Clinical trial NCT03310866: Macintosh Laryngoscope Assisted Fiberoptic Intubation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Difficult Intubation
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-10-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: intubation time
timeFrame: during intubation
Secondary outcomes:
measure: lower jaw relaxation
timeFrame: during intubation
measure: Vocal cord position
timeFrame: during intubation
measure: Neck movements
timeFrame: during intubation and cuff inflation
measure: Cough
timeFrame: during intubation and cuff inflation
measure: 1st trial success rate
timeFrame: during intubation
measure: the number of trails
timeFrame: during intubation
measure: mean arterial Blood pressure (MBP)
timeFrame: during intubation till 5 minutes after intubation
measure: mean heart rate (HR)
timeFrame: during intubation till 5 minutes after intubation
measure: desaturation (SpO2)
timeFrame: during intubation
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Oncolgy Center, Mansoura University,
state: Dakahlia
Study officials:
References: