Air-Q and Proseal Laryngeal Mask in Elderly Patients

May 22, 2026 updated by: Zeynep Koc, Diskapi Yildirim Beyazit Education and Research Hospital

Comparison of the Efficacy of Self-Pressurizing Air-Q Intubation Laryngeal Airway and Proseal Laryngeal Mask in Elderly Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Elderly patients are vulnerable to perioperative pulmonary complications during intubation and extubation. Supraglottic airway devices (SADs) have been utilized as a relatively easy method of airway management for resuscitation and difficult intubations and are used during elective general anesthesia with reduced airway complications compared to endotracheal intubation. SADs may help maintain hemodynamic stability as they require less anesthetic agents compared to endotracheal intubation. With aging, parapharyngeal fat accumulation increases, leading to pharyngeal collapse in elderly patients. Additionally, structural changes in the respiratory tract combined with physiological alterations in respiration may reduce oxygen saturation, blunt the hypoxic response, and increase postoperative respiratory complications. Acquired changes in pharyngeal muscle activity with age are thought to increase the likelihood of bony structural changes, such as retrognathia, which is typically considered a difficult airway. Therefore, these age-related changes may impact the clinical performance of SADs. ProSeal LMA is one of the most commonly used supraglottic airway devices in clinical practice. It was developed by modifying the classic LMA in the 2000s and features an inflatable cuff. Additionally, it has a gastric channel for gastric aspiration adjacent to the airway tube. Recently, SGAs (supraglottic airways) that do not require manual cuff inflation have been increasingly used in various clinical situations due to the advantages of eliminating manual cuff inflation and monitoring cuff pressure. Air-Q connects to an airway tube via a communication port that allows self-regulation of cuff pressure in response to airway pressure. 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.

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • 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 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

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Study Population

Patients aged 65 to 90 years, both male and female, classified as ASA 1-3, will be included in the study if they undergo surgery with ProSeal LMA and Air-Q intubating airway.

Description

Inclusion Criteria:

  • 65-90 year-old patients
  • American Society of Anesthesiologist Physical Status classification I-III,
  • Undergoing an elective operation under general anesthesia in our hospital

Exclusion Criteria:

  • 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).

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: SP AİR Q group
under general anesthesia, patients inserted Air- Q intubating airway.
Other: Air-Q Intubating Airway
Patients will be inserted Air-Q Intubating Airway under general anesthesia
Other: Proseal Group
under general anesthesia, patients inserted proseal laryngeal mask.
Other: proseal laryngeal mask
Patients will be inserted proseal laryngeal mask under general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of oropharyngeal leak pressure (OLP)
Time Frame: One minute after successful LMA placement
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
SP Air-Q and proseal LMA insertion time
Time Frame: 3 minutes after induction of anesthesia
Successful LMA placement will be confirmed by visualizing a square waveform on the ventilator and observing chest wall movement.
3 minutes after induction of anesthesia

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
maneuvers required for successful ventilation
Time Frame: 3 minutes after induction of anesthesia
It will be recorded whether any further maneuvers are required: Gentle pushing or pulling of the LMA to adjust its depth, jaw-thrust maneuver, and flexion or extension of the head.
3 minutes after induction of anesthesia
fiberoptic view grading
Time Frame: 3 minutes after induction of anesthesia
The Brimacombe score will be used to evaluate the view obtained with fiberoptic bronchoscopy. 1: Vocal cords are not visible; 2: Vocal cords and anterior epiglottis are visible; 3: Vocal cords and posterior epiglottis are visible; 4: Vocal cords are visible.
3 minutes after induction of anesthesia
ease of LMA placement
Time Frame: 3 minutes after induction of anesthesia
he ease of LMA placement will be scored by the anesthesiologist on a scale from 1 to 4 (1: Successful on the first attempt with no resistance from the tissues; 2: Successful on the first attempt but with some tissue resistance during placement; 3: Moderate tissue resistance; 4: Failure to place the LMA).
3 minutes after induction of anesthesia
Complications during SP_Air-Q and propseal LMA removal (emerge)
Time Frame: One minute after SP Air-Q removal
Complications during SP_Air-Q and proseal LMA removal (emerge) such as breath-holding during emergence, airway obstruction, coughing, hypoxia (SpO2 < 90%), vomiting, lip-tongue-teeth trauma, and bleeding, will be recorded.
One minute after SP Air-Q removal
Sore throat
Time Frame: 24 hours postoperatively
The presence or absence of sore throat will be recorded at the 24th postoperative hour
24 hours postoperatively
dysphonia
Time Frame: 24 hours postoperatively
The presence or absence of dysphonia will be recorded at the 24th postoperative hour.
24 hours postoperatively
dysphonia
Time Frame: 1 hour postoperatively
The presence or absence of dysphonia will be recorded at the firsth postoperative hour
1 hour postoperatively
Sore throat
Time Frame: 1 hour postoperatively
The presence or absence of sore throat will be recorded at the firsth postoperative hour.
1 hour postoperatively

Collaborators and Investigators

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

Sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 10, 2024

Primary Completion (Actual)

March 10, 2025

Study Completion (Actual)

April 10, 2025

Study Registration Dates

First Submitted

November 5, 2024

First Submitted That Met QC Criteria

November 5, 2024

First Posted (Actual)

November 6, 2024

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZeynepKoc003

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

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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