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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06073977
Other study ID # 2023/4546
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 9, 2023
Est. completion date April 1, 2024

Study information

Verified date March 2024
Source Konya Necmettin Erbakan Üniversitesi
Contact Alper Kilicaslan
Phone +905053780376
Email dralperkilicaslan@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 3200
Est. completion date April 1, 2024
Est. primary completion date March 30, 2024
Accepts healthy volunteers No
Gender All
Age group 1 Year to 12 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Alper KILICASLAN Konya
Turkey Necmettin Erbakan University Konya

Sponsors (1)

Lead Sponsor Collaborator
Konya Necmettin Erbakan Üniversitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence of difficulty in supraglottic airway device(SGA) placement 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) Immediately after the attempt of insertion and up to the end of the surgery
Secondary Risk factors for pediatric difficult SGA placement 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 At the beginning of anesthesia
Secondary The incidence of complications related to SGA insertion 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 Up to 24 hours after surgery
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