Air-Q and Proseal Laryngeal Mask in Elderly Patients

NCT06677567 | Not Yet Recruiting

• 1 other identifier: ZeynepKoc003
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications; Sore Throat

Keywords

Air-Q Laryngeal İntubating Airway; Oropharyngeal leak pressure; proseal larygeal mask; supraglottic 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

Study Arms (2)

SP AİR Q group

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

Other: Air-Q Intubating Airway

Proseal Group

under general anesthesia, patients inserted proseal laryngeal mask.

Other: proseal laryngeal mask

Interventions

Air-Q Intubating Airway OTHER

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

SP AİR Q group

proseal laryngeal mask OTHER

Patients will be inserted proseal laryngeal mask under general anesthesia.

Proseal Group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

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).

Sponsors & Collaborators

• Diskapi Yildirim Beyazit Education and Research Hospital: lead

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: 26634080 BACKGROUND

• 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: 30343563 RESULT

• 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: 30320644 RESULT

• 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: 34092859 RESULT

MeSH Terms

Conditions

Postoperative Complications; Pharyngitis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Zeynep Koc

CONTACT

+905345958843; zeynepyilmazkoc@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• 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: January 10, 2025
• Study Completion: January 20, 2025
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)