Airway Complication of AnesthesiaAuraGainLMANCT05106478
AuraGain Performance in Lateral Position
An observational study of Airway Complication of Anesthesia, run by Assiut University at 1 site in Egypt.
Trial summary
To compare the clinical performance of AuraGain including insertion time and success rate at first attempt, fiberoptic bronchoscopic view, oropharyngeal leak pressure, the degree of ease of gastric tube insertion, and peri-operative adverse effects in young children in supine, moderate lateral and extreme lateral… Read more about this study
- Who is it for?
- Ages 2 to 9 years
- Conditions the study is for
- Airway Complication of Anesthesia
- What is being tested?
- AuraGain
- Type of treatment
- Medical device
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2021to 29 Dec 2023
- 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 2 to 9 years
- All sexes
- No healthy volunteers
- Child
Study population: - children scheduled for elective outpatient surgery in which airway management with a® AuraGain would be appropriate.
Who may be able to join
- Weight: 15-30 kg.
- Age: 2-9 years.
- Sex: both males and females.
- ASA physical status: 1-3.
- Operation: elective outpatient surgery in which airway management with a® AuraGain would be appropriate.
Who cannot join
- Active respiratory illness (cough, fever, rhinorrhea) on the day of anesthesia,
- Potentially difficult airway.
- Patients with history of neck, respiratory, or digestive tract pathology.
- Patients with gastroesophageal reflux, gastrointestinal stenosis, or stricture.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Comparison of Pediatric® AuraGain in Supine, Moderate Lateral, and Extreme Lateral Positions in Terms of Clinical Performance and Fiber Optic Glottic
To compare the clinical performance of AuraGain including insertion time and success rate at first attempt, fiberoptic bronchoscopic view, oropharyngeal leak pressure, the degree of ease of gastric tube insertion, and peri-operative adverse effects in young children in supine, moderate lateral and extreme lateral position.
Read the detailed description
Ambu® AuraGain, a relatively novel supraglottic airway device, has been introduced recently. AuraGain has an inflatable cuff and a curved body. In addition, because the airway tube of AuraGain is wide, it can be used as a conduit for tracheal intubation. However, only a limited number of studies have been conducted on the performance of AuraGain in pediatric patients.
Changes in the position of the head and neck alter the shape of the pharynx leading to changes in the oropharyngeal leak pressure and the quality of ventilation through the LMA in both the adult and pediatric population. Having a large occiput and a relatively cephalically placed glottis, the ventilation in children is more compromised due to poor alignment of the pharyngeal-laryngeal axes during flexion of the head and neck. The hanging epiglottis covers the laryngeal inlet during flexion and the cuff of the LMA compresses the narrow laryngeal inlet both decreasing the delivered tidal volume. Different changes occur during extension and lateral rotation
Although the clinical performance of the AuraGain would be expected to be high, or at least non-inferior, to that of the widely used currently available SGAs, clinical trials are required to verify its performance in head and neck positions other than the neutral position (i.e flexion, extension and lateral rotation).
- Conditions
- Airway Complication of Anesthesia
- Being tested
- AuraGain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AuraGainDevice
Ambu® AuraGain, a relatively novel supraglottic airway device, has been introduced recently. AuraGain has an inflatable cuff and a curved body.
| Study group | Role | What they receive |
|---|---|---|
| Moderate lateral Group | Patients will be anesthetized using ® AuraGain airway that will be inserted lubricated with partially deflated cuff. After insertion, the cuff will be inflated with the recommended volume of air and operation will undergo while patient's neck in moderate lateral position. Receives: Device: AuraGain | |
| Extreme lateral Group | Patients will be anesthetized using ® AuraGain airway that will be inserted lubricated with partially deflated cuff. After insertion, the cuff will be inflated with the recommended volume of air and operation will undergo while patient's neck in extreme lateral position. Receives: Device: AuraGain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal leak pressure
Airway leak pressure will be determined by closing the adjustable expiratory pressure-limiting (APL) valve and setting the fresh gas flow rate to 3 L/min. The airway pressure at which an audible leak in the mouth is heard is recorded as the "leak Pressure".
Measured: Intraoperative from 1 minute after insertion of the device as a baseline to 60 minutes after insertion of the device
Secondary outcomes (2)
Ventilation score (grade 0, 1, 2 or 3),
the ventilation score which is scored from 0 to 3 based on three criteria: no leakage with an airway pressure of 15 cm H2O, bilateral chest excursions with a peak inspiratory pressure of 20 cm of H2O, and a square wave capnogram, with each item scoring 0 or 1 point . Thus, if all three criteria are satisfied, the ventilation score is 3.
Measured: Intraoperative from 1 minute after insertion of the device as baseline to 60 minutes after insertion of the device
Fiberoptic glottic view Score
The fiberoptic images will be graded with a score from 1 to 5, which has been defined and proposed previously (20, 21); (grade 1-only larynx seen; grade 2-larynx and epiglottis posterior surface seen; grade 3-larynx and epiglottis tip of anterior surface seen, <50%visual obstruction of epiglottis to larynx; grade 4-epiglottis down folded and its anterior surface seen, >50%visual obstruction of epiglottis to larynx; and grade 5-epiglottis down folded and larynx cannot be seen directly). The images will be taken in the neutral position and in mid and extreme laterally rotated neck positions.
