Supreme Versus Proseal Laryngeal Mask Airways in Infants

NCT03251105 | Completed DMC

• 1 other identifier: SEEAH/26.04.2016/659
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Surgery; Infant Conditions; Anesthesia

Outcome Measures

Primary Outcomes (1)

• performance characteristics

  insertion time in minutes

  operation duration

Secondary Outcomes (1)

• haemodynamics

  operation duration

Study Arms (2)

ProSeal group

ACTIVE COMPARATOR

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

Device: supraglottic airway intubation

Supreme group

ACTIVE COMPARATOR

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

Device: supraglottic airway intubation

Interventions

supraglottic airway intubation DEVICE

ProSeal group; Supreme group

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Related Publications (2)

• 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.

  PMID: 25074619 BACKGROUND

• 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.

  PMID: 28870163 DERIVED

Study Officials

• Sibel Oba, MD

  Sisli Hamidiye Etfal Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist, M.D.

Model Details: Infants, who were scheduled to undergo lower abdominal surgery and to receive anaesthesia

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 16, 2017
• Study Start: April 27, 2016
• Primary Completion: December 31, 2016
• Study Completion: January 31, 2017
• Last Updated: August 16, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share