Airway Management, Children, Laryngeal Mask Airway
Conditions
Keywords
Supraglottic Airway, Laryngeal Mask Airway, Children, Complication
Brief summary
This study is designed to observe the occurrence of failure or difficulty during placement of supraglottic airway devices (SGAs) and its associated risk factors in pediatric patients. Despite wide use in pediatric practice, not much is known related to problems during SGA insertion unlike adults. The main information regarding pediatric SGA comes from either small comparative studies or retrospective studies reporting increased risk of failure. Thus the main aim of this prospective, multicentric, observational study is to determine the incidence of "difficult" or "failed" SGA placement in children and clarify the possible risk factors for difficulty.
Detailed description
Inclusion criteria * 1- 12 years old peditatric patients * ASA class I- III * Scheduled for elective surgery under general anaesthesia, in whom a SGA would be used for airway maintenance * Planned surgery under general anesthesia with SGA * Patients whose legal guardians provide informed consent Exclusion criteria * Refusal to participate in the study. * Inability of patient or parents to understand the study or consent process * Orotracheal intubation requirement * Pathology of airway, neck, respiratory tract, upper gastrointestinal tract * Increased risk of regurgitation or aspiration * Emergency surgeries * Requirement for intensive care follow-up after the surgery
Interventions
None listed
Sponsors
Alper Kilicaslan
Emre Sertaç Bingül
Nüzhet Mert Şentürk
Sibel Seçkin Pehlivan
Şengül Özmert
Özlem Sezen
Gaye Aydın
Esra Turunç
Faruk Çiçekçi
Sedat Saylan
Alkin Çolak
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* 1- 12 years old peditatric patients * ASA class I- III * Planned surgery under general anesthesia with supraglottic airway * Patients whose legal guardians provide informed consent
Exclusion criteria
* Refusal to participate in the study * Inability of patient or parents to understand the study or consent process * Orotracheal intubation requirement * Pathology of airway, neck, respiratory tract, upper gastrointestinal tract * Increased risk of regurgitation or aspiration * Emergency surgeries * Requirement for intensive care follow-up after the surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of difficulty in supraglottic airway device(SGA) placement | Immediately after the attempt of insertion and up to the end of the surgery | Difficulty in placing SGA is defined as follows: SGA insertion that requires more than one attempt,need for a change the size or type of SGA,desatutaion (SpO2\<93%), disrupted capnography,high airway pressure (\>25 cmH2O of peak pressure) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk factors for pediatric difficult SGA placement | At the beginning of anesthesia | Possible risk factors related with failure and difficulty listed as:experience of the anaesthetist , presence of history of asthma/pneumoniae,presence of craniofascial anomalies, use of neuromuscular blocking agent, type and placement technique of SGA |
| The incidence of complications related to SGA insertion | Up to 24 hours after surgery | The incidence of adverse events including laryngospasm, desaturation bronchospasm, stridor, regurgitation bucking, airway trauma and postoperative complications including difficult weaning, cough, stridor, vomiting, dysfagia, dysphonia |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORAlper Kilicaslan
Necmettin Erbakan Universty Medical Faculty
Outcome results
None listed