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Completed

NCT Number: NCT02478983

A Randomized Comparison of LMA (Laryngeal Mask Airway) 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.

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Key information

Conditions

Laryngeal Mask Airway

Age range

2 month–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, University of Malaya

Kuala Lumpur, 50603, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

LMA Supreme

Device

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 proseal

Device

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.

Primary outcomes

  1. Oropharyngeal leak pressure

    Time frame: intraoperative

    The measurement of oropharyngeal airway pressure when airway leak occurred

Secondary outcomes

  1. Insertion success rate

    Time frame: intraoperative

    The number of attempts for successful placement of the supraglottic airway is recorded.

  2. Fibreoptic glottis view

    Time frame: intraoperative

    Fibreoptic glottis view will be recorded according to a grading system

  3. Intraoperative complications

    Time frame: intraoperative

    Complications such as loss of airway patency, desaturation, regurgitation of gastric contents, laryngospasm, bronchospasm and airway trauma will be recorded

  4. Time to insertion

    Time frame: intraoperative

    Time from picking up the supraglottic airway device to the first detection of capnography square wave

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

A Randomized Comparison of LMA Supreme and LMA Proseal in Infants Below 10kg

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 23, 2015
Registry last updated
Jan 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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