General AnesthesiaNCT06602817
I-gel Plus Supraglottic Airway Device for Surgical Procedures in Prone Position
An observational study of General Anesthesia and Airway Management, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- General Anesthesia, Airway Management, Supraglottic Airway
- What is being tested?
- Exposure: prone position and Exposure: Supine position
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2024to 4 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing elective surgery in prone position with i-gel Plus used for airway management
Who may be able to join
- 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
Who cannot join
- 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) \>35 kg/m2
- Inability to understand or sign informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical-Center Hamburg Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
About this study
Official title: The I-gel Plus Supraglottic Airway Device for Elective Surgical Procedures in Prone Position
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.
- Conditions
- General Anesthesia, Airway Management, Supraglottic Airway
- Being tested
- Exposure: prone position, Exposure: Supine position
- Keywords
- Prone position, Surgery, Airway management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure: prone positionOther
Exposure: surgery in prone position
Exposure: Supine positionOther
Exposure: Surgery in supine position
| Study group | Role | What they receive |
|---|---|---|
| Surgery in prone position | Patients undergoing elective surgery in prone position with i-gel Plus used for airway management Receives: Other: Exposure: prone position | |
| Surgery in supine position | Existing prospective control cohort with patients undergoing elective surgery in supine position with i-gel Plus used for airway management Receives: Other: Exposure: Supine position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leak fraction
Ventilation parameter - Leakage volume per tidal volume
Measured: 3 hours
Secondary outcomes (18)
Oropharyngeal seal pressure [cm H2O]
Clinical assessment - leak pressure with audible leak
Measured: 3 hours
Leakage volume (ml)
Ventilation parameter - as displayed on the ventilator
Measured: 3 hours
Tidal volume (ml)
Ventilation parameter - as displayed on the ventilator
Measured: 3 hours
Inspiratory peak pressure (cm H2O)
Ventilation parameter - as displayed on the ventilator
Measured: 3 hours
Positive endexpiratory pressure (PEEP) (cm H2O)
Ventilation parameter - as displayed on the ventilator
Measured: 3 hours
Respiratory rate (1/min)
Ventilation parameter - as displayed on the ventilator
Measured: 3 hours
Minute ventilation (l/min/kg)
Ventilation parameter -as displayed on the ventilator
Measured: 3 hours
Endtidal CO2 [mmHg]
Ventilation parameter - as displayed on the ventilator
Measured: 3 hours
Number of insertion attempts
Clinical assessment - SGA insertion attempts
Measured: 3 hours
Insertion success rate (%)
Clinical assessment
Measured: 3 hours
First-attempt insertion success rate (%)
Clinical assessment - successful placement in only one insertion attempt
Measured: 3 hours
Necessity of adjustment maneuvers during the procedure
Clinical assessment
Measured: 3 hours
Insertion time (sec)
Clinical assessment
Measured: 3 hours
Lowest oxygen saturation (%)
Measured by pulse oximetry
Measured: 3 hours
Difficulty of insertion
Clinical assessment on a scale between 1-5
Measured: 3 hours
Ease of gastric tube insertion
Clinical assessment - rating on a scale from 1-5
Measured: 3 hours
Postoperative complications
Clinical assessment
Measured: 24 hours postoperatively
Complications at the end of surgery
Clinical assessment
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024
- Primary completion4 Feb 2025
- Study completion4 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Petzoldt, MD, Principal investigator, University Medical Center Hamburg-Eppendorf: Universitatsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602817
- Sponsor's protocol ID
- 2024-101343-BO-ff
- Status last verified
- Jun 2025
- First submitted
- 16 Sep 2024
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The I-gel Plus Supraglottic Airway Device for Elective Surgical Procedures in Prone Position
- ClinicalTrials.gov ID
- NCT06602817
- Acronym / sponsor ID
- 2024-101343-BO-ff
- Conditions
- General Anesthesia, Airway Management, Supraglottic Airway
- Keywords
- Prone position, Surgery, Airway management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 4 Feb 2025 (actual)
- Study completion
- 4 Feb 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery in prone position | – | Other: Exposure: prone positionPatients undergoing elective surgery in prone position with i-gel Plus used for airway management |
| Surgery in supine position | – | Other: Exposure: Supine positionExisting prospective control cohort with patients undergoing elective surgery in supine position with i-gel Plus used for airway management |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing elective surgery in prone position with i-gel Plus used for airway management
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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) \>35 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure: prone positionExposure: surgery in prone position | Other | Surgery in prone position |
| Exposure: Supine positionExposure: Surgery in supine position | Other | Surgery in supine position |
Primary outcome
Leak fraction
Time frame: 3 hours
Ventilation parameter - Leakage volume per tidal volume
18 secondary outcomes
Oropharyngeal seal pressure [cm H2O]
Time frame: 3 hours
Leakage volume (ml)
Time frame: 3 hours
Tidal volume (ml)
Time frame: 3 hours
Inspiratory peak pressure (cm H2O)
Time frame: 3 hours
Positive endexpiratory pressure (PEEP) (cm H2O)
Time frame: 3 hours
Respiratory rate (1/min)
Time frame: 3 hours
Minute ventilation (l/min/kg)
Time frame: 3 hours
Endtidal CO2 [mmHg]
Time frame: 3 hours
Number of insertion attempts
Time frame: 3 hours
Insertion success rate (%)
Time frame: 3 hours
First-attempt insertion success rate (%)
Time frame: 3 hours
Necessity of adjustment maneuvers during the procedure
Time frame: 3 hours
Insertion time (sec)
Time frame: 3 hours
Lowest oxygen saturation (%)
Time frame: 3 hours
Difficulty of insertion
Time frame: 3 hours
Ease of gastric tube insertion
Time frame: 3 hours
Postoperative complications
Time frame: 24 hours postoperatively
Complications at the end of surgery
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Petzoldt, MD principal investigator
University Medical Center Hamburg-Eppendorf: Universitatsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Anesthesia and Airway Management, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leak fraction (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.