Effect of Head-neck Rotation on I-gel™ Insertion

October 1, 2024 updated by: Karam Nam, MD, Seoul National University Hospital

Effect of Head-neck Rotation on the Success Rate At First Attempt of I-gel™ Insertion

According to previous studies, head and neck rotation reduces the tongue from being rolled back by gravity, which resulted in increasing patency of the upper airway. Therefore, the purpose of this study is to verify whether head and neck rotation increases the first attempt success rate of i-gel™.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

I-gel™ insertion has been reported that the success rate of insertion on the first attempt is 78.5%. There may be several causes of insertion failure. Tongue folding is a major obstacle preventing appropriate i-gel™ placement. To solve this problem, the previous study has proven the efficacy of the rotational technical for I-gel™ insertion and reported a success rate of 97%.

However, the rotation of i-gel™ in the oral cavity may be limited, and it may take some learning curve to get used to it. According to previous studies, head and neck rotation increases the cross-sectional area of the upper airway, which resulted in increasing patency of the upper airway. Therefore, the purpose of this study is to verify whether head and neck rotation increases the first attempt success rate of i-gel™.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
172

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ASA Physical Status Classification Grade 1-3
  • Patients who can provide written consent to participate in clinical trials
  • Patients requiring the I-gel™ during surgery

Exclusion Criteria:

  • Outpatient surgery
  • Patients who have the neurologic disease or cognitive impairment
  • Patients who take antipsychotic drugs
  • Body mass index > 35 kg/m2
  • Mouth opening < 2.5 cm
  • Limited neck extension or cervical mobilization (Ex: Atlanto-axial subluxation, History of cervical spine surgery or head and neck surgery)
  • Those with a recent sore throat
  • Those with weak dentation
  • Patients at risk of aspiration (Ex: Pregnancy, Gastroesophageal reflux disease or hiatus hernia)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard method
Insert I-gel™ according to the manufacturer's instruction. Take the sniffing position and gently move the i-gel™ along the hard palate to the soft palate and the posterior oropharynx.
Procedure: Standard method
Insert I-gel™ according to the manufacturer's instruction. Take the sniffing position and gently move the i-gel™ along the hard palate to the soft palate and the posterior oropharynx.
Experimental: Head-neck rotation
After rotating the patient's head and neck to the left maximally, insert the i-gel™ from the right side of the tongue to the midline. When the tip reaches the soft palate and oropharynx positions, turn the head and neck back to the neutral position.
Procedure: Hean and Neck Rotation
After rotating the patient's head and neck to the left maximally, insert the i-gel™ from the right side of the tongue to the midline. When the tip reaches the soft palate and oropharynx positions, turn the head and neck back to the neutral position.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
First attempt success rate
Time Frame: Induction of anesthesia during intraoperative period
After the first attempt on insertion of i-gel™ without withdrawal or redirection, the effectiveness of the airway is judged based on a square-wave capnograph and no audible leak with peak airway pressures ≥ 10 cmH2O during manual ventilation.
Induction of anesthesia during intraoperative period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Second attempt success rate
Time Frame: Induction of anesthesia during intraoperative period
After the second attempt on insertion of i-gel™, the effectiveness of the airway is judged based on a square-wave capnograph and no audible leak with peak airway pressures ≥ 10 cmH2O during manual ventilation.
Induction of anesthesia during intraoperative period
Insertion time for successful insertion; s
Time Frame: Induction of anesthesia during intraoperative period
Time from insertion of i-gel™ into the oral cavity until appropriate placement.
Induction of anesthesia during intraoperative period
Time required for successful insertion; s
Time Frame: Induction of anesthesia during intraoperative period
Time insertion of i-gel™ into the oral cavity until After the first attempt on insertion of i-gel™ without withdrawal or redirection, the effectiveness of the airway is judged based on a square-wave capnograph and no audible leak with peak airway pressures ≥ 10 cmH2O during manual ventilation.
Induction of anesthesia during intraoperative period
Third attempt
Time Frame: Induction of anesthesia during intraoperative period
If the attempt of assigned method fails twice, then try third attempt.
Induction of anesthesia during intraoperative period
Third attempt success rate
Time Frame: Induction of anesthesia during intraoperative period
If the attempt of assigned method fails, but the third attempt is successful with another method.
Induction of anesthesia during intraoperative period
Manipulations required rate
Time Frame: Induction of anesthesia during intraoperative period
An assistant assists when all attempt fail.
Induction of anesthesia during intraoperative period
Change to intubation
Time Frame: Induction of anesthesia during intraoperative period
Conversion rate from insertion of i-gel™ to tracheal intubation.
Induction of anesthesia during intraoperative period
Blood staining after extubation
Time Frame: Induction of anesthesia during intraoperative period
Blood stating to evaluate the postoperative complication and outcome in patients received each intubation method during surgery
Induction of anesthesia during intraoperative period
Sore throat after extubation
Time Frame: Extubation during intraoperative period
Sore throat to evaluate the postoperative complication and outcome in patients received each intubation method during surgery
Extubation during intraoperative period
Hoarseness after extubation
Time Frame: Extubation during intraoperative period
Hoarseness to evaluate the postoperative complication and outcome in patients received each intubation method during surgery
Extubation during intraoperative period
Sore throat at 24 hours after surgery
Time Frame: 24 hours after surgery (up to 24hours)
Sore throat to evaluate the postoperative complication and outcome in patients received each intubation method during surgery
24 hours after surgery (up to 24hours)
Hoarseness at 24 hours after surgery
Time Frame: 24 hours after surgery (up to 24hours)
Hoarseness to evaluate the postoperative complication and outcome in patients received each intubation method during surgery
24 hours after surgery (up to 24hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Karam Nam, MD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 2, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 2, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LMA_HNRotation

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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