Supreme Versus Proseal Laryngeal Mask Airways in Infants

Surgery Clinical Trial

Official title:

Comparison of the Supreme™ And Proseal™ Laryngeal Mask Airways in Infants: A Prospective Randomised Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03251105
• Other study ID #: SEEAH/26.04.2016/659
• Status: Completed
• Phase: N/A
• First received: August 7, 2017
• Last updated: August 11, 2017
• Start date: April 27, 2016
• Est. completion date: January 31, 2017

Study information

• Verified date: August 2017
• Source: Sisli Etfal Training & Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 31, 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 12 Months

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Anesthesia
• Infant Conditions
• Surgery

Intervention

Device:
• supraglottic airway intubation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Etfal Training & Research Hospital

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	performance characteristics	insertion time in minutes	operation duration
Secondary	haemodynamics	end tidal CO2 (EtCO2) in mmHg	operation duration