Measured: Intraoperative from 1 minute after insertion of the device to 60 minutes after insertion of the device.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start1 Nov 2021
- Primary completion1 Oct 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway Complication of AnesthesiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Saad Abdel-Ghaffar, Assiut University
- Investigators
- Hala S Abdel-Ghaffar, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106478
- Sponsor's protocol ID
- 17101416
- Acronym
- AuraGainLMA
- Status last verified
- Jan 2024
- First submitted
- 9 Oct 2021
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Pediatric® AuraGain in Supine, Moderate Lateral, and Extreme Lateral Positions in Terms of Clinical Performance and Fiber Optic Glottic
- ClinicalTrials.gov ID
- NCT05106478
- Acronym / sponsor ID
- AuraGainLMA / 17101416
- Conditions
- Airway Complication of Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 3 Nov 2021 (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.
To compare the clinical performance of AuraGain including insertion time and success rate at first attempt, fiberoptic bronchoscopic view, oropharyngeal leak pressure, the degree of ease of gastric tube insertion, and peri-operative adverse effects in young children in supine, moderate lateral and extreme lateral position.
Detailed description
Ambu® AuraGain, a relatively novel supraglottic airway device, has been introduced recently. AuraGain has an inflatable cuff and a curved body. In addition, because the airway tube of AuraGain is wide, it can be used as a conduit for tracheal intubation. However, only a limited number of studies have been conducted on the performance of AuraGain in pediatric patients.
Changes in the position of the head and neck alter the shape of the pharynx leading to changes in the oropharyngeal leak pressure and the quality of ventilation through the LMA in both the adult and pediatric population. Having a large occiput and a relatively cephalically placed glottis, the ventilation in children is more compromised due to poor alignment of the pharyngeal-laryngeal axes during flexion of the head and neck. The hanging epiglottis covers the laryngeal inlet during flexion and the cuff of the LMA compresses the narrow laryngeal inlet both decreasing the delivered tidal volume. Different changes occur during extension and lateral rotation
Although the clinical performance of the AuraGain would be expected to be high, or at least non-inferior, to that of the widely used currently available SGAs, clinical trials are required to verify its performance in head and neck positions other than the neutral position (i.e flexion, extension and lateral rotation).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate lateral Group | – | Device: AuraGainPatients will be anesthetized using ® AuraGain airway that will be inserted lubricated with partially deflated cuff. After insertion, the cuff will be inflated with the recommended volume of air and operation will undergo while patient's neck in moderate lateral position. |
| Extreme lateral Group | – | Device: AuraGainPatients will be anesthetized using ® AuraGain airway that will be inserted lubricated with partially deflated cuff. After insertion, the cuff will be inflated with the recommended volume of air and operation will undergo while patient's neck in extreme lateral position. |
Who may qualify
- Ages
- 2 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- - children scheduled for elective outpatient surgery in which airway management with a® AuraGain would be appropriate.
Key inclusion criteria (5 listed)
- Weight: 15-30 kg.
- Age: 2-9 years.
- Sex: both males and females.
- ASA physical status: 1-3.
- Operation: elective outpatient surgery in which airway management with a® AuraGain would be appropriate.
Key exclusion criteria (4 listed)
- Active respiratory illness (cough, fever, rhinorrhea) on the day of anesthesia,
- Potentially difficult airway.
- Patients with history of neck, respiratory, or digestive tract pathology.
- Patients with gastroesophageal reflux, gastrointestinal stenosis, or stricture.
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 |
|---|---|---|
| AuraGainAmbu® AuraGain, a relatively novel supraglottic airway device, has been introduced recently. AuraGain has an inflatable cuff and a curved body. | Device | Extreme lateral Group, Moderate lateral Group |
Primary outcome
Oropharyngeal leak pressure
Time frame: Intraoperative from 1 minute after insertion of the device as a baseline to 60 minutes after insertion of the device
Airway leak pressure will be determined by closing the adjustable expiratory pressure-limiting (APL) valve and setting the fresh gas flow rate to 3 L/min. The airway pressure at which an audible leak in the mouth is heard is recorded as the "leak Pressure".
2 secondary outcomes
Ventilation score (grade 0, 1, 2 or 3),
Time frame: Intraoperative from 1 minute after insertion of the device as baseline to 60 minutes after insertion of the device
Fiberoptic glottic view Score
Time frame: Intraoperative from 1 minute after insertion of the device to 60 minutes after insertion of the device.
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 17 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Airway Complication of Anesthesia
Not yet recruitingPhase 3
Effect of Nebulized Lignocaine on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Patients Undergoing Tonsillectomy
Emergence Agitation, Emergence Delirium
Not yet recruiting
Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
Postoperative Pulmonary Complications
RecruitingObservational study
Comparison of Acute Airway/Respiratory Complications and Intervention Requirements in Extubations Performed During On-Hours Versus Off-Hours
Extubation Failures, Extubation
Not yet recruitingObservational study
Effect of Night Shift Versus Daytime Duty on Tracheal Intubation Complications and Duration in Surgical Patients
Airway Management, Tracheal Intubation
Recruiting
Effect of Endotracheal Tube Cuff Pressure Management on Postoperative Sore Throat in Pediatric Laparoscopic Appendectomy
Appendicitis Acute, Postoperative Sore Throat, Cough, Hoarseness
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.
Hala S Abdel-Ghaffar, MD principal investigator
Assiut University
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 Airway Complication of Anesthesia, run by Assiut 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 5 inclusion and 4 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 17 Jan 2024. 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?
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?
Oropharyngeal leak pressure (time frame: Intraoperative from 1 minute after insertion of the device as a baseline to 60 minutes after insertion of the device). 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 17 Jan 2024.