NCT05201339

Brief Summary

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™.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

February 25, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2023

Completed
Last Updated

October 3, 2024

Status Verified

October 1, 2024

Enrollment Period

1.3 years

First QC Date

December 21, 2021

Last Update Submit

October 1, 2024

Conditions

Supraglottic Airway DeviceIntubation; Difficult or FailedAirway Complication of Anesthesia

Keywords

Supraglottic airway deviceIntubationAirway

Outcome Measures

Primary Outcomes (1)

  • First attempt success rate

    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 Outcomes (12)

  • Second attempt success rate

    Induction of anesthesia during intraoperative period

  • Insertion time for successful insertion; s

    Induction of anesthesia during intraoperative period

  • Time required for successful insertion; s

    Induction of anesthesia during intraoperative period

  • Third attempt

    Induction of anesthesia during intraoperative period

  • Third attempt success rate

    Induction of anesthesia during intraoperative period

  • +7 more secondary outcomes

Study Arms (2)

Standard method

ACTIVE COMPARATOR

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

Head-neck rotation

EXPERIMENTAL

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

Interventions

Standard methodPROCEDURE

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.

Standard method
Hean and Neck RotationPROCEDURE

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.

Head-neck rotation

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

Location

Related Publications (1)

  • Lee S, Nam K, Park SJ, Ju JW, Cho YJ, Jeon Y. Comparison between head rotation and standard techniques for i-gel insertion: a randomized controlled trial. BMC Anesthesiol. 2024 Jul 10;24(1):229. doi: 10.1186/s12871-024-02621-7.

    PMID: 38987667DERIVED

Study Officials

  • Karam Nam, MD

    Seoul National University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Seoul National University Hospital

Study Record Dates

First Submitted

December 21, 2021

First Posted

January 21, 2022

Study Start

February 25, 2022

Primary Completion

June 2, 2023

Study Completion

June 2, 2023

Last Updated

October 3, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)