An interventional study of Air-Q Intubating Airway and proseal laryngeal mask in Postoperative Complications and Sore Throat, sponsored by Diskapi Yildirim Beyazit Education and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 65 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Diskapi Yildirim Beyazit Education and Research Hospital · Not applicable, Interventional, and Prevention
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.
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.
1,332 studies on the registry are indexed under Postoperative Complications; 311 are open to participants now.
This study's enrollment of 97 is below the median of 114 across 766 interventional studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Diskapi Yildirim Beyazit Education and Research Hospital is the lead sponsor of 71 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
under general anesthesia, patients inserted Air- Q intubating airway.
Other: Air-Q Intubating Airway
under general anesthesia, patients inserted proseal laryngeal mask.
Other: proseal laryngeal mask
Patients will be inserted Air-Q Intubating Airway under general anesthesia
Patients will be inserted proseal laryngeal mask under general anesthesia.
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.
Time frame: One minute after successful LMA placement
SP Air-Q and proseal LMA insertion time
Successful LMA placement will be confirmed by visualizing a square waveform on the ventilator and observing chest wall movement.
Time frame: 3 minutes after induction of anesthesia
ease of LMA placement
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).
Time frame: 3 minutes after induction of anesthesia
maneuvers required for successful ventilation
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.
Time frame: 3 minutes after induction of anesthesia
fiberoptic view grading
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.
Time frame: 3 minutes after induction of anesthesia
Complications during SP_Air-Q and propseal LMA removal (emerge)
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.
Time frame: One minute after SP Air-Q removal
Sore throat
The presence or absence of sore throat will be recorded at the firsth postoperative hour.
Time frame: 1 hour postoperatively
Sore throat
The presence or absence of sore throat will be recorded at the 24th postoperative hour
Time frame: 24 hours postoperatively
dysphonia
The presence or absence of dysphonia will be recorded at the firsth postoperative hour
Time frame: 1 hour postoperatively
dysphonia
The presence or absence of dysphonia will be recorded at the 24th postoperative hour.
Time frame: 24 hours postoperatively
Plan to share: No
Ran from Nov 2024 to primary completion in Mar 2025, 4 months.
Of 391 non-industry interventional studies with no phase under Postoperative Complications, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 44. This study's 4 months is below that.
Counting every sponsor, half of 395 studies reached it within 21 months; a quarter within 8 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Diskapi Yildirim Beyazit Education and Research Hospital