoing tracheal intubation using the C-MAC VS.

Device: C-MAC VS

Group C-MAC VL D -blade

PLACEBO COMPARATOR

patients undergoing intubation using the C-MAC VL D-blade.

Device: C-MAC VL D -blade

Interventions

C-MAC VSDEVICE

patients undergoing tracheal intubation using the C-MAC VS

Group C-MAC VS
C-MAC VL D -bladeDEVICE

patients undergoing intubation using the C-MAC VL D-blade.

Group C-MAC VL D -blade

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients with BMI ≥ 30 kg/m2,
  • presence of any predictors of difficult intubation;
  • Mallampati score \> =3;
  • inter-incisor distance \< 3 cm;
  • thyromental distance \< 6 cm;
  • neck extension \< 80°from neck flexion;
  • cervical spine instability; history of difficult endotracheal intubation or difficult mask ventilation

You may not qualify if:

  • patients have increased risk of pulmonary aspiration;
  • have significant medical diseases in term of cardiac, respiratory, hepatic, renal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

rehab Abd Elaziz

Alexandria, 000000, Egypt

Location

Study Officials

  • rehab A. Abd Elaziz, Ass.Prof.

    Alexandria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: The patients will be randomly assigned into two equal groups using computer-generated randomization technique. Group C-MAC VS (VS group) included patients undergoing tracheal intubation using the C-MAC VS. Group C-MAC VL D -blade (D group) included patients undergoing intubation using the C-MAC VL D-blade.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant Professor of Anesthesia

Study Record Dates

First Submitted

February 15, 2021

First Posted

February 18, 2021

Study Start

January 10, 2022

Primary Completion

May 1, 2022

Study Completion

July 1, 2022

Last Updated

June 1, 2022

Record last verified: 2022-05

Locations

EG(1)