Air-Q and Proseal Laryngeal Mask in Elderly Patients

NCT ID: NCT06677567

Last Updated: 2024-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-10

Study Completion Date

2025-01-20

Brief Summary

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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

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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.

Conditions

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Postoperative Complications Sore Throat

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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SP AİR Q group

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

Air-Q Intubating Airway

Intervention Type OTHER

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

Proseal Group

under general anesthesia, patients inserted proseal laryngeal mask.

proseal laryngeal mask

Intervention Type OTHER

Patients will be inserted proseal laryngeal mask under general anesthesia.

Interventions

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Air-Q Intubating Airway

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

Intervention Type OTHER

proseal laryngeal mask

Patients will be inserted proseal laryngeal mask under general anesthesia.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diskapi Yildirim Beyazit Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Zeynep Koc

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zeynep Koç

Yenimahalle, Ankara, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Zeynep Koc

Role: CONTACT

+905345958843

References

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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.

Reference Type BACKGROUND
PMID: 26634080 (View on PubMed)

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.

Reference Type RESULT
PMID: 30343563 (View on PubMed)

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.

Reference Type RESULT
PMID: 30320644 (View on PubMed)

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.

Reference Type RESULT
PMID: 34092859 (View on PubMed)

Other Identifiers

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ZeynepKoc003

Identifier Type: -

Identifier Source: org_study_id

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