Comparison of I-Gel Laryngeal Mask Airway Placement Methods in Elective Surgery

Comparison of I -Gel Mask Airway Placement Methods in Elective Surgery: Jaw Thrust Maneuver vs Conventional Technique

To compare the jaw thrust maneuver with the conventional technical methods to place the I-Gel laryngeal mask

Study Overview

• Status: Completed
• Conditions: Effective I -Gel Mask Airway Placement Technique
• Intervention / Treatment: Other: i-gel placement maneuvers

Detailed Description

Patients who underwent elective surgery under general anesthesia and who were between the ages of 18 and 75 and who had ASA score I-II-III would be included in the study. Patients' mallampati scores, thyromental distances, mouth openings will be recorded.

Patients will be divided into two groups according to supraglottic airway insertion method.

Both groups will record the insertion time of i-gel, number of trials, operative time, placement complications.

Recorded complications (blood, laryngospasm, etc.) during insertion and removal of supraglottic airway devices will be assessed.

Patients' postoperative sore throat will be questioned and recorded.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Diskapi Yildirim Beyazit Training Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients between the ages of 18 and 75 years
2. American Society of Anesthesiologists I, II or III

Exclusion Criteria:

1. Those with anatomical disorders related to the upper airway
2. lung disease
3. gastric regurgitation
4. Those who have had lung infection in the last 3 weeks
5. Supraglottic airway vehicle not settled
6. Those who are hired for any reason
7. EtCO2> 45

American Society of Anesthesiologists 4 or 5

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: jaw-thrust; the i-gel was inserted with triple airway maneuver (mouth opening, head extension and jaw thrust) This groups will record the insertion time of i-gel, number of trials, operative time, placement complications. Recorded complications (blood, laryngospasm, etc.) during insertion and removal of supraglottic airway devices will be assessed. Patients' postoperative sore throat will be questioned and recorded.	Other: i-gel placement maneuvers; the i-gel was inserted with triple airway maneuver (mouth opening, head extension and jaw thrust) In the classic maneuver , the index finger used as a guide, pushes the back of i-gel towards the hard palate, inserting it into the pharynx till a resistance is felt and the i-gel is then fixed it its place.
No Intervention: classic group; In the classic group, the index finger used as a guide, pushes the back of i-gel towards the hard palate, inserting it into the pharynx till a resistance is felt and the i-gel is then fixed it its place. This groups will record the insertion time of i-gel, number of trials, operative time, placement complications. Recorded complications (blood, laryngospasm, etc.) during insertion and removal of supraglottic airway devices will be assessed. Patients' postoperative sore throat will be questioned and recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
insertion time	Time for successful i-gel insertion	2 minutes
successful insertion number	successful insertion number	2 minutes

Collaborators and Investigators

• Sponsor: Ankara Diskapi Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): March 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: May 18, 2018
• First Submitted That Met QC Criteria: May 30, 2018
• First Posted (Actual): May 31, 2018

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: i-gel; jaw-thrust
• Other Study ID Numbers: I-Gel

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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