The Efficiency of Different Oropharyngeal Airways as a Conduit for Fiberoptic Intubation. Comparative Study

60 Patients were randomly allocated into three equal groups, after induction of general anesthesia one of the three airways included in the study (Modified Williams, Modified Gudle's and LMA MADgic airway) was used as a conduit for endotracheal tube placement using fiberoptic bronchoscopy. Airway insertion time, ease of insertion, adaptation to oral cavity and intubation time was recorded.

Study Overview

• Status: Completed
• Conditions: Fiberoptic Tracheal Intubation
• Intervention / Treatment: Device: Modified Williams airway; Device: Modified Guedle's airway; Device: LMA MADgic airway

Detailed Description

The study was conducted in Kasr Alainy hospital, faculty of medicine, Cairo University.

After approval of ethical committee and informed written consent from each patient, 60 patient aging above 18 years, ASA I-II , with Ganzouri airway score <4 and undergoing elective surgeries under general anesthesia were included in the study.

Patients were randomly allocated into three equal groups:

Group M (GM) (n=20 patients): patient was intubated using LMA MADgic airway. Group W (GW) (n=20 patients): patient was intubated using modified Williams airway.

Group G (GG) (n=20 patients): patient was intubated using modified Guedel's airway.

Randomization was performed by random computer allocation with numbered closed opaque envelopes.

The study was performed by expert anesthesiologist in FOB intubation. In the preparation room, all patients was cannulated with a 20 gauge venous cannula and 0.02mg/kg Midazolam was given. Patient transferred to the operating room and was monitored with non-invasive blood pressure, pulse oximetry and ECG. After preoxygenation using a facemask for 5 min, induction of anesthesia was done with 2mg/kg propofol, 1 μg/kg of fentanyl and 0.6 mg/kg of atracurium.

After loss of consciousness the selected airway according to group randomization was inserted into the mouth (size selection and technique of insertion according to manufacturer instruction). Time of insertion defined as the time, in seconds, from touching the patients' mouth with the airway until capnographic confirmation of ventilation by facemask. The ease of insertion was determined by number of attempts of airway insertion. Adaptation of the airway was determined by adequacy of ventilation, fitness to the oral cavity and appearance of successive ETco2 waves.

Manual positive-pressure ventilation was then started with 100% oxygen and 1-1.5% isoflurane through the facemask for 3 min until complete muscle relaxation was confirmed (when train-of-four count becomes zero).

Loaded FOB was inserted for intubation through the airway, laryngeal view grade was recorded (LVG) using Brimacomb and Berry scale; thereafter, the fiberscope was advanced into the trachea to a level just above the carina and the tracheal tube was railroaded over it.

Tracheal intubation could be facilitated by tube rotation, jaw thrust, neck extension or flexion and adjustment of the airway was allawed and was recorded. The intubation time was recorded ; that is, the time from cessation of manual ventilation using a facemask until restarting of ventilation through the tracheal tube.

The airway was removed except the LMA MADgic airway which was removed before ETT insertion. The ease of airway removal was evaluated by the anesthesiologist.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA physical state I-II Ganzouri airway score less than 4

Exclusion Criteria:

• ASA physical state III-IV. Patients with Ganzouri airway score more than 4. Patients with risk of aspiration of gastric content. Any anatomical abnormalities or iatrogenic injuries that invalidate Ganzouri airway score.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group W; This group was intubated by Fiberoptic bronchoscope assisted by Modified Williams airway as a conduit	Device: Modified Williams airway; This airway used as a conduit for fiberoptic bronchoscopic tracheal intubation in Group W; Other Names: Fikrey airway
Experimental: Group G; This group was intubated by Fiberoptic bronchoscope assisted by Modified Guedle's airway as a conduit	Device: Modified Guedle's airway; This airway used as a conduit for fiberoptic bronchoscopic tracheal intubation in Group G
Experimental: Group M; This group was intubated by Fiberoptic bronchoscope assisted by LMA MADgic airway as a conduit	Device: LMA MADgic airway; This airway used as a conduit for fiberoptic bronchoscopic tracheal intubation in Group M

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of intubation	The time from cessation of manual ventilation using a facemask until restarting of ventilation through the tracheal tube	within 15 minutes from induction of general anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of insertion	Time from touching the patients' mouth with the airway until capnographic confirmation of ventilation by facemask	within 15 minutes from induction of general anesthesia
Laryngeal View Grade	Degree of vocal cord visualization by fiberoptic bronchoscope	within 15 minutes from induction of general anesthesia

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital
• Investigators: Principal Investigator: Sara Ahmed Abdallah, Master, Kasr El Aini Hospital

Publications and helpful links

General Publications

• Dina N. Abbas, Ekramey M. Abdghaffar. Comparison of the air-Q intubating laryngeal airway versus the modified Williams intubating airway as aids for training in fiberoptic tracheal intubation. Ain-Shams Journal of Anesthesiology 2013, 6:134-139.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: May 27, 2017
• First Submitted That Met QC Criteria: May 31, 2017
• First Posted (Actual): June 2, 2017

Study Record Updates

• Last Update Posted (Actual): June 2, 2017
• Last Update Submitted That Met QC Criteria: May 31, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: N-40-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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