Macintosh Laryngoscope Assisted Fiberoptic Intubation
1 other identifier
interventional
100
1 country
1
Brief Summary
During fiberoptic endotracheal intubation, the perfect airway exposure produced by the classic curved Macintosh laryngoscope in place of head tilt -chin lift-jaw thrust maneuver may increase the accuracy and produce rapid direct vocal cord access in a short time under Inhalation anesthesia to maintain the respiratory drive for grade III\&VI Modified Mallampati .
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 2017
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
First Submitted
Initial submission to the registry
October 5, 2017
CompletedFirst Posted
Study publicly available on registry
October 16, 2017
CompletedStudy Start
First participant enrolled
December 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2018
CompletedOctober 5, 2018
October 1, 2018
7 months
October 5, 2017
October 4, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
intubation time
time from introduction of the tip of the fiber optic laryngoscope till insertion of the tube in the laryngeal inlet down in the trachea in seconds.
during intubation
Secondary Outcomes (9)
lower jaw relaxation
during intubation
Vocal cord position
during intubation
Neck movements
during intubation and cuff inflation
Cough
during intubation and cuff inflation
1st trial success rate
during intubation
- +4 more secondary outcomes
Study Arms (2)
fiberoptic, airway
ACTIVE COMPARATORClassical fiberoptic intubation assisted by side fenestrated airway and head tilt- chin lift- jaw thrust by 2 anesthetist
fiberoptic, Machintosh
EXPERIMENTALoral Fiberoptic bronchoscopic intubation assisted by Macintosh Laryngoscope, by 2 anesthetist
Interventions
oral fiberoptic brochoscopic, Machintosh laryngoscope
Eligibility Criteria
You may qualify if:
- Adult patients with Modified Mallampati (NT-MMT) airway score III,VI
- American Society of Anaesthesiologists (ASA) physical class I-III
- Scheduled for elective cancer surgery under general anesthesia
You may not qualify if:
- Modified Mallampati I,II Airway scored patients.
- History of upper airway surgery.
- Patients with serious deformities of the mandible, maxilla, tongue, pharynx or larynx.
- Patients with a history of significant cardiac and pulmonary diseases,
- Obesity with BMI \>40,
- Epilepsy, pregnancy, mental disease, neurological psychological disorders.
- Communication barrier.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oncolgy Center, Mansoura University,
Al Mansurah, Dakahlia Governorate, 35516, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2017
First Posted
October 16, 2017
Study Start
December 15, 2017
Primary Completion
July 15, 2018
Study Completion
July 30, 2018
Last Updated
October 5, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, CSR
- Time Frame
- no limit
- Access Criteria
- e mail mohamed.abdel\ latif@yahoo.com
after publication