NCT06677567

Brief Summary

Aged- related changes in upper airway anatomy may affect the overall performance of supraglottic airways significantly. In this study, investigator aim to compare the clinical performance, efficacy, and associated complications of the Proseal Laryngeal Mask and the Air-Q Intubation Laryngeal Airway in elderly patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

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

November 5, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

November 10, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2025

Completed
Last Updated

May 27, 2026

Status Verified

May 1, 2026

Enrollment Period

4 months

First QC Date

November 5, 2024

Last Update Submit

May 22, 2026

Conditions

Postoperative ComplicationsSore Throat

Keywords

Air-Q SP Laryngeal İntubating AirwayOropharyngeal leak pressureproseal larygeal masksupraglottic airways

Outcome Measures

Primary Outcomes (1)

  • Measurement of oropharyngeal leak pressure (OLP)

    One minute after successful LMA placement and fixation, oropharyngeal leak pressure (OLP) will be measured by setting the adjustable pressure limiting valve (APL) to 40 mmHg and maintaining a fresh gas flow of 3 L/min. The OLP will be recorded as the pressure at which an audible leak sound is heard from the mouth.

    One minute after successful LMA placement

Secondary Outcomes (1)

  • SP Air-Q and proseal LMA insertion time

    3 minutes after induction of anesthesia

Other Outcomes (8)

  • ease of LMA placement

    3 minutes after induction of anesthesia

  • maneuvers required for successful ventilation

    3 minutes after induction of anesthesia

  • fiberoptic view grading

    3 minutes after induction of anesthesia

  • +5 more other outcomes

Study Arms (2)

SP AİR Q group

OTHER

under general anesthesia, patients inserted Air- Q intubating airway.

Other: Air-Q Intubating Airway

Proseal Group

OTHER

under general anesthesia, patients inserted proseal laryngeal mask.

Other: proseal laryngeal mask

Interventions

Air-Q Intubating AirwayOTHER

Patients will be inserted Air-Q Intubating Airway under general anesthesia

SP AİR Q group
proseal laryngeal maskOTHER

Patients will be inserted proseal laryngeal mask under general anesthesia.

Proseal Group

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • year-old patients
  • American Society of Anesthesiologist Physical Status classification I-III,
  • Undergoing an elective operation under general anesthesia in our hospital

You may not qualify if:

  • Predicted difficult airway (Mallampati class 4, mouth opening \< 3 cm, or thyromental distance \< 6 cm)
  • body mass index (BMI) \> 40 kg/m2
  • Patients with a high risk of aspiration (e.g., history of gastrectomy, -gastroesophageal reflux disease, or hiatal hernia),
  • Unstable vital signs
  • Cervical spine problems, Respiratory complications (e.g. recent pneumonia).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zeynep Koç

Yenimahalle, Ankara, Turkey (Türkiye)

Location

Related Publications (4)

  • Kim EM, Kim MS, Koo BN, Lee JR, Lee YS, Lee JH. Clinical efficacy of the classic laryngeal mask airway in elderly patients: a comparison with young adult patients. Korean J Anesthesiol. 2015 Dec;68(6):568-74. doi: 10.4097/kjae.2015.68.6.568. Epub 2015 Nov 25.

    PMID: 26634080BACKGROUND

  • In CB, Cho SA, Lee SJ, Sung TY, Cho CK. Comparison of the clinical performance of airway management with the i-gel(R) and laryngeal mask airway SupremeTM in geriatric patients: a prospective and randomized study. Korean J Anesthesiol. 2019 Feb;72(1):39-46. doi: 10.4097/kja.d.18.00121. Epub 2018 Oct 22.

    PMID: 30343563RESULT

  • Lee JS, Kim DH, Choi SH, Ha SH, Kim S, Kim MS. Prospective, Randomized Comparison of the i-gel and the Self-Pressurized air-Q Intubating Laryngeal Airway in Elderly Anesthetized Patients. Anesth Analg. 2020 Feb;130(2):480-487. doi: 10.1213/ANE.0000000000003849.

    PMID: 30320644RESULT

  • Wahba RM, Ragaei MZ, Metry AA, Nakhla GM. Supraglottic Airway Devices for Elective Pediatric Anesthesia: I-gel versus Air-Q, Which is the Best? Anesth Essays Res. 2020 Jul-Sep;14(3):461-466. doi: 10.4103/aer.AER_107_20. Epub 2021 Mar 22.

    PMID: 34092859RESULT

MeSH Terms

Conditions

Postoperative ComplicationsPharyngitis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 5, 2024

First Posted

November 6, 2024

Study Start

November 10, 2024

Primary Completion

March 10, 2025

Study Completion

April 10, 2025

Last Updated

May 27, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)