Comparison of Clinical Performance of Supraglottic Airway Devices

NCT06850675 | Completed

• 1 other identifier: 19-4.1T/40
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Abstract Aim: To compare the clinical performance and pharyngolaryngeal complications of two second-generation, supraglottic airway devices (SGAD), the I-gel and Laryngeal Mask Airway-Supreme (LMA-Supreme), in geriatric patients undergoing elective surgery under general anesthesia. Materials and Methods: After hospital ethics committee approval (19-4.1T/40- 17.04.2019) and written informed consent, patients aged 65 years and older, with an American Society of Anesthesiologists score of I-III, and who were scheduled for elective urological surgery under general anesthesia, were included prospectively. The patients were randomly divided into two equal sized groups, I-gel and LMA-supreme. The two groups were evaluated and compared for ease of supraglottic airway device insertion, time of insertion, success rate at first insertion, number of attempts, ease of gastric tube insertion, oropharyngeal leak pressure, and intraoperative and postoperative complications.

Conditions

Supraglottic Airway Devices; Geriatric Patient

Keywords

supraglottic airway device; I-gel; LMA-Supreme; geriatric patients; clinical performance

Outcome Measures

Primary Outcomes (4)

• The ease of insertion of supraglottic airway devices

  The ease of insertion was evaluated using a 3-point scale: 1=easy (the device was placed successfully on the first attempt without resistance and without the need for additional maneuvers); 2=difficult (the device was placed on the first attempt with slight resistance, requiring either upward or downward movement of the device or lifting of the chin); or 3=very difficult (placement was only achieved on the second attempt despite maneuvers).

  intraoperative period

• The time of insertion of supraglottic airway devices

  The placement time for the supraglottic airway devices is defined as the duration between the removal of the face mask and the observation of the first end tidal carbon dioxide waveform

  intraoperative period

• The ease of gastric tube insertion of supraglottic airway devices

  The number of attempts and the ease of gastric tube insertion were assessed also using a 3-point scale after lubricating the gastric tube and advancing it through the gastric channel following SGAD placement: 1=first attempt (successful insertion on the first try); 2=second attempt (successful insertion on the second try); or 3=failure (insertion was not successful

  intraoperative period

• oropharyngeal leak pressure of supraglottic airway devices

  Oropharyngeal leak pressure (OLP) was measured during the operation after the SGAD was properly positioned. Measurements were taken at 15-minute intervals throughout the procedure and at the end of the surgery, just before removing the SGAD. OLP was determined by observing the pressure at which air leaked from the mouth, utilizing a fixed fresh gas flow of 5 L/min. The expiratory (APL) valve was closed at 30 cmH2O to ensure that the peak airway pressure did not exceed 40 cmH2O. The assessment of OLP used a five-point scale: 1=excellent (no air leak at 30 cmH2O); 2=good (air leak at 18-20 cmH2O); 3=moderate (air leak at 10-16 cmH2O); 4=poor (air leak at ≤ 8 cmH2O); and 5=placement/ventilation failure

  intraoperative period

Secondary Outcomes (3)

• postoperative pharyngolaryngeal complications

  up to postoperative 12 hour

• postoperative pharyngolaryngeal complications

  up to postoperative 12 hour

• postoperative pharyngolaryngeal complications

  up to postoperative 12 hour

Study Arms (2)

group ı-gel

The patients participating in the study were randomly assigned to two groups

Other: Clinical performance

group lma-s

The patients participating in the study were randomly assigned to two groups

Other: Clinical performance

Interventions

Clinical performance OTHER

Supraglottic airway devices were evaluated for ease of insertion, time of insertion, success rate at first attempt, number of attempts, ease of gastric tube insertion, oropharyngeal leak pressure, and intraoperative and postoperative complications

group lma-s; group ı-gel

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients aged 65 and older, who all had an American Society of Anesthesiologists (ASA) score of I-III, and who were scheduled for elective urological surgery under general anesthesia were prospectively recruited.

You may qualify if:

• ≥65 age patients
• American Society of Anesthesiologists (ASA) score of I-III
• elective urological surgery

You may not qualify if:

• emergency surgery,
• unstable vital signs
• history of or suspicion of a difficult airway
• preoperative sore throat, or a high risk of aspiration
• body mass index ≥ 35 kg/m²
• gastroesophageal reflux
• hiatal hernia
• diabetic gastroparesis or a history of medications affecting gastrointestinal motility
• patients with a high risk of respiratory complications, such as those with asthma, chronic obstructive pulmonary disease, or recent pneumonia
• abnormalities of the oral cavity or pharynx,
• cervical spine issues,
• communication difficulties
• scheduled for surgeries lasting ≥ 90 minutes

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Medical Faculty Department of Anesthesiology and Reanimation

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

Related Publications (2)

• 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 RESULT

• Chen X, Jiao J, Cong X, Liu L, Wu X. A comparison of the performance of the I-gel vs. the LMA-Sduring anesthesia: a meta-analysis of randomized controlled trials. PLoS One. 2013 Aug 12;8(8):e71910. doi: 10.1371/journal.pone.0071910. eCollection 2013.

  PMID: 23951266 RESULT

Study Officials

• NURSEN KARACA, MEDİCAL DOCTOR

  Ege University Medical Faculty, Department of Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 27, 2025
• Study Start: April 17, 2019
• Primary Completion: April 17, 2020
• Study Completion: May 17, 2020
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

TU (1)