Gastric InsufflationNCT06853756
Gastric Insufflation Volume Using I-gel Versus Ambu AuraGain in Pediatric Patients Undergoing Elective Orthopedic Operations Under General Anesthesia
A study testing Ambu Auragain and I-gel in people with Gastric Insufflation and I-gel, run by Tanta University at 1 site in Egypt.
Trial summary
Our study aimed to compare the gastric insufflation volume between Ambu AuraGain and i-gel and its relationship with the oropharyngeal sealing pressure and the incidence of postoperative complications in generally anesthetized controlled-ventilated pediatric patients undergoing elective orthopedic operations. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Gastric Insufflation, I-gel, Ambu AuraGain
- What is being tested?
- Ambu Auragain and I-gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 27 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged from 2 to 12 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I and II.
- Scheduled for elective orthopedic operations in a supine position under general anesthesia.
Who cannot join
- Patients with a known history of gastro-oesophageal reflux disorders.
- Full Stomach.
- Anticipated difficult mask ventilation or intubation.
- Body mass index "BMI" exceeding 20% of the ideal.
- A history of chest problems.
- History of the gastrointestinal tract or thoracic surgeries.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Aya N Farahat, MBBCH, 00201552122249, aya.nabil311.nabil@gmail.com
Kamal E Hikel, MD
About this study
Official title: Gastric Insufflation Volume Using I-gel Versus Ambu AuraGain in Pediatric Patients Undergoing Elective Orthopedic Operations Under General Anesthesia: a Prospective Randomized Trial
Our study aimed to compare the gastric insufflation volume between Ambu AuraGain and i-gel and its relationship with the oropharyngeal sealing pressure and the incidence of postoperative complications in generally anesthetized controlled-ventilated pediatric patients undergoing elective orthopedic operations.
Read the detailed description
Supraglottic Airway Devices (SADs) refer to a wide range of medical devices that can act as a passageway for oxygenation, ventilation, and administration of anesthetic gases and may be deemed an alternative to Endotracheal Tubes (ETTs).
Oropharyngeal sealing pressure (OLP) provides insight into the risk of gastric insufflation and aspiration risk. It is considered a measure of adequate performance and successful placement based on the premise that the SAD is sited properly in the hypopharynx after blind placements, and it is a useful comparator between SADs.
- Conditions
- Gastric Insufflation, I-gel, Ambu AuraGain, Pediatric, Orthopedic Operations, General Anesthesia
- Being tested
- Ambu Auragain, I-gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambu AuragainDevice
Ambu Auragain was inserted after induction.
I-gelDevice
The I-gel device was inserted after induction.
| Study group | Role | What they receive |
|---|---|---|
| Ambu Auragain group | Experimental | Ambu Auragain was inserted after induction. Receives: Device: Ambu Auragain |
| I-gel group | Experimental | The I-gel device was inserted after induction. Receives: Device: I-gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric antrum cross-sectional area (CSA)
Gastric antrum cross-sectional area (CSA) was measured before induction of general anesthesia, before supraglottic airway devices (SAD) insertion, after Ryle's tube insertion, and at the end of surgery before SAD removal.
Measured: At the end of surgery before supraglottic airway devices removal (5 min)
Secondary outcomes (4)
Oropharyngeal leak pressure
Oropharyngeal leak pressure was determined after confirmation of adequate device insertion and secure taping by closing the adjustable pressure-limiting (APL) valve with a fresh gas flow of 3 l/min and observing the airway pressure at which equilibrium was attained in the aneroid manometer (airway pressure was not allowed to exceed 40cmH2O) or when there was audible air leak from the throat which was auscultated in the neck with a stethoscope placed just beside the thyroid cartilage.
Measured: Intraoperatively
Time of insertion of supraglottic airway devices
Insertion time was measured in seconds and counted from the time of opening the jaw to the appearance of the capnography waveform.
