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Macintosh Laryngoscope Assisted Fiberoptic Intubation

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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

Tracking Information
First Submitted Date  ICMJE October 5, 2017
First Posted Date  ICMJE October 16, 2017
Last Update Posted Date October 5, 2018
Actual Study Start Date  ICMJE December 15, 2017
Actual Primary Completion Date July 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2017)
  • lower jaw relaxation [ Time Frame: during intubation ]
    (Relaxed= 0, not fully=1, poor= 2)
  • Vocal cord position [ Time Frame: during intubation ]
    (Abducted= 0, Intermediate opening= 1, Closed= 2)
  • Neck movements [ Time Frame: during intubation and cuff inflation ]
    for endotracheal tube or cuff inflation (no=0, slight= 1, vigorous= 2),
  • Cough [ Time Frame: during intubation and cuff inflation ]
    (absent= 0, present=1)
  • 1st trial success rate [ Time Frame: during intubation ]
    in percent
  • the number of trails [ Time Frame: during intubation ]
    (1st trial=1, 2nd trial= 2, 3rd trial= 3)
  • 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
  • mean heart rate (HR) [ Time Frame: during intubation till 5 minutes after intubation ]
    basal, every minute during intubation, 1, 3, 5 minutes after intubation
  • desaturation (SpO2) [ Time Frame: during intubation ]
    oxygen saturation <90% .(Yes=1, No= 0)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Macintosh Laryngoscope Assisted Fiberoptic Intubation
Official Title  ICMJE 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
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 .
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Difficult Intubation
Intervention  ICMJE
  • Device: fiberoptic, airway
    classic fiberoptic bronchoscope, fenstrated airway
  • Device: fiberoptic, Machintosh
    oral fiberoptic brochoscopic, Machintosh laryngoscope
Study Arms  ICMJE
  • Active Comparator: fiberoptic, airway
    Classical fiberoptic intubation assisted by side fenestrated airway and head tilt- chin lift- jaw thrust by 2 anesthetist
    Intervention: Device: fiberoptic, airway
  • Experimental: fiberoptic, Machintosh
    oral Fiberoptic bronchoscopic intubation assisted by Macintosh Laryngoscope, by 2 anesthetist
    Intervention: Device: fiberoptic, Machintosh
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 30, 2018
Actual Primary Completion Date July 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03310866
Other Study ID Numbers  ICMJE R/17.08.102
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: after publication
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: no limit
Access Criteria: e mail mohamed.abdel_latif@yahoo.com
Responsible Party Mansoura University
Study Sponsor  ICMJE Mansoura University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mansoura University
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP