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- Sperimentazione clinica NCT02202174
The Safety and Efficacy of Supraglottic Airway Use in Children
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This study aims to understand the efficacy of supraglottic airway (SGA) use in children in a tertiary care Children's Hospital.
Observational data regarding the type of SGA, experience level of practitioner, placement technique, number of placement attempts or placement failure, device failure, and cause of any related peri-operative complications will be prospectively collected.
The data collected in this study will allow the investigators to assess the overall safety and efficacy of SGA use in various medical and surgical procedures performed under general anesthesia in children.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Contatto studio
- Nome: Narasimhan Jagannathan, MD
- Numero di telefono: 3122275170
- Email: njagannathan@luriechildrens.org
Luoghi di studio
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Illinois
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Chicago, Illinois, Stati Uniti, 60611
- Reclutamento
- Ann & Robert H. Lurie Children's Hospital of Chicago
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Contatto:
- Narasimhan Jagannathan, MD
- Email: simjag2000@yahoo.com
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Investigatore principale:
- Narasimhan Jagannathan, MD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Children undergoing anesthesia with use of a supraglottic airway device as a primary means of oxygenation & ventilation
Exclusion Criteria:
- N/A
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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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
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Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Supraglottic Airway Device Failure
Lasso di tempo: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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Occurrence and reason for supraglottic airway device failure (ie inadequate ventilation, laryngospasm, bronchospasm, etc) will be recorded in addition to conversion to tracheal intubation
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participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Ease of Placement of Supraglottic Airway Device
Lasso di tempo: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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Ease of placement of supraglottic airway device ranging from 1 (easy) to 4 (difficult)
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participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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Multiple Attempts to Place Supraglottic Airway Device
Lasso di tempo: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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change in device, placement method, and provider will be recorded
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participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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Airway Maneuvers/interventions
Lasso di tempo: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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the number and type of airway maneuvers performed after device placement and during maintenance will be recorded
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participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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Occurrence of Inadequate Ventilation
Lasso di tempo: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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cause and solution for inadequate ventilation will be recorded
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participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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Intraoperative Complications
Lasso di tempo: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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Time period of complication (ie during device placement, maintenance, or removal) and cause of complication (ie.
dental injury, light anesthesia, regurgitation, laryngospasm, bronchospasm, aspiration, etc.) will be recorded
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participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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Postoperative Complications
Lasso di tempo: participants will be followed for the duration of anesthesia and 24 hours postoperatively
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Complications noted postoperatively relating to reflex activation of the airway, sore throat, or hoarseness
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participants will be followed for the duration of anesthesia and 24 hours postoperatively
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Narasimhan Jagannathan, MD, Ann & Robert H. Lurie Children's Hospital of Chicago / Stanley Manne Research Institute
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 2014-15832
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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