Laryngeal MasksNCT03139292
Comparative Evaluation of Ambu AuraGain Laryngeal Mask and Proseal Laryngeal Mask Airway
A study testing ProSeal Laryngeal Mask Airway and AmbuAuraGain Laryngeal Mask Airway in people with Laryngeal Masks, run by Tata Main Hospital at 1 site in India.
Trial summary
Comparison of two different supraglottic airway devices i.e., the ProSeal Laryngeal Mask Airway (PLMA) and Ambu AuraGain, a third generation laryngeal mask Airway. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Laryngeal Masks
- What is being tested?
- ProSeal Laryngeal Mask Airway and AmbuAuraGain Laryngeal Mask Airway
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteIndia
- Study dates
- May 2016to Oct 2019
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) Physical Status I \& II
- Patients undergoing limb or breast surgery
- Patients undergoing elective surgery under general anesthesia and spontaneous ventilation.
- Patients with expected duration of surgery of less than 2 hours.
Who cannot join
- Patients with known or predicted difficult airway or Mallampati Grade (MPG) III or IV
- Patients with mouth opening of less than 2.5 cm or cervical spine disease
- Patients with H/o upper respiratory tract infection in the previous 10 days.
- Patients with increased risk of regurgitation and aspiration (non-fasting patients, gastroesophageal reflux disease etc.)
- Patients with a body mass index (BMI) > 30 kg/m2
- Patients with past history of radiotherapy involving the hypopharynx/neck area 7Patients with expected duration of surgery of more than 2 hours.
- 8.Surgery to be performed to the head, neck or thorax, abdomen or in the lateral or prone positions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Ambu AuraGain Laryngeal Mask and Proseal Laryngeal Mask Airway in Spontaneously Breathing Patients Undergoing Elective Surgery Under General Anaesthesia
Comparison of two different supraglottic airway devices i.e., the ProSeal Laryngeal Mask Airway (PLMA) and Ambu AuraGain, a third generation laryngeal mask Airway.
Read the detailed description
The study aims to compare the two devices with respect to:
Time taken for insertion. Insertion attempts or failed attempt. Oropharyngeal leak pressure Air leak Time taken to pass an orogastric tube Attempts to pass an orogastric tube or failed attempt. Haemodynamic variation Incidence of adverse events like failed insertion, aspiration-regurgitation, hypoxia (SpO2< 90%), bronchospasm, airway obstruction, gastric insufflation, coughing, gagging, retching, hiccup, coughing during removal, blood staining of the airway device and trauma to tongue, lip, teeth, or gums.
- Conditions
- Laryngeal Masks
- Being tested
- ProSeal Laryngeal Mask Airway, AmbuAuraGain Laryngeal Mask Airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProSeal Laryngeal Mask AirwayDevice
ProSeal Laryngeal Mask Airway was used as the supraglottic device
AmbuAuraGain Laryngeal Mask AirwayDevice
AmbuAuraGain Laryngeal Mask Airway was used as the supraglottic device
| Study group | Role | What they receive |
|---|---|---|
| ProSeal Laryngeal Mask Airway | Experimental | Intravenous (0.02mg/kg Midazolam and 2 microgram/kg Fentanyl) and oxygen via a face mask will be administered. Two minutes later, general anesthesia will be induced using 2 mg/kg intravenous Propofol mixed with 25 mg Lidocaine Injected over 30 seconds, Mask ventilation commence and continue for at least 30 seconds until conditions are suitable for PLMA insertion Receives: Device: ProSeal Laryngeal Mask Airway |
| AmbuAuraGain Laryngeal Mask Airway | Experimental | Intravenous (0.02mg/kg Midazolam and 2 microgram/kg Fentanyl) and oxygen via a face mask will be administered. Two minutes later, general anesthesia will be induced using 2 mg/kg intravenous Propofol mixed with 25 mg Lidocaine Injected over 30 seconds, Mask ventilation commence and continue for at least 30 seconds until conditions are suitable for AmbuAuraGain Laryngeal Mask Airway insertion Receives: Device: AmbuAuraGain Laryngeal Mask Airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate for the first attempt at insertion
A failed insertion attempt is defined as when removal of the device needed from the mouth.
Measured: 5 minutes
Secondary outcomes (4)
Time taken for insertion
Time taken for insertion from picking up the LMA till confirmation of effective ventilation
Measured: 5 minutes
The number of insertion attempts
The number of insertion attempts or failed attempt to achieve effective ventilation. A failed insertion attempt is defined as when removal of the device needed from the mouth. Three attempts allowed before insertion will be considered a failure.
Measured: 5 minutes
Intracuff and the oropharyngeal leak pressures after ensuring effective placement.
