Clinical trial NCT06602830: I-gel Plus Supraglottic Airway Device for Elective Laparoscopic Surgery
Official title: I-gel Plus Supraglottic Airway Device for Elective Laparoscopic Surgery -a Prospective Observational Study-
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Management
Supraglottic Airway
General Anesthesia
Laparoscopic Surgery
Keywords: Airwaymanagement
Laparoscopic surgery
Capnoperitoneum
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective laparoscopic surgery with i-gel Plus used for airway management

Brief summary: i-gel Plus is a novel supraglottic airway device (SGA). Feasibility of second-generation SGAs in patients undergoing elective laparoscopic surgery has been demonstrated in various studies. During laparoscopic surgery intrabdominal pressure is increased by capnoperitoneum and frequently minute ventilation has to be adopted to counteract hypercapnia, and higher inspiratory peak pressures have to be expected. It is uncertain, however, if the i-gel Plus facilitates appropriate ventilation with low leakage volumes in patients undergoing laparoscopic surgery.

The primary aim of this single-center non-inferiority study is to assess the leak fraction of the i-gel Plus under conditions of capnoperitoneum (with and without Trendelenburg position) and to compare it with baseline conditions. Secondary aims are to assess secondary outcome parameters during capnoperitoneum (with and without Trendelenburg position) and to compare them with baseline conditions.


Eligibility criteria: Inclusion Criteria:

* Patients scheduling for elective laparoscopic surgery
* Planned airway management using a SGA
* Adult patients (age 18-89 years)
* ASA physical status 1-3

Exclusion Criteria:

* Pregnant or breastfeeding women
* Non-fasted patients
* Increased risk of aspiration or other contraindications for supraglottic mask ventilation
* Body mass index (BMI) \>35 kg/m2
* Inability to understand or sign informed consent

Primary outcomes:
measure: Leak fraction
timeFrame: 3 houres
Secondary outcomes:
measure: Oropharyngeal seal pressure [cm H2O]
timeFrame: 3 houres
measure: Leakage volume (ml)
timeFrame: 3 houres
measure: Tidal volume (ml)
timeFrame: 3 houres
measure: Inspiratory peak pressure (cm H2O)
timeFrame: 3 houres
measure: Positive endexpiratory pressure (PEEP) (cm H2O)
timeFrame: 3 houres
measure: Intraabdominal pressure under capnoperitoneum [mmHg]
timeFrame: 3 houres
measure: Respiratory rate (1/min)
timeFrame: 3 houres
measure: Minute ventilation (l/min/kg)
timeFrame: 3 houres
measure: Endtidal CO2 [mmHg]
timeFrame: 3 houres
measure: Number of insertion attempts
timeFrame: 3 houres
measure: Insertion success rate (%)
timeFrame: 3 houres
measure: First-attempt insertion success rate (%)
timeFrame: 3 houres
measure: Necessity of adjustment maneuvers during the procedure
timeFrame: 3 houres
measure: Insertion time (sec)
timeFrame: 3 houres
measure: Lowest oxygen saturation (%)
timeFrame: 3 houres
measure: Difficulty of insertion
timeFrame: 3 houres
measure: Ease of gastric tube insertion
timeFrame: 3 houres
measure: Postoperative complications
timeFrame: 24 hours postoperatively
measure: Complications at the end of surgery
timeFrame: 3 hours
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Martin Petzoldt, MD
role: PRINCIPAL_INVESTIGATOR
References: