C-MAC Video-stylet for Double- Lumen Tracheal Intubation
1 other identifier
interventional
80
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2020
Shorter than P25 for not_applicable
1 active site
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
Study Start
First participant enrolled
December 20, 2020
CompletedFirst Submitted
Initial submission to the registry
February 13, 2021
CompletedFirst Posted
Study publicly available on registry
February 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedFebruary 17, 2021
February 1, 2021
5 months
February 13, 2021
February 13, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
the time taken for intubation (TTI) by C-MAC-VS
timing for intubation
5 minutes
Study Arms (2)
C-MAC-VS group
ACTIVE COMPARATORC-MAC-VS will be used to facilitate intubation
control group
PLACEBO COMPARATORdirect laryngoscopy using Macintosh laryngoscope will be done for DLT insertion.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
rehab Abd Elaziz
Alexandria, 000000, Egypt
Study Officials
- PRINCIPAL INVESTIGATOR
rehab A. Abd Elaziz, Ass.Prof.
Alexandria University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assisstant Professor of Anesthesia
Study Record Dates
First Submitted
February 13, 2021
First Posted
February 17, 2021
Study Start
December 20, 2020
Primary Completion
May 20, 2021
Study Completion
June 1, 2021
Last Updated
February 17, 2021
Record last verified: 2021-02