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

NCT ID: NCT03542032

Last Updated: 2019-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Effective I -Gel Mask Airway Placement Technique

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

i-gel placement maneuvers

Intervention Type OTHER

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ankara Diskapi Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

ilkay baran akkuş

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Diskapi Yildirim Beyazit Training Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

I-Gel

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.