NCT03826706

Brief Summary

Along with the technological advances in medicine, videolaryngoscope is the most commonly preferred technique for intubation with double lumen tube. The use of Storz C-MAC D Blade and McGrath MAC X3 Blade videolaryngoscope were compared in intubation of single lung ventilation patients who underwent chest surgery in terms of duration of intubation, hemodynamic response and intubation-induced complications.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

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

January 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

February 15, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2019

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

1 month

First QC Date

January 30, 2019

Last Update Submit

February 1, 2019

Conditions

VideolaryngoscopyDouble Lumen TubeOne-lung Ventilation

Keywords

VideolaryngoscopyDouble lumen tubeOne-lung ventilation

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

    At beginning of Anesthesia induction, 1st, 2nd, 3th and 5th minutes of intubation

  • Adverse Events

    During the first 24 hour postoperatively

Study Arms (2)

C-MAC Videolaryngoscope D blade

ACTIVE COMPARATOR

Patients was intubated with C-MAC videolaryngoscope D blade.

Device: C-MAC Videolaryngoscope D bladeDevice: McGrath MAC Videolaryngoscope X3 blade

McGrath MAC Videolaryngoscope X3 blade

ACTIVE COMPARATOR

Patients was intubated with McGrath MAC Videolaryngoscope X3 blade

Device: C-MAC Videolaryngoscope D bladeDevice: McGrath MAC Videolaryngoscope X3 blade

Interventions

C-MAC Videolaryngoscope D bladeDEVICE

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

C-MAC Videolaryngoscope D bladeMcGrath MAC Videolaryngoscope X3 blade
McGrath MAC Videolaryngoscope X3 bladeDEVICE

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

C-MAC Videolaryngoscope D bladeMcGrath MAC Videolaryngoscope X3 blade

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
  • Patients who was intubated with double lumen tube.

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)

Ahmet Selim Ozkan

Malatya, 44310, Turkey (Türkiye)

Location

Study Officials

  • Ahmet Selim Ozkan

    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. Ahmet Selim Ozkan

Study Record Dates

First Submitted

January 30, 2019

First Posted

February 1, 2019

Study Start

February 15, 2019

Primary Completion

March 30, 2019

Study Completion

April 10, 2019

Last Updated

February 5, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)