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Macintosh Laryngoscope Assisted Fiberoptic Intubation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03310866
Recruitment Status : Completed
First Posted : October 16, 2017
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Mansoura University

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 .

Condition or disease Intervention/treatment Phase
Difficult Intubation Device: fiberoptic, airway Device: fiberoptic, Machintosh Not Applicable

Detailed Description:

Managing difficult airway is critical for anesthesia-related morbidity and mortality. Fiberoptic laryngoscope is a reliable tool for endotracheal intubation in difficult airway cases (Modified Mallampatti III&IV), but always there is difficulty to visualize the glottis due to airway tendency to collapse, classically a specific fiberoptic airway with a side way is used and it may added head tilt chin lift jaw thrust. A new technique utilizing sevoflurane anesthesia to maintain the respiratory drive without exposing the patient to the stress of the awake airway instrumentation. Simultaneous utilization of both Macintosh curved laryngoscope and Fiberoptic bronchoscope during Endotracheal intubation (ETT) will be examined for the efficacy during difficult airway management.

All patients should be examined preoperatively for the scoring Modified Mallampati or non tongue protrusion mallampati (NT-MMT) airway score. The pharyngeal structures were then evaluated and the best view (lowest class) was recorded. The classification follows m-MMT and is as follows: class 1, full visibility of tonsils, uvula, and soft palate; class 2, visibility of hard and soft palate, upper portion of tonsils and uvula; class 3, visibility of the soft and hard palate and base of the uvula; and class 4, visibility of only the hard palate, class III or IV patients were included in the study. Inhalational anesthesia use maintains the respiratory drive of the patient allowing less stressful technique.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Macintosh Laryngoscope Assisted Flexible Fiber Optic Endotracheal Intubation Versus Classic Fiber Optic Laryngoscope Alone Endotracheal Intubation for Modified Mallampati III&IV Patients : A Prospective Randomized Controlled Study
Actual Study Start Date : December 15, 2017
Actual Primary Completion Date : July 15, 2018
Actual Study Completion Date : July 30, 2018

Arm Intervention/treatment
Active Comparator: fiberoptic, airway
Classical fiberoptic intubation assisted by side fenestrated airway and head tilt- chin lift- jaw thrust by 2 anesthetist
Device: fiberoptic, airway
classic fiberoptic bronchoscope, fenstrated airway

Experimental: fiberoptic, Machintosh
oral Fiberoptic bronchoscopic intubation assisted by Macintosh Laryngoscope, by 2 anesthetist
Device: fiberoptic, Machintosh
oral fiberoptic brochoscopic, Machintosh laryngoscope




Primary Outcome Measures :
  1. intubation time [ Time Frame: during intubation ]
    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.


Secondary Outcome Measures :
  1. lower jaw relaxation [ Time Frame: during intubation ]
    (Relaxed= 0, not fully=1, poor= 2)

  2. Vocal cord position [ Time Frame: during intubation ]
    (Abducted= 0, Intermediate opening= 1, Closed= 2)

  3. Neck movements [ Time Frame: during intubation and cuff inflation ]
    for endotracheal tube or cuff inflation (no=0, slight= 1, vigorous= 2),

  4. Cough [ Time Frame: during intubation and cuff inflation ]
    (absent= 0, present=1)

  5. 1st trial success rate [ Time Frame: during intubation ]
    in percent

  6. the number of trails [ Time Frame: during intubation ]
    (1st trial=1, 2nd trial= 2, 3rd trial= 3)

  7. mean arterial Blood pressure (MBP) [ Time Frame: during intubation till 5 minutes after intubation ]
    basal, every minute during intubation, 1, 3, 5 minutes after intubation

  8. mean heart rate (HR) [ Time Frame: during intubation till 5 minutes after intubation ]
    basal, every minute during intubation, 1, 3, 5 minutes after intubation

  9. desaturation (SpO2) [ Time Frame: during intubation ]
    oxygen saturation <90% .(Yes=1, No= 0)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03310866


Locations
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Egypt
Oncolgy Center, Mansoura University,
Mansoura, Dakahlia, Egypt, 35516
Sponsors and Collaborators
Mansoura University
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Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT03310866    
Other Study ID Numbers: R/17.08.102
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: after publication
Supporting Materials: Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: no limit
Access Criteria: e mail mohamed.abdel_latif@yahoo.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No