Laryngeal Masks in Children Clinical Trial
Official title:
A Randomized Trial Comparing the Laryngeal Mask Airway-SupremeTM With the i-gelTM in Children
The aim of this randomized prospective study is to compare two single-use laryngeal mask airways with a provision of a gastric drain tube allowing for evacuation of gastric contents, the i-gel and the LMA Supreme, in pediatric patients undergoing positive pressure ventilation. The investigators hypothesize that airway leak pressures with the i-gel will not be significantly different clinically (higher) when compared with the LMA Supreme.
| Status | Completed |
| Enrollment | 170 |
| Est. completion date | September 2012 |
| Est. primary completion date | September 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 3 Months to 11 Years |
| Eligibility |
Inclusion Criteria: - Children undergoing general anesthesia using a supraglottic airway device - weight 5-50 kg - age 3 months-11 years Exclusion Criteria: - ASA class IV, V Emergency procedures - active respiratory infection - known history of difficult mask ventilation - a diagnosis of a congenital syndrome associated with difficult airway management - airway abnormalities (e.g., laryngomalacia, subglottic stenosis) - active gastrointestinal reflux - coagulopathy - clinically significant pulmonary disease(s) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)
| Country | Name | City | State |
|---|---|---|---|
| United States | Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| Ann & Robert H Lurie Children's Hospital of Chicago |
United States,
Beringer RM, Kelly F, Cook TM, Nolan J, Hardy R, Simpson T, White MC. A cohort evaluation of the paediatric i-gel(™) airway during anaesthesia in 120 children. Anaesthesia. 2011 Dec;66(12):1121-6. doi: 10.1111/j.1365-2044.2011.06884.x. Epub 2011 Sep 1. — View Citation
Goyal R, Shukla RN, Kumar G. Comparison of size 2 i-gel supraglottic airway with LMA-ProSeal™ and LMA-Classic™ in spontaneously breathing children undergoing elective surgery. Paediatr Anaesth. 2012 Apr;22(4):355-9. doi: 10.1111/j.1460-9592.2011.03757.x. Epub 2011 Dec 8. — View Citation
Jagannathan N, Sohn LE, Chang E, Sawardekar A. A cohort evaluation of the laryngeal mask airway-Supreme™ in children. Paediatr Anaesth. 2012 Aug;22(8):759-64. doi: 10.1111/j.1460-9592.2012.03832.x. Epub 2012 Mar 15. — View Citation
Jagannathan N, Sohn LE, Sawardekar A, Chang E, Langen KE, Anderson K. A randomised trial comparing the laryngeal mask airway Supreme™ with the laryngeal mask airway Unique™ in children. Anaesthesia. 2012 Feb;67(2):139-44. doi: 10.1111/j.1365-2044.2011.06960.x. Epub 2011 Nov 9. — View Citation
Jagannathan N, Sohn LE, Sawardekar A, Gordon J, Langen KE, Anderson K. A randomised comparison of the LMA SupremeTM and LMAProSealTM in children. Anaesthesia. 2012 Jun;67(6):632-9. doi: 10.1111/j.1365-2044.2012.07088.x. Epub 2012 Mar 15. — View Citation
Lee JR, Kim MS, Kim JT, Byon HJ, Park YH, Kim HS, Kim CS. A randomised trial comparing the i-gel (TM) with the LMA Classic (TM) in children. Anaesthesia. 2012 Jun;67(6):606-11. doi: 10.1111/j.1365-2044.2012.07072.x. Epub 2012 Feb 21. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | No |
| Secondary | Time to secure the airway | From picking up the airway device to bilateral chest expansion and presence of ETCO2 | Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | No |
| Secondary | Number of attempts to place the device | Number of attempts needed for successful placement will be recorded (maximum of 3 attempts will be considered as a failure) | Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | No |
| Secondary | Fiberoptic grade of laryngeal view | The laryngeal alignment through the devices will be graded using an established scoring system | Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | No |
| Secondary | Gastric insufflation | The presence of gastric insufflations will be assessed during leak pressure testing by using epigastric auscultation | Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | No |
| Secondary | Ease of gastric tube placement | The ease of gastric placement will be timed and assessed using a subjective scale | Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | No |
| Secondary | Feasibility of positive pressure ventilation | Peak inspiratory pressure and tidal volumes will be recorded. Maximum peak inspiratory pressure will be the airway leak pressure was determined for each patient | Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | No |
| Secondary | Quality of the airway | The quality of hands free anesthesia will be assessed during maintenance of anesthesia using a previously described scale | Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | No |
| Secondary | Incidence of device repositioning and/or replacement | Intra-operative device repositioning or replacement of the device due to excessive air leak or airway obstruction, as evidenced by an obstructive pattern on the continuous end-tidal carbon dioxide monitor that leads to a decrease in oxygen saturation by pulse oximetry to less than 90%. | Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours | No |
| Secondary | Oropharyngolaryngeal morbidity at discharge | Assessed by the subject's response or parents subjective assesment to standardized questions regarding oropharyngeal complaints such as sore throat, jaw pain, neck discomfort. | Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours | Yes |
| Secondary | Oropharyngolaryngeal morbidity at 24 hours post-operatively | Assessed by the subject's response or parents subjective assesment to standardized questions regarding oropharyngeal complaints such as sore throat, jaw pain, neck discomfort. | Measured at 24 hours after device placement/study initiation | Yes |