NCT01104090

Brief Summary

The purpose of this study is to determine the safety and efficacy of the C-MAC (Karl Storz Endoscopy, Inc., Tuttlingen, Germany) video intubation system guided intubation techniques. We hypothesize that the C-MAC video laryngoscope is safe and efficacious in terms of successful endotracheal intubation. The C-MAC may be a safe and suitable alternative device for routine and difficult laryngoscopy and tracheal intubation. This is the first study to investigate the performance of C-MAC in clinical practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2010

Typical duration 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

Study Start

First participant enrolled

February 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
9.8 years until next milestone

Results Posted

Study results publicly available

November 1, 2021

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

7 months

First QC Date

April 13, 2010

Results QC Date

October 1, 2021

Last Update Submit

October 1, 2021

Conditions

Intubation; Difficult

Keywords

C-MACdirect laryngoscopyindirect laryngoscopyto determine the safety and efficacy of the C-MAC

Outcome Measures

Primary Outcomes (1)

  • Time for Intubation

    Time taken for successful placement of endotracheal tube (that is, intubation).

    at the time of intubation (about 10 seconds)

Secondary Outcomes (6)

  • Laryngoscopy Time

    at the time of laryngoscopy (about 10 seconds)

  • Airway View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (Before External Manipulation)

    at the time of laryngoscopy (about 10 seconds)

  • Airway View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (After External Manipulation)

    at the time of laryngoscopy (about 10 seconds)

  • Number of Participants With Successful Intubation

    at the time of intubation (about 10 seconds)

  • Ease of Intubation as Assessed by a Rating Scale

    at the time of intubation (about 10 seconds)

  • +1 more secondary outcomes

Study Arms (2)

C-MAC direct laryngoscopy, then C-MAC indirect laryngoscopy

EXPERIMENTAL

Patients assigned to this arm will be intubated using C-MAC with direct laryngoscopy first and then using C-MAC with indirect laryngoscopy.

Device: C-MAC direct laryngoscopyDevice: C-MAC Indirect laryngoscopy

C-MAC indirect laryngoscopy, then C-MAC direct laryngoscopy

EXPERIMENTAL

Patients assigned to this arm will be intubated using C-MAC with indirect laryngoscopy first and then using C\_MAC with direct laryngoscopy.

Device: C-MAC direct laryngoscopyDevice: C-MAC Indirect laryngoscopy

Interventions

C-MAC direct laryngoscopyDEVICE

Patients will be intubated using C-MAC with direct laryngoscopy.

C-MAC direct laryngoscopy, then C-MAC indirect laryngoscopyC-MAC indirect laryngoscopy, then C-MAC direct laryngoscopy
C-MAC Indirect laryngoscopyDEVICE

Patients will be intubated using C-MAC with indirect laryngoscopy.

C-MAC direct laryngoscopy, then C-MAC indirect laryngoscopyC-MAC indirect laryngoscopy, then C-MAC direct laryngoscopy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 - 80 years of age
  • ASA I - III
  • Mallampati I-III
  • Mouthopening \> 4cm

You may not qualify if:

  • Age \< 18 years and \> 80 years of age
  • ASA IV - V
  • Mallampati IV - V
  • Mouthopening \< 4cm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Results Point of Contact

Title
Davide Cattano, MD, PhD
Organization
The University of Texas Health Science Center at Houston
Davide.Cattano@uth.tmc.edu
(713) 500-6200

Study Officials

  • Davide Cattano, MD, PhD

    University of Texas Medical School at Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor - Anesthesiology

Study Record Dates

First Submitted

April 13, 2010

First Posted

April 15, 2010

Study Start

February 1, 2010

Primary Completion

September 1, 2010

Study Completion

February 1, 2012

Last Updated

November 1, 2021

Results First Posted

November 1, 2021

Record last verified: 2021-10

Locations

US(1)