Clinical trial NCT06602817: I-gel Plus Supraglottic Airway Device for Surgical Procedures in Prone Position
Official title: The I-gel Plus Supraglottic Airway Device for Elective Surgical Procedures in Prone Position
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: General Anesthesia
Airway Management
Supraglottic Airway
Keywords: Prone position
Surgery
Airway management
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 28
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 surgery in prone position with i-gel Plus used for airway management

Brief summary: I-gel Plus is a novel supraglottic airway device that has been evaluated in various studies with high success and low complication rates. Feasibility of supraglottic airway devices (SGA) in patients undergoing surgery in prone position has been demonstrated in some pilot studies and case series; however, the evidence is still limited. It is currently uncertain, if the i-gel Plus facilitates appropriate ventilation in individuals undergoing elective surgery in prone position.

The primary aim of this single-center non-inferior study is to assess the leak fraction of the i-gel Plus in patients undergoing surgery in prone position and to compare it with data from an existing prospective control cohort in patients undergoing surgery in supine position. Secondary aims are to investigate the oropharyngeal seal pressure and other secondary outcome parameters and to compare them with the control cohort.


Eligibility criteria: Inclusion Criteria:

* Patients scheduling for elective surgery in prone position
* 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
* Shared airway or intracavity open surgery
* Body mass index (BMI) \&amp;gt;35 kg/m2
* Inability to understand or sign informed consent

Primary outcomes:
measure: Leak fraction
timeFrame: 3 hours
Secondary outcomes:
measure: Oropharyngeal seal pressure [cm H2O]
timeFrame: 3 hours
measure: Leakage volume (ml)
timeFrame: 3 hours
measure: Tidal volume (ml)
timeFrame: 3 hours
measure: Inspiratory peak pressure (cm H2O)
timeFrame: 3 hours
measure: Positive endexpiratory pressure (PEEP) (cm H2O)
timeFrame: 3 hours
measure: Respiratory rate (1/min)
timeFrame: 3 hours
measure: Minute ventilation (l/min/kg)
timeFrame: 3 hours
measure: Endtidal CO2 [mmHg]
timeFrame: 3 hours
measure: Number of insertion attempts
timeFrame: 3 hours
measure: Insertion success rate (%)
timeFrame: 3 hours
measure: First-attempt insertion success rate (%)
timeFrame: 3 hours
measure: Necessity of adjustment maneuvers during the procedure
timeFrame: 3 hours
measure: Insertion time (sec)
timeFrame: 3 hours
measure: Lowest oxygen saturation (%)
timeFrame: 3 hours
measure: Difficulty of insertion
timeFrame: 3 hours
measure: Ease of gastric tube insertion
timeFrame: 3 hours
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: University Medical Center Hamburg-Eppendorf: Universitatsklinikum Hamburg-Eppendorf
name: Martin Petzoldt, MD
role: PRINCIPAL_INVESTIGATOR
References: