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Completed

NCT Number: NCT03310866

Macintosh Laryngoscope Assisted Fiberoptic Intubation

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 .

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oncolgy Center, Mansoura University,

Al Mansurah, Dakahlia Governorate, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fiberoptic, airway

Device

classic fiberoptic bronchoscope, fenstrated airway

fiberoptic, Machintosh

Device

oral fiberoptic brochoscopic, Machintosh laryngoscope

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 16, 2017
Registry last updated
Oct 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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