SurgeryNCT03251105
Supreme Versus Proseal Laryngeal Mask Airways in Infants
A study testing supraglottic airway intubation in people with Surgery and Infant Conditions, run by Sisli Hamidiye Etfal Training and Research Hospital.
Trial summary
In this study, the Supreme and ProSeal LMAs in infants were compared by measuring their performance characteristics, including insertion features, ventilation parameters, induced changes in hemodynamics and rates of postoperative complications. Read more about this study
- Who is it for?
- Ages Up to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Surgery, Infant Conditions, Anesthesia
- What is being tested?
- supraglottic airway intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 27 Apr 2016to 31 Jan 2017
- 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 Up to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- scheduled for elective, minor (<1 hour duration), lower abdominal surgery, including unilateral herniorrhaphy and unilateral orchidopexy
Who cannot join
- premature birth, potentially difficult airway, clinically significant upper respiratory tract infection and risk of aspiration, such as gastro-oesophageal reflux disease
About this study
Official title: Comparison of the Supreme™ And Proseal™ Laryngeal Mask Airways in Infants: A Prospective Randomised Clinical Study
In this study, the Supreme and ProSeal LMAs in infants were compared by measuring their performance characteristics, including insertion features, ventilation parameters, induced changes in hemodynamics and rates of postoperative complications.
Read the detailed description
Both the Supreme™ and ProSeal™ laryngeal mask airways (LMAs) are widely used for paediatric anaesthesia; however, LMA use in infants is limited, as many anaesthesiologists prefer to use tracheal intubation in infants.
In this study, the Supreme and ProSeal LMAs in infants were compared by measuring their performance characteristics, including insertion features, ventilation parameters, induced changes in hemodynamics and rates of postoperative complications.
Infants of ASA physical status I who were scheduled for elective, minor, lower abdominal surgery were divided into two groups: the Supreme LMA group and the ProSeal LMA group. Heart rate (HR), oxygen saturation and end tidal carbon dioxide values were recorded both before and after LMA insertion, as well as both before and after extubation. After extubation, complications and adverse effects were noted.
Demographics and surgical data were similar between the two groups. LMA insertion times for the ProSeal group were shorter, the leakage pressure for the ProSeal group was statistically higher. The ProSeal LMA is superior to the Supreme LMA for use in infants, due to its ease of insertion, high oropharyngeal leakage pressure and fewer induced changes in hemodynamics.
- Conditions
- Surgery, Infant Conditions, Anesthesia
- Being tested
- supraglottic airway intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supraglottic airway intubationDevice
| Study group | Role | What they receive |
|---|---|---|
| ProSeal group | Active comparator | This group received the ProSeal LMA for supraglottic airway intubation and ventilation during anaesthesia. Receives: Device: supraglottic airway intubation |
| Supreme group | Active comparator | This group received the Supreme LMA for supraglottic airway intubation and ventilation during anaesthesia. Receives: Device: supraglottic airway intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
performance characteristics
insertion time in minutes
Measured: operation duration
Secondary outcomes (1)
haemodynamics
end tidal CO2 (EtCO2) in mmHg
Measured: operation duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start27 Apr 2016
- Primary completion31 Dec 2016
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies 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
- Infants, who were scheduled to undergo lower abdominal surgery and to receive anaesthesia
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Canan Tulay ISIL, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Sibel Oba, MD, Principal investigator, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251105
- Sponsor's protocol ID
- SEEAH/26.04.2016/659
- Status last verified
- Aug 2017
- First submitted
- 7 Aug 2017
- Last updated
- 16 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We can only share data as Exel or SSPS, but not with patient names.
Publications
Luce V, Harkouk H, Brasher C, Michelet D, Hilly J, Maesani M, Diallo T, Mangalsuren N, Nivoche Y, Dahmani S. Supraglottic airway devices vs tracheal intubation in children: a quantitative meta-analysis of respiratory complications. Paediatr Anaesth. 2014 Oct;24(10):1088-98. doi: 10.1111/pan.12495. Epub 2014 Jul 30.
PubMed 25074619Oba S, Turk HS, Isil CT, Erdogan H, Sayin P, Dokucu AI. Comparison of the Supreme and ProSeal laryngeal mask airways in infants: a prospective randomised clinical study. BMC Anesthesiol. 2017 Sep 5;17(1):125. doi: 10.1186/s12871-017-0418-z.
