The Safety and Efficacy of Supraglottic Airway Use in Children

NCT02202174 | Unknown

• 1 other identifier: 2014-15832
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

This purpose of this study is to determine the effectiveness, risk factors, and complications associated with use of supraglottic airway devices for primary airway maintenance during routine anesthesia in children.

Conditions

Supraglottic Airway Use in Children

Keywords

supraglottic airway; children; safety; efficacy

Outcome Measures

Primary Outcomes (1)

• Supraglottic Airway Device Failure

  Occurrence and reason for supraglottic airway device failure (ie inadequate ventilation, laryngospasm, bronchospasm, etc) will be recorded in addition to conversion to tracheal intubation

  participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

Secondary Outcomes (6)

• Ease of Placement of Supraglottic Airway Device

  participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

• Multiple Attempts to Place Supraglottic Airway Device

  participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

• Airway Maneuvers/interventions

  participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

• Occurrence of Inadequate Ventilation

  participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

• Intraoperative Complications

  participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

Study Arms (1)

Supraglottic Airway Device

Patients will receive a supraglottic airway device as a primary means of ventilation. The following devices may be used: LMA Unique, LMA ProSeal, LMA Supreme, LMA Flexible, Ambu Aura-I, Ambu Aura Once, Air-Q, I-Gel, or other supraglottic airway device. Choice of the device will be clinician dependent and based on the patients body weight per manufacturer guidelines

Device: Supraglottic Airway Device

Interventions

Supraglottic Airway Device DEVICE

Also known as: LMA Unique, LMA ProSeal, LMA Supreme, LMA Flexible, Ambu Aura-i, Ambu Aura Once, Air-Q, I-Gel

Supraglottic Airway Device

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients undergoing anesthesia with use of a supraglottic airway device as primary means of oxygenation and ventilation.

You may qualify if:

• Children undergoing anesthesia with use of a supraglottic airway device as a primary means of oxygenation \& ventilation

You may not qualify if:

• N/A

Sponsors & Collaborators

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

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (6)

• Jagannathan N, Sequera-Ramos L, Sohn L, Wallis B, Shertzer A, Schaldenbrand K. Elective use of supraglottic airway devices for primary airway management in children with difficult airways. Br J Anaesth. 2014 Apr;112(4):742-8. doi: 10.1093/bja/aet411. Epub 2013 Dec 8.

  PMID: 24322570 BACKGROUND

• Asai T. Is it safe to use supraglottic airway in children with difficult airways? Br J Anaesth. 2014 Apr;112(4):620-2. doi: 10.1093/bja/aeu005. Epub 2014 Feb 20. No abstract available.

  PMID: 24561643 BACKGROUND

• Lopez-Gil M, Brimacombe J, Alvarez M. Safety and efficacy of the laryngeal mask airway. A prospective survey of 1400 children. Anaesthesia. 1996 Oct;51(10):969-72. doi: 10.1111/j.1365-2044.1996.tb14968.x.

  PMID: 8984875 BACKGROUND

• Bordet F, Allaouchiche B, Lansiaux S, Combet S, Pouyau A, Taylor P, Bonnard C, Chassard D. Risk factors for airway complications during general anaesthesia in paediatric patients. Paediatr Anaesth. 2002 Nov;12(9):762-9. doi: 10.1046/j.1460-9592.2002.00987.x.

  PMID: 12519134 BACKGROUND

• Lalwani K, Richins S, Aliason I, Milczuk H, Fu R. The laryngeal mask airway for pediatric adenotonsillectomy: predictors of failure and complications. Int J Pediatr Otorhinolaryngol. 2013 Jan;77(1):25-8. doi: 10.1016/j.ijporl.2012.09.021. Epub 2012 Oct 11.

  PMID: 23063385 BACKGROUND

• Mathis MR, Haydar B, Taylor EL, Morris M, Malviya SV, Christensen RE, Ramachandran SK, Kheterpal S. Failure of the Laryngeal Mask Airway Unique and Classic in the pediatric surgical patient: a study of clinical predictors and outcomes. Anesthesiology. 2013 Dec;119(6):1284-95. doi: 10.1097/ALN.0000000000000015.

  PMID: 24126262 BACKGROUND

Study Officials

• Narasimhan Jagannathan, MD

  Ann & Robert H. Lurie Children's Hospital of Chicago / Stanley Manne Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Narasimhan Jagannathan, MD

CONTACT

3122275170; njagannathan@luriechildrens.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator; MD

Study Record Dates

• First Submitted: July 25, 2014
• First Posted: July 28, 2014
• Study Start: June 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: July 29, 2015

Record last verified: 2015-07

Locations

US (1)