Intracuff and the oropharyngeal leak pressures after ensuring effective placement. These pressures will be determined by closing the expiratory valve of the circle system at a fresh gas flow of 3 l/min, note the airway pressure (maximum allowed: 40 cm H2O) at which equilibrium was reached.
Measured: 5 minutes
The time taken for orogastric tube placement
The time taken for correct placement will be recorded, from Picking up the orogastric tube till confirmation of its placement.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study startMay 2016
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal MasksStudies 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
- Model description
- Prospective randomized single blinded parallel group controlled study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tata Main Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Deb Sanjay Nag, Tata Main Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139292
- Sponsor's protocol ID
- 201-26104-152-206580
- Status last verified
- Dec 2019
- First submitted
- 1 May 2017
- Last updated
- 30 Dec 2019
- 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 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Ambu AuraGain Laryngeal Mask and Proseal Laryngeal Mask Airway in Spontaneously Breathing Patients Undergoing Elective Surgery Under General Anaesthesia
- ClinicalTrials.gov ID
- NCT03139292
- Acronym / sponsor ID
- 201-26104-152-206580
- Conditions
- Laryngeal Masks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Tata Main HospitalUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 3 May 2017 (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.
Comparison of two different supraglottic airway devices i.e., the ProSeal Laryngeal Mask Airway (PLMA) and Ambu AuraGain, a third generation laryngeal mask Airway.
Detailed description
The study aims to compare the two devices with respect to:
Time taken for insertion. Insertion attempts or failed attempt. Oropharyngeal leak pressure Air leak Time taken to pass an orogastric tube Attempts to pass an orogastric tube or failed attempt. Haemodynamic variation Incidence of adverse events like failed insertion, aspiration-regurgitation, hypoxia (SpO2< 90%), bronchospasm, airway obstruction, gastric insufflation, coughing, gagging, retching, hiccup, coughing during removal, blood staining of the airway device and trauma to tongue, lip, teeth, or gums.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized single blinded parallel group controlled study
| Arm | Type | Receives |
|---|---|---|
| ProSeal Laryngeal Mask Airway | Experimental | Device: ProSeal Laryngeal Mask AirwayIntravenous (0.02mg/kg Midazolam and 2 microgram/kg Fentanyl) and oxygen via a face mask will be administered. Two minutes later, general anesthesia will be induced using 2 mg/kg intravenous Propofol mixed with 25 mg Lidocaine Injected over 30 seconds, Mask ventilation commence and continue for at least 30 seconds until conditions are suitable for PLMA insertion |
| AmbuAuraGain Laryngeal Mask Airway | Experimental | Device: AmbuAuraGain Laryngeal Mask AirwayIntravenous (0.02mg/kg Midazolam and 2 microgram/kg Fentanyl) and oxygen via a face mask will be administered. Two minutes later, general anesthesia will be induced using 2 mg/kg intravenous Propofol mixed with 25 mg Lidocaine Injected over 30 seconds, Mask ventilation commence and continue for at least 30 seconds until conditions are suitable for AmbuAuraGain Laryngeal Mask Airway insertion |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) Physical Status I \& II
- Patients undergoing limb or breast surgery
- Patients undergoing elective surgery under general anesthesia and spontaneous ventilation.
- Patients with expected duration of surgery of less than 2 hours.
Key exclusion criteria (7 listed)
- Patients with known or predicted difficult airway or Mallampati Grade (MPG) III or IV
- Patients with mouth opening of less than 2.5 cm or cervical spine disease
- Patients with H/o upper respiratory tract infection in the previous 10 days.
- Patients with increased risk of regurgitation and aspiration (non-fasting patients, gastroesophageal reflux disease etc.)
- Patients with a body mass index (BMI) > 30 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 |
|---|---|---|
| ProSeal Laryngeal Mask AirwayProSeal Laryngeal Mask Airway was used as the supraglottic device | Device | ProSeal Laryngeal Mask Airway |
| AmbuAuraGain Laryngeal Mask AirwayAmbuAuraGain Laryngeal Mask Airway was used as the supraglottic device | Device | AmbuAuraGain Laryngeal Mask Airway |
Primary outcome
Success rate for the first attempt at insertion
Time frame: 5 minutes
A failed insertion attempt is defined as when removal of the device needed from the mouth.
4 secondary outcomes
Time taken for insertion
Time frame: 5 minutes
The number of insertion attempts
Time frame: 5 minutes
Intracuff and the oropharyngeal leak pressures after ensuring effective placement.
Time frame: 5 minutes
The time taken for orogastric tube placement
Time frame: 5 minutes
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 30 Dec 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProSeal Laryngeal Mask Airway and AmbuAuraGain Laryngeal Mask Airway in people with Laryngeal Masks, run by Tata Main Hospital at 1 site in India.
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 7 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 30 Dec 2019. 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 India. 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?
Success rate for the first attempt at insertion (time frame: 5 minutes). 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 30 Dec 2019.