NCT05091281

Brief Summary

The double lumen endotracheal tube (DLT) is the most widely-used device for single lung ventilation in current thoracic anesthesia practice. In recent years, the routine application of the videolaryngoscope for single lumen endotracheal intubation has increased; nevertheless there are few studies of the use of the videolaryngoscope for DLT. The authors wondered whether there were benefits to using the videolaryngoscope for DLT placement in patients with predicted normal airways. Therefore, this study was designed to compare the performances of the GlideScope®, the C-MAC®(D) videolaryngoscope and the Macintosh laryngoscope in DLT intubation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 25, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

November 5, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2022

Completed
Last Updated

January 12, 2022

Status Verified

January 1, 2022

Enrollment Period

2 months

First QC Date

October 1, 2021

Last Update Submit

January 11, 2022

Conditions

Keywords

MacintoshlaryngoscopeGlideScopeC-MACvideolaryngoscopedouble lumen tube

Outcome Measures

Primary Outcomes (2)

  • Double lumen tube insertion times in seconds

    Double lumen tube insertion times by the three types of laryngoscopes were recorded

    2 minutes

  • first-pass success rates

    Double lumen tube insertion first-pass success ratesby the three types of laryngoscopes were recorded

    2 minutes

Secondary Outcomes (2)

  • Blood pressure measurement in mm Hg

    150 minutes

  • Heart rate measurement in beat/minute

    150 minutes

Study Arms (3)

Group I

ACTIVE COMPARATOR

After induction of anesthesia intubation was done by Macintosh laryngoscope

Device: Intubation of the double lumen tube by Macintoch laryngoscope

Group II

ACTIVE COMPARATOR

After induction of anesthesia intubation was done by GlideScope®videolaryngoscope

Device: Intubation of the double lumen tube by Glidescope videolaryngoscope

Group III

ACTIVE COMPARATOR

After induction of anesthesia intubation was done byC-MAC®(D) videolaryngoscope

Device: Intubation of the double lumen tube by C-MAC®(D) videolaryngoscope

Interventions

After induction of anesthesia insertion of the double lumen tube was done by Macintosh laryngoscope

Group I

After induction of anesthesia insertion of the double lumen tube was done by GlideScope® videolaryngoscope

Group II

After induction of anesthesia insertion of the double lumen tube was done by C-MAC®(D) videolaryngoscope

Group III

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-II
  • BMI \< 35 kg/m2
  • Mallampati score of 1 or 2

You may not qualify if:

  • Patients with risk of gastric aspiration
  • Patients with risk of gastric aspiration
  • Presence of any predictors of difficult intubation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mona Mohamed Mogahed

Tanta, Elgharbia, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Before the study, the computerized randomization will be performed and the allocation results will be placed in individual numbered and sealed envelopes. Patients remained blinded about their intubation technique until post-operative assessment was completed.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Patients randomly assigned into Macintosh group, GlideScope (Verathon Medical, Bothwell, UT, USA) group, or CMAC(D) (Karl Storz GmbHand Co.KG, Tuttlingen, Germany) group. After pre-oxygenation , anesthesia will be induced with intravenous midazolam 0.05 mg. kg- 1 , propofol 1.5 mg. kg- 1 , fentanyl 5 μg. kg- 1 , and rocuronium 0.6 mg. kg- 1 . . The DLT will be inserted with the distal concavity facing anteriorly until the bronchial lumen cuff passed the vocal cords. The stylet will be then removed, and rotation will be performed while tube will be advanced. The left DLT rotated 90° counter-clockwise, and the right DLT will be rotated 90° clockwise to enter the respective mainstem bronchus.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 1, 2021

First Posted

October 25, 2021

Study Start

November 5, 2021

Primary Completion

January 10, 2022

Study Completion

January 10, 2022

Last Updated

January 12, 2022

Record last verified: 2022-01

Locations