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LMA Protector vs I-Gel in Low-Flow Anesthesia for Laparoscopic Cholecystectomy

11. juli 2026 opdateret af: Ahmet Emre Akın, Fatih Sultan Mehmet Training and Research Hospital

Comparison of LMA Protector and I-Gel Use in Low-Flow Anesthesia for Laparoscopic Cholecystectomy: A Prospective Randomized Study

This prospective randomized study aims to compare two second-generation supraglottic airway devices (SGAs), the I-Gel and the laryngeal mask airway (LMA) Protector, in patients undergoing laparoscopic cholecystectomy under low-flow desflurane anesthesia. The study evaluates the devices in terms of respiratory mechanics (dynamic compliance, peak inspiratory pressure, plateau pressure, and airway resistance), non-invasive perfusion parameters (oxygen reserve index, perfusion index, and pleth variability index), hemodynamic stability, ease of insertion, oropharyngeal leak pressure, and postoperative complication rates.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Sixty-two patients (ASA I-II, aged 18-65 years) scheduled for elective laparoscopic cholecystectomy were randomized into two groups: Group I (I-Gel) and Group P (LMA Protector). General anesthesia induction was standardized, and maintenance was provided with desflurane at a fresh gas flow of 1 L/min to achieve low-flow anesthesia. Peak inspiratory pressure (PIP), plateau pressure (Pplato), dynamic compliance (Cdyn), and airway resistance were recorded at six distinct intraoperative time points: 5 minutes after SGA insertion (T1), 1 minute after pneumoperitoneum insufflation (T2), 1 minute after the 30-degree reverse Trendelenburg position (T3), 10 minutes after insufflation (T4), 1 minute after desufflation (T5), and immediately before SGA removal (T6). Oropharyngeal leak pressure (OLP) was measured after insertion and before removal. Postoperative complications such as sore throat, cough, hoarseness, dysphagia, and nausea-vomiting were monitored postoperatively.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

62

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyrkiet (Türkiye)
      • Istanbul, Tyrkiet (Türkiye), 34752
        • Fatih Sultan Mehmet Training and Research Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Patients aged 18-65 years
  • American Society of Anesthesiologists (ASA) physical status I or II
  • Scheduled for elective laparoscopic cholecystectomy

Exclusion Criteria:

  • Known or predicted difficult airway or history of difficult intubation
  • Body Mass Index (BMI) greater than 35 kg/m²
  • High risk of gastroesophageal reflux or aspiration
  • Severe cardiac, respiratory, renal, or hepatic disease
  • Pregnancy
  • Patient refusal to participate

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group I: I-Gel
Patients managed with the I-Gel supraglottic airway device during low-flow desflurane anesthesia for laparoscopic cholecystectomy.
Enhed: I-Gel supraglottic airway
Placement of an appropriate size of i-gel supraglottic airway device for airway management during general anesthesia. Anesthesia maintenance is provided with desflurane in a fresh gas flow of 1 L/min (low-flow anesthesia).
Andre navne:
  • i-gel
Eksperimentel: Group P: LMA Protector
Patients managed with the LMA Protector supraglottic airway device during low-flow desflurane anesthesia for laparoscopic cholecystectomy.
Enhed: LMA Protector supraglottic airway
Placement of an appropriate size of LMA Protector supraglottic airway device for airway management during general anesthesia. Anesthesia maintenance is provided with desflurane in a fresh gas flow of 1 L/min (low-flow anesthesia).
Andre navne:
  • Laryngeal Mask Airway Protector

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dynamic Lung Compliance (Cdyn)
Tidsramme: Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.
Dynamic compliance of the respiratory system, calculated automatically by the ventilator as tidal volume divided by (peak inspiratory pressure minus positive end-expiratory pressure).
Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Peak Inspiratory Pressure (PIP)
Tidsramme: Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.
Maximum airway pressure generated during the inspiratory phase, monitored to assess airway dynamics under general anesthesia.
Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.
Plateau Pressure (Pplateau)
Tidsramme: Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.
Pressure applied to the small airways and alveoli during a period of zero gas flow, monitored to assess risk of barotrauma.
Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.
Airway Resistance
Tidsramme: Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.
The resistance of the respiratory tract to airflow during mechanical ventilation, calculated using peak and plateau pressures.
Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Fatih Sultan Mehmet Training and Research Hospital

Samarbejdspartnere

Masimo Corporation

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juli 2020

Primær færdiggørelse (Faktiske)

31. oktober 2020

Studieafslutning (Faktiske)

31. oktober 2020

Datoer for studieregistrering

Først indsendt

5. juli 2026

Først indsendt, der opfyldte QC-kriterier

11. juli 2026

Først opslået (Faktiske)

16. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • FSM KAEK-2020/79

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Anæstesi, general

Kliniske forsøg med I-Gel supraglottic airway

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Betingelser

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Placeringer

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