Clinical trial NCT06677567: Air-Q and Proseal Laryngeal Mask in Elderly Patients
Official title: Comparison of the Efficacy of Self-Pressurizing Air-Q Intubation Laryngeal Airway and Proseal Laryngeal Mask in Elderly Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Postoperative Complications
Sore Throat
Keywords: Air-Q Laryngeal İntubating Airway
Oropharyngeal leak pressure
proseal larygeal mask
supraglottic airways
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-11-06
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Measurement of oropharyngeal leak pressure (OLP)
timeFrame: One minute after successful LMA placement
Secondary outcomes:
measure: SP Air-Q and proseal LMA insertion time
timeFrame: 3 minutes after induction of anesthesia
Other outcomes:
measure: ease of LMA placement
timeFrame: 3 minutes after induction of anesthesia
measure: maneuvers required for successful ventilation
timeFrame: 3 minutes after induction of anesthesia
measure: fiberoptic view grading
timeFrame: 3 minutes after induction of anesthesia
measure: Complications during SP_Air-Q and propseal LMA removal (emerge)
timeFrame: One minute after SP Air-Q removal
measure: Sore throat
timeFrame: 1 hours postoperatively
measure: Sore throat
timeFrame: 24 hours postoperatively
measure: dysphonia
timeFrame: 1 hours postoperatively
measure: dysphonia
timeFrame: 24 hours postoperatively
Locations:
city: Yenimahalle
country: Turkey
facility: Zeynep Koç
state: Ankara
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.