A Comparison of the LMA Unique and LMA Supreme in Children

NCT01409785 | Completed

• 1 other identifier: LMA unique vs LMA supreme
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to compare the LMA Unique and LMA Supreme in children having surgery. We hypothesize that the airway leak pressures with the LMA Supreme will be superior to the LMA Unique. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. The ease of placement, fiberoptic grade of laryngeal view, feasibility of use, and complications (airway related, gastric insufflation, trauma) will also be assessed.

Conditions

Children

Keywords

supraglottic airway devices in children

Outcome Measures

Primary Outcomes (1)

• Airway leak pressure

  Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached when fresh gas flow is delivered at 3L/min when the pressure limiting valve is closed completely.

  after placement of the supraglottic airway device/ Participants will be followed 24 hours postoperatively

Secondary Outcomes (8)

• Fiberoptic grade of laryngeal view

  After placement of the supraglottic device

• Adverse effects

  Participants will be followed 24 hours postoperatively

• Time to secure the airway

  after placement of the supraglottic airway device

• Number of attempts to place the device

  at the beginning of anesthesia

• Fiberoptic view through the gastric tube

  After placement of the LMA supreme

Study Arms (2)

LMA Supreme

LMA unique

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children weighing 10 to 25 kg undergoing surgical or medical procedures under anesthesia requiring a supraglottic airway device

You may qualify if:

• Children undergoing general anesthesia using a supraglottic airway device
• weight 10-25kg
• age 6 months-6 years

You may not qualify if:

• ASA class IV, V Emergency procedures
• History of a difficult airway
• Active gastrointestinal reflux
• Active upper respiratory tract infection

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Childrens Memorial Hospital

Chicago, Illinois, 60614, United States

Location

Related Publications (4)

• Verghese C, Ramaswamy B. LMA-Supreme--a new single-use LMA with gastric access: a report on its clinical efficacy. Br J Anaesth. 2008 Sep;101(3):405-10. doi: 10.1093/bja/aen174. Epub 2008 Jun 17.

  PMID: 18559351 BACKGROUND

• Timmermann A, Cremer S, Eich C, Kazmaier S, Brauer A, Graf BM, Russo SG. Prospective clinical and fiberoptic evaluation of the Supreme laryngeal mask airway. Anesthesiology. 2009 Feb;110(2):262-5. doi: 10.1097/ALN.0b013e3181942c4d.

  PMID: 19194153 BACKGROUND

• Cook TM, Gatward JJ, Handel J, Hardy R, Thompson C, Srivastava R, Clarke PA. Evaluation of the LMA Supreme in 100 non-paralysed patients. Anaesthesia. 2009 May;64(5):555-62. doi: 10.1111/j.1365-2044.2008.05824.x.

  PMID: 19413827 BACKGROUND

• White MC, Cook TM, Stoddart PA. A critique of elective pediatric supraglottic airway devices. Paediatr Anaesth. 2009 Jul;19 Suppl 1:55-65. doi: 10.1111/j.1460-9592.2009.02997.x.

  PMID: 19572845 BACKGROUND

Study Officials

• narasimhan jagannathan, MD

  childrens memorial hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 3, 2011
• First Posted: August 4, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 5, 2011

Record last verified: 2011-10

Locations

US (1)