PubMed 28870163
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Supreme™ And Proseal™ Laryngeal Mask Airways in Infants: A Prospective Randomised Clinical Study
- ClinicalTrials.gov ID
- NCT03251105
- Acronym / sponsor ID
- SEEAH/26.04.2016/659
- Conditions
- Surgery, Infant Conditions, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 27 Apr 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 16 Aug 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.
In this study, the Supreme and ProSeal LMAs in infants were compared by measuring their performance characteristics, including insertion features, ventilation parameters, induced changes in hemodynamics and rates of postoperative complications.
Detailed description
Both the Supreme™ and ProSeal™ laryngeal mask airways (LMAs) are widely used for paediatric anaesthesia; however, LMA use in infants is limited, as many anaesthesiologists prefer to use tracheal intubation in infants.
In this study, the Supreme and ProSeal LMAs in infants were compared by measuring their performance characteristics, including insertion features, ventilation parameters, induced changes in hemodynamics and rates of postoperative complications.
Infants of ASA physical status I who were scheduled for elective, minor, lower abdominal surgery were divided into two groups: the Supreme LMA group and the ProSeal LMA group. Heart rate (HR), oxygen saturation and end tidal carbon dioxide values were recorded both before and after LMA insertion, as well as both before and after extubation. After extubation, complications and adverse effects were noted.
Demographics and surgical data were similar between the two groups. LMA insertion times for the ProSeal group were shorter, the leakage pressure for the ProSeal group was statistically higher. The ProSeal LMA is superior to the Supreme LMA for use in infants, due to its ease of insertion, high oropharyngeal leakage pressure and fewer induced changes in hemodynamics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Infants, who were scheduled to undergo lower abdominal surgery and to receive anaesthesia
| Arm | Type | Receives |
|---|---|---|
| ProSeal group | Active comparator | Device: supraglottic airway intubationThis group received the ProSeal LMA for supraglottic airway intubation and ventilation during anaesthesia. |
| Supreme group | Active comparator | Device: supraglottic airway intubationThis group received the Supreme LMA for supraglottic airway intubation and ventilation during anaesthesia. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- scheduled for elective, minor (<1 hour duration), lower abdominal surgery, including unilateral herniorrhaphy and unilateral orchidopexy
Key exclusion criteria (1 listed)
- premature birth, potentially difficult airway, clinically significant upper respiratory tract infection and risk of aspiration, such as gastro-oesophageal reflux disease
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 |
|---|---|---|
| supraglottic airway intubation | Device | ProSeal group, Supreme group |
Primary outcome
performance characteristics
Time frame: operation duration
insertion time in minutes
1 secondary outcome
haemodynamics
Time frame: operation duration
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 16 Aug 2017.
- Background: PubMed 25074619Luce V, Harkouk H, Brasher C, Michelet D, Hilly J, Maesani M, Diallo T, Mangalsuren N, Nivoche Y, Dahmani S. Supraglottic airway devices vs tracheal intubation in children: a quantitative meta-analysis of respiratory complications. Paediatr Anaesth. 2014 Oct;24(10):1088-98. doi: 10.1111/pan.12495. Epub 2014 Jul 30.
- Derived from this study: PubMed 28870163Oba S, Turk HS, Isil CT, Erdogan H, Sayin P, Dokucu AI. Comparison of the Supreme and ProSeal laryngeal mask airways in infants: a prospective randomised clinical study. BMC Anesthesiol. 2017 Sep 5;17(1):125. doi: 10.1186/s12871-017-0418-z.
- Individual participant dataSharing planned: No. We can only share data as Exel or SSPS, but not with patient names.
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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.
Sibel Oba, MD principal investigator
Sisli Hamidiye Etfal Training and Research Hospital
Questions about this trial
What is this clinical trial studying?
A study testing supraglottic airway intubation in people with Surgery and Infant Conditions, run by Sisli Hamidiye Etfal Training and Research Hospital.
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 1 inclusion and 1 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 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
performance characteristics (time frame: operation duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03251105, which also lists 2 linked publications.
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 16 Aug 2017.