Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06337006
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2024-03-21
Brief Title:
Laryngeal Mask Airway Failure in Pediatric Patients
Sponsor:
Samsun University
Organization:
Samsun University
Study Overview
Official Title:
Identification of Laryngeal Mask Airway Failure in Pediatric Patients With Objective Criteria a Pilot Study
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There are a significant number of studies identifying risk factors for misplacement of LMAs However despite objective data indicating that tracheal intubation is performed inappropriately such as air leaks high air pressures insufficient lung ventilation and single lung ventilation which are easily identified after tracheal intubation there are no objective data to define the misplacement of LMAs
The aim of the study was to describe unsuccessful LMA placement in pediatric patients with objective data
The aim of the study was to describe unsuccessful LMA placement in pediatric patients with objective data
Detailed Description:
Optimal use of extraglottic airways including the laryngeal mask LMA has not been fully defined using real-world data Usage patterns and the reported incidence of failure and complications in different geographic regions vary greatly In the adult population an observational study involving more than 15000 cases revealed a 11 incidence of laryngeal mask failure defined as intubation after laryngeal mask removal and 62 of patients experienced significant airway complications
Similar data are scarce in children Pediatric laryngeal mask studies report adverse event frequencies ranging from 0 to 10 These data are limited by the focus on specific surgical procedures or the small sample size resulting in simple univariate or inadequate multivariate analyses Additionally although data on adverse events are presented laryngeal mask failure requiring endotracheal intubation has been reported infrequently
There are a significant number of studies identifying risk factors for misplacement of LMAs However there are no objective data to define misplacement of LMAs
1-2 mL of lidocaine gel was applied evenly to the classic LMA Intavent Direct Maidenhead UK capsule The appropriate size of the LMA device size 15 for 5-10 kg and size 2 for 10-20 kg was selected according to the manufacturers recommendation The LMA was placed by an experienced anesthesiologist with the patients head in a neutral position with a fully deflated cuff and the patients mouth was opened then held parallel to the chest and the device was advanced along the hard palate The cuff of the device was inflated with a sufficient amount of air according to the manufacturers instructions After LMA placement patients were divided into two groups as successful Group S or unsuccessful Group non-S according to bilateral equal chest movement during inspiration square wave capnography absence of gastric insufflation epigastrium auscultation and adequate tidal volume delivery Another experienced anesthesiologist recorded the set 8 mLkg tidal volume VT expiratory tidal volume airway peak pressure SpO2 EtCO2 measurements in three respiratory cycles Airway leak ΔVT It was calculated by subtracting expiratory VT from the adjusted VT Airway leak airway peak pressure SpO2 and EtCO2 measurement were determined as possible objective predictors for LMA placement failure Postoperative airway complications It was determined and recorded as soft tissue trauma laryngospasm bronchospasm and severe cough attack
The aim of the study was to describe unsuccessful LMA placement in pediatric patients with objective data
Similar data are scarce in children Pediatric laryngeal mask studies report adverse event frequencies ranging from 0 to 10 These data are limited by the focus on specific surgical procedures or the small sample size resulting in simple univariate or inadequate multivariate analyses Additionally although data on adverse events are presented laryngeal mask failure requiring endotracheal intubation has been reported infrequently
There are a significant number of studies identifying risk factors for misplacement of LMAs However there are no objective data to define misplacement of LMAs
1-2 mL of lidocaine gel was applied evenly to the classic LMA Intavent Direct Maidenhead UK capsule The appropriate size of the LMA device size 15 for 5-10 kg and size 2 for 10-20 kg was selected according to the manufacturers recommendation The LMA was placed by an experienced anesthesiologist with the patients head in a neutral position with a fully deflated cuff and the patients mouth was opened then held parallel to the chest and the device was advanced along the hard palate The cuff of the device was inflated with a sufficient amount of air according to the manufacturers instructions After LMA placement patients were divided into two groups as successful Group S or unsuccessful Group non-S according to bilateral equal chest movement during inspiration square wave capnography absence of gastric insufflation epigastrium auscultation and adequate tidal volume delivery Another experienced anesthesiologist recorded the set 8 mLkg tidal volume VT expiratory tidal volume airway peak pressure SpO2 EtCO2 measurements in three respiratory cycles Airway leak ΔVT It was calculated by subtracting expiratory VT from the adjusted VT Airway leak airway peak pressure SpO2 and EtCO2 measurement were determined as possible objective predictors for LMA placement failure Postoperative airway complications It was determined and recorded as soft tissue trauma laryngospasm bronchospasm and severe cough attack
The aim of the study was to describe unsuccessful LMA placement in pediatric patients with objective data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None