Laryngeal Mask AirwayNCT02478983
A Randomized Comparison of LMA (Laryngeal Mask Airway) Supreme and LMA Proseal in Infants Below 10kg
A study testing LMA Supreme and LMA Proseal in people with Laryngeal Mask Airway, run by University of Malaya at 1 site in Malaysia.
Trial summary
The investigators conduct this study to evaluate the clinical efficacy of size 1 and 1.5 supreme LMA compared to proseal LMA for infants weighing <10kg. Read more about this study
- Who is it for?
- Ages 2 months to 2 years
- Conditions the study is for
- Laryngeal Mask Airway
- What is being tested?
- LMA Supreme and LMA Proseal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMalaysia
- Study dates
- Jun 2014to May 2016
- 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 2 months to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Weight of < 10kg
- ASA (American Society of Anesthesiologists) I-II
- Infants undergoing elective surgery under general anaesthesia using supraglottic airway device.
- Informed consent obtained from parents.
Who cannot join
- ASA III-IV and emergency surgery
- Neonates and ex-premature babies with post conceptual age <55 weeks.
- Infants with history of difficult airway.
- Infants with features of difficult intubation.
- Active upper respiratory tract infection
- Infants with pulmonary disease
- Infants with history of gastroesophageal reflux disease
- Infants with risks of regurgitation and aspiration.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Faculty of Medicine, University of Malaya
Kuala Lumpur, Kuala Lumpur, 50603
About this study
Official title: A Randomized Comparison of LMA Supreme and LMA Proseal in Infants Below 10kg
The investigators conduct this study to evaluate the clinical efficacy of size 1 and 1.5 supreme LMA compared to proseal LMA for infants weighing <10kg.
Read the detailed description
This is a randomized prospective study to compare the clinical efficacy and safety for size 1 and 1.5 LMA supreme and LMA Proseal. The airway leak pressure of these 2 devices will be compared and other parameters such as time to insertion, insertion success rate, fibreoptic glottic view and intraoperative complications will be recorded.
- Conditions
- Laryngeal Mask Airway
- Being tested
- LMA Supreme, LMA Proseal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMA SupremeDevice
The device will be inserted according to manufacturer's guideline. Time of insertion will be recorded. The oropharyngeal airway leak pressure will be measured when the device successfully inserted. The time taken to insert the LMA is recorded and the insertion success rate is documented. The larynx will be visualized with fibreoptic bronchoscope inserted through the LMA. Intraoperative complications will be recorded.
LMA ProsealDevice
The device will be inserted according to manufacturer's guideline. Time of insertion will be recorded. The oropharyngeal airway leak pressure will be measured when the device successfully inserted. The time taken to insert the LMA is recorded and the insertion success rate is documented. The larynx will be visualized with fibreoptic bronchoscope inserted through the LMA. Intraoperative complications will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| LMA Supreme | Experimental | 1 arm will receive LMA supreme for airway management Receives: Device: LMA Supreme |
| LMA Proseal | Active comparator | 1 arm will receive LMA Proseal for airway management Receives: Device: LMA Proseal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal leak pressure
The measurement of oropharyngeal airway pressure when airway leak occurred
Measured: intraoperative
Secondary outcomes (4)
Insertion success rate
The number of attempts for successful placement of the supraglottic airway is recorded.
Measured: intraoperative
Fibreoptic glottis view
Fibreoptic glottis view will be recorded according to a grading system
Measured: intraoperative
Intraoperative complications
Complications such as loss of airway patency, desaturation, regurgitation of gastric contents, laryngospasm, bronchospasm and airway trauma will be recorded
Measured: intraoperative
Time to insertion
Time from picking up the supraglottic airway device to the first detection of capnography square wave
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startJun 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal Mask AirwayStudies of the same condition, open and under way.
- More trials run by University of MalayaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chaw Sook Hui, University of Malaya
- Investigators
- Sook Hui Chaw, M.Med, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478983
- Sponsor's protocol ID
- 995.7
- Status last verified
- Jan 2022
- First submitted
- 7 Jun 2015
- Last updated
- 28 Jan 2022
- 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 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of LMA Supreme and LMA Proseal in Infants Below 10kg
- ClinicalTrials.gov ID
- NCT02478983
- Acronym / sponsor ID
- 995.7
- Conditions
- Laryngeal Mask Airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 23 Jun 2015 (estimated)
- 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.
The investigators conduct this study to evaluate the clinical efficacy of size 1 and 1.5 supreme LMA compared to proseal LMA for infants weighing <10kg.
Detailed description
This is a randomized prospective study to compare the clinical efficacy and safety for size 1 and 1.5 LMA supreme and LMA Proseal. The airway leak pressure of these 2 devices will be compared and other parameters such as time to insertion, insertion success rate, fibreoptic glottic view and intraoperative complications will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LMA Supreme | Experimental | Device: LMA Supreme1 arm will receive LMA supreme for airway management |
| LMA Proseal | Active comparator | Device: LMA Proseal1 arm will receive LMA Proseal for airway management |
Who may qualify
- Ages
- 2 months to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Weight of < 10kg
- ASA (American Society of Anesthesiologists) I-II
- Infants undergoing elective surgery under general anaesthesia using supraglottic airway device.
- Informed consent obtained from parents.
Key exclusion criteria (8 listed)
- ASA III-IV and emergency surgery
- Neonates and ex-premature babies with post conceptual age <55 weeks.
- Infants with history of difficult airway.
- Infants with features of difficult intubation.
- Active upper respiratory tract infection
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 |
|---|---|---|
| LMA SupremeThe device will be inserted according to manufacturer's guideline. Time of insertion will be recorded. The oropharyngeal airway leak pressure will be measured when the device successfully inserted. The time taken to insert the LMA is recorded and the insertion success rate is documented. The larynx will be visualized with fibreoptic bronchoscope inserted through the LMA. Intraoperative complications will be recorded. | Device | LMA Supreme |
| LMA ProsealThe device will be inserted according to manufacturer's guideline. Time of insertion will be recorded. The oropharyngeal airway leak pressure will be measured when the device successfully inserted. The time taken to insert the LMA is recorded and the insertion success rate is documented. The larynx will be visualized with fibreoptic bronchoscope inserted through the LMA. Intraoperative complications will be recorded. | Device | LMA Proseal |
Primary outcome
Oropharyngeal leak pressure
Time frame: intraoperative
The measurement of oropharyngeal airway pressure when airway leak occurred
4 secondary outcomes
Insertion success rate
Time frame: intraoperative
Fibreoptic glottis view
Time frame: intraoperative
Intraoperative complications
Time frame: intraoperative
Time to insertion
Time frame: intraoperative
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 28 Jan 2022.
- 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.
Sook Hui Chaw, M.Med principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LMA Supreme and LMA Proseal in people with Laryngeal Mask Airway, run by University of Malaya at 1 site in Malaysia.
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 8 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 28 Jan 2022. 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 Malaysia. 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). 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 28 Jan 2022.