Macintosh Laryngoscope Assisted Fiberoptic Intubation

Difficult Intubation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03310866
• Other study ID #: R/17.08.102
• Status: Completed
• Phase: N/A
• Start date: December 15, 2017
• Est. completion date: July 30, 2018

Study information

• Verified date: October 2018
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 30, 2018
• Est. primary completion date: July 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Difficult Intubation

Intervention

Device:
• fiberoptic, airway
classic fiberoptic bronchoscope, fenstrated airway
• fiberoptic, Machintosh
oral fiberoptic brochoscopic, Machintosh laryngoscope

Locations

Country	Name	City	State
Egypt	Oncolgy Center, Mansoura University,	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	lower jaw relaxation	(Relaxed= 0, not fully=1, poor= 2)	during intubation
Secondary	Vocal cord position	(Abducted= 0, Intermediate opening= 1, Closed= 2)	during intubation
Secondary	Neck movements	for endotracheal tube or cuff inflation (no=0, slight= 1, vigorous= 2),	during intubation and cuff inflation
Secondary	Cough	(absent= 0, present=1)	during intubation and cuff inflation
Secondary	1st trial success rate	in percent	during intubation
Secondary	the number of trails	(1st trial=1, 2nd trial= 2, 3rd trial= 3)	during intubation
Secondary	mean arterial Blood pressure (MBP)	basal, every minute during intubation, 1, 3, 5 minutes after intubation	during intubation till 5 minutes after intubation
Secondary	mean heart rate (HR)	basal, every minute during intubation, 1, 3, 5 minutes after intubation	during intubation till 5 minutes after intubation
Secondary	desaturation (SpO2)	oxygen saturation <90% .(Yes=1, No= 0)	during intubation