NCT03657927

Brief Summary

Along with the technological advances in medicine, videolaryngoscope is the most commonly preferred technique for intubation of expected difficult airway management such as morbidly obese patients. In this prospective controlled clinical study, the purpose is to compare C-MAC videolaryngoscope and McGrath MAC videolaryngoscope in respect to duration of intubation, haemodynamic response, and complications related intubation of morbidly obese patients undergoing bariatric surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

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 7, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

September 8, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2018

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
Last Updated

January 7, 2019

Status Verified

January 1, 2019

Enrollment Period

1 month

First QC Date

August 7, 2018

Last Update Submit

January 4, 2019

Conditions

Difficult IntubationMorbid ObesityVideolaryngoscopy

Keywords

Morbidly ObeseDifficult Airway ManagementVideolaryngoscopy

Outcome Measures

Primary Outcomes (1)

  • Time to intubation

    Time to intubation was defined as the time from when the anesthesiologist picked up the videolaryngoscope to when the anesthesiologist successfully placed the endotracheal tube through the vocal cords

    From beginning of holding videolaryngoscope to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes

Secondary Outcomes (3)

  • Heart Rate

    From beginning of Anesthesia induction to 5th minutes of intubation

  • Mean Arterial Pressure

    From beginning of Anesthesia induction to 5th minutes of intubation

  • Adverse Events

    During the first 24 hour postoperatively

Study Arms (2)

C-MAC Videolaryngoscope

ACTIVE COMPARATOR

Morbidly obese patients intubated with C-MAC Videolaryngoscope

Device: C-MAC videolaryngoscopeDevice: McGrath MAC videolaryngoscope

McGrath MAC Videolaryngoscope

ACTIVE COMPARATOR

Morbidly obese patients intubated with McGrath MAC Videolaryngoscope

Device: C-MAC videolaryngoscopeDevice: McGrath MAC videolaryngoscope

Interventions

C-MAC videolaryngoscopeDEVICE

An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with C-MAC videolaryngoscope.

C-MAC VideolaryngoscopeMcGrath MAC Videolaryngoscope
McGrath MAC videolaryngoscopeDEVICE

An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with McGrath MAC videolaryngoscope.

C-MAC VideolaryngoscopeMcGrath MAC Videolaryngoscope

Eligibility Criteria

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

You may qualify if:

  • American Society of Anesthesiology score III,
  • years,
  • BMI\> 40

You may not qualify if:

  • American Society of Anesthesiology IV,
  • Under 18 years,
  • Over 65 years,
  • Under BMI\<40
  • Obstetric patients,
  • Uncontrolled cerebrovascular disease,
  • Patients who refused written informed consent forms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sedat AKBAS

Malatya, Türkiye-Türkçe, 44090, Turkey (Türkiye)

Location

Related Publications (2)

  • Gaszynski T. Clinical experience with the C-Mac videolaryngoscope in morbidly obese patients. Anaesthesiol Intensive Ther. 2014 Jan-Mar;46(1):14-6. doi: 10.5603/AIT.2014.0003.

    PMID: 24643921BACKGROUND

  • Taylor AM, Peck M, Launcelott S, Hung OR, Law JA, MacQuarrie K, McKeen D, George RB, Ngan J. The McGrath(R) Series 5 videolaryngoscope vs the Macintosh laryngoscope: a randomised, controlled trial in patients with a simulated difficult airway. Anaesthesia. 2013 Feb;68(2):142-7. doi: 10.1111/anae.12075. Epub 2012 Nov 5.

    PMID: 23121470BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sedat Akbas

    Inonu University Medical Faculty

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr. Sedat Akbas

Study Record Dates

First Submitted

August 7, 2018

First Posted

September 5, 2018

Study Start

September 8, 2018

Primary Completion

October 20, 2018

Study Completion

October 30, 2018

Last Updated

January 7, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)