C-MAC Video-stylet for Double- Lumen Tracheal Intubation

NCT ID: NCT04757558

Last Updated: 2021-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-20

Study Completion Date

2021-06-01

Brief Summary

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C-MAC Video Stylet secures the airway. It is a completely new type of video endoscope, it combines the advantages of both rigid and flexible intubation endoscopes. Video allows everyone involved in the intubation to visualize the anatomy simultaneously which facilitates communication and teamwork.

Detailed Description

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It can be connected easily to the same C- MAC monitor and Pocket Monitor without requiring any additional light source and camera. Video allows everyone involved in the intubation to visualize the anatomy simultaneously which facilitates communication and teamwork. The device has no lumens so it's very easy to clean. Basically if you can get a tube between the cheek and teeth you can intubate the patient.

Conditions

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Single Lung Ventilation Thoracic Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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C-MAC-VS group

C-MAC-VS will be used to facilitate intubation

Group Type ACTIVE_COMPARATOR

C-MAC video-stylet

Intervention Type DEVICE

Patients will be randomly assigned two group 40 patients each, C-MAC-VS group (VS group) (Karl Storz GmbHand Co.KG, Germany), and control group (C group). This will be done using a closed envelope technique using a computer-generated block randomization method.

control group

direct laryngoscopy using Macintosh laryngoscope will be done for DLT insertion.

Group Type PLACEBO_COMPARATOR

Macintosh laryngoscope

Intervention Type DEVICE

Patients will be randomly assigned two group 40 patients each, C-MAC-VS group (VS group) (Karl Storz GmbHand Co.KG, Germany), and control group (C group). This will be done using a closed envelope technique using a computer-generated block randomization method.

Interventions

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C-MAC video-stylet

Patients will be randomly assigned two group 40 patients each, C-MAC-VS group (VS group) (Karl Storz GmbHand Co.KG, Germany), and control group (C group). This will be done using a closed envelope technique using a computer-generated block randomization method.

Intervention Type DEVICE

Macintosh laryngoscope

Patients will be randomly assigned two group 40 patients each, C-MAC-VS group (VS group) (Karl Storz GmbHand Co.KG, Germany), and control group (C group). This will be done using a closed envelope technique using a computer-generated block randomization method.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* aged 18-60 years,
* of both sex
* of American Society of Anesthesiologists (ASA) physical Status II and III
* undergoing elective intra-thoracic surgeries requiring double lumen intubation. BMI -\< 35 kg/m2,
* with Mallampati score of 1 or 2

Exclusion Criteria

* 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
* r difficult mask ventilation; - severe pulmonary ventilation dysfunction
* risk of pulmonary aspiration.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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rehab zayed

Assisstant Professor of Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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rehab A. Abd Elaziz, Ass.Prof.

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Locations

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rehab Abd Elaziz

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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0304793

Identifier Type: -

Identifier Source: org_study_id

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