Measured: Intraoperatively
Number of attempts for insertion
Three insertion attempts were allowed. Each 'attempt' was defined as reinsertion of the airway device into the mouth. Insertion failure of the device was defined as greater than three unsuccessful attempts or if the entire process of insertion exceeded 120 seconds.
Measured: Intraoperatively
Incidence of postoperative complications
Incidence of postoperative complications such as mucosal injury, laryngeal spasm, hoarseness, nausea and vomiting were recorded.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start1 Aug 2023
- Primary completion27 Mar 2025 (estimated)
- Study completion27 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric InsufflationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Nabil Farahat, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853756
- Sponsor's protocol ID
- 36264MS287/8/23
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Insufflation Volume Using I-gel Versus Ambu AuraGain in Pediatric Patients Undergoing Elective Orthopedic Operations Under General Anesthesia: a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT06853756
- Acronym / sponsor ID
- 36264MS287/8/23
- Conditions
- Gastric Insufflation, I-gel, Ambu AuraGain, Pediatric, Orthopedic Operations, General Anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 27 Mar 2025 (estimated)
- Study completion
- 27 Mar 2025 (estimated)
- First posted
- 3 Mar 2025 (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.
Our study aimed to compare the gastric insufflation volume between Ambu AuraGain and i-gel and its relationship with the oropharyngeal sealing pressure and the incidence of postoperative complications in generally anesthetized controlled-ventilated pediatric patients undergoing elective orthopedic operations.
Detailed description
Supraglottic Airway Devices (SADs) refer to a wide range of medical devices that can act as a passageway for oxygenation, ventilation, and administration of anesthetic gases and may be deemed an alternative to Endotracheal Tubes (ETTs).
Oropharyngeal sealing pressure (OLP) provides insight into the risk of gastric insufflation and aspiration risk. It is considered a measure of adequate performance and successful placement based on the premise that the SAD is sited properly in the hypopharynx after blind placements, and it is a useful comparator between SADs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambu Auragain group | Experimental | Device: Ambu AuragainAmbu Auragain was inserted after induction. |
| I-gel group | Experimental | Device: I-gelThe I-gel device was inserted after induction. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged from 2 to 12 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I and II.
- Scheduled for elective orthopedic operations in a supine position under general anesthesia.
Key exclusion criteria (6 listed)
- Patients with a known history of gastro-oesophageal reflux disorders.
- Full Stomach.
- Anticipated difficult mask ventilation or intubation.
- Body mass index "BMI" exceeding 20% of the ideal.
- A history of chest problems.
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 |
|---|---|---|
| Ambu AuragainAmbu Auragain was inserted after induction. | Device | Ambu Auragain group |
| I-gelThe I-gel device was inserted after induction. | Device | I-gel group |
Primary outcome
Gastric antrum cross-sectional area (CSA)
Time frame: At the end of surgery before supraglottic airway devices removal (5 min)
Gastric antrum cross-sectional area (CSA) was measured before induction of general anesthesia, before supraglottic airway devices (SAD) insertion, after Ryle's tube insertion, and at the end of surgery before SAD removal.
4 secondary outcomes
Oropharyngeal leak pressure
Time frame: Intraoperatively
Time of insertion of supraglottic airway devices
Time frame: Intraoperatively
Number of attempts for insertion
Time frame: Intraoperatively
Incidence of postoperative complications
Time frame: 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Gastric Insufflation
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Comparison of Two Airway Devices (I-Gel and Air-Q) in Children Aged 1-10 Years During General Anesthesia
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambu Auragain and I-gel in people with Gastric Insufflation and I-gel, run by Tanta University at 1 site in Egypt.
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: looking for participants now, as of the sponsor's last update on 3 Mar 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aya N Farahat, MBBCH (00201552122249, aya.nabil311.nabil@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric antrum cross-sectional area (CSA) (time frame: At the end of surgery before supraglottic airway devices removal (5 min)). 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 3 Mar 2025.