Macintosh Laryngoscope Assisted Fiberoptic Intubation

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

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 .

Study Overview

• Status: Completed
• Conditions: Difficult Intubation
• Intervention / Treatment: Device: fiberoptic, airway; Device: fiberoptic, Machintosh

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: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35516
      • Oncolgy Center, Mansoura University,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2017
• Primary Completion (Actual): July 15, 2018
• Study Completion (Actual): July 30, 2018

Study Registration Dates

• First Submitted: October 5, 2017
• First Submitted That Met QC Criteria: October 10, 2017
• First Posted (Actual): October 16, 2017

Study Record Updates

• Last Update Posted (Actual): October 5, 2018
• Last Update Submitted That Met QC Criteria: October 4, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: R/17.08.102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: after publication
• IPD Sharing Time Frame: no limit
• IPD Sharing Access Criteria: e mail mohamed.abdel_latif@yahoo.com
• IPD Sharing Supporting Information Type: Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No