CClinicalTrials.gg
Sign In
CompletedNCT03251105Updated Aug 16, 2017

Supreme Versus Proseal Laryngeal Mask Airways in Infants

An interventional study of supraglottic airway intubation in Surgery, Infant Conditions and Anesthesia, sponsored by Sisli Hamidiye Etfal Training and Research Hospital. Completed. Open to participants aged Up to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-16.

Sponsored by Sisli Hamidiye Etfal Training and Research Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
Up to 12 Months
Sex
All
01

Study 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 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.

02

Conditions studied

  • Surgery
  • Infant Conditions
  • Anesthesia
03

Who can participate

Ages eligible
Up to 12 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • scheduled for elective, minor (\<1 hour duration), lower abdominal surgery, including unilateral herniorrhaphy and unilateral orchidopexy

Exclusion criteria

Exclusion Criteria:

  • premature birth, potentially difficult airway, clinically significant upper respiratory tract infection and risk of aspiration, such as gastro-oesophageal reflux disease
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    ProSeal group

    This group received the ProSeal LMA for supraglottic airway intubation and ventilation during anaesthesia.

    Device: supraglottic airway intubation

  • Active comparator
    Supreme group

    This group received the Supreme LMA for supraglottic airway intubation and ventilation during anaesthesia.

    Device: supraglottic airway intubation

Interventions

  • Devicesupraglottic airway intubation
05

What researchers measure

Primary outcomes

  1. performance characteristics

    insertion time in minutes

    Time frame: operation duration

Secondary outcomes

  1. haemodynamics

    end tidal CO2 (EtCO2) in mmHg

    Time frame: operation duration

06

Study locations

No study locations are listed for this record.

07

References and documents

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 25074619 ↗
  • Oba 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 ↗

Individual participant data

Plan to share: No — We can only share data as Exel or SSPS, but not with patient names.

08

Registry details

Key details

Study ID
NCT03251105
Lead sponsor
Sisli Hamidiye Etfal Training and Research Hospital
Responsible party
Canan Tulay ISIL (Specialist, M.D., Sisli Hamidiye Etfal Training and Research Hospital) — Principal investigator
First posted
Aug 16, 2017
Start date
Apr 27, 2016
Primary completion
Dec 31, 2016
Completion
Jan 31, 2017
Last update
Aug 16, 2017

Study contacts

Sibel Oba, MD
principal investigator · Sisli Hamidiye Etfal Training and Research Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Start the discussion