Predicting Post-op Airway Complications in Pediatric Patients Using Ultrasonography

NCT06403696 | Completed

• 1 other identifier: COMU-SBF-ME-01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Laryngospasm and post-extubation stridor are major postoperative airway difficulties in pediatric patients using tracheal tubes. These conditions are frequently caused by epithelium edema and anesthesia-related problems. Because it could reveal tracheal and laryngeal issues, ultrasound is an essential method for establishing the proper endotracheal tube size and minimizing difficulties. This research focuses on the use of ultrasonography to predict and understand pediatric postoperative airway complications.

Conditions

Airway Complication of Anesthesia

Keywords

Airway Management; Ultrasonography; Pediatric Anesthesia

Outcome Measures

Primary Outcomes (2)

• Association between Difference in Vocal Cord Thickness, and Postoperative Airway Complications

  This measure assesses the association between an increase in vocal cord thickness (measured in millimeters using ultrasonography) from pre-intubation to pre-extubation, and the incidence (%) of postoperative airway complications (categorical: presence or absence of cough, dysphonia, symptom of laryngospasm, and sign of upper airway obstruction). Measurement Tool: * Ultrasonography to measure vocal cord thickness in millimeters. * The existence of post-operative airway complications is determined as follows: A post-operative airway complication is defined as cough, dysphonia, laryngospasm, or upper airway blockage within the first hour following surgery; if none of these findings are present, it is considered absent. Unit of Measure: * Millimeters for vocal cord thickness. * Categorical outcome (yes/no) for airway complications

  Vocal cord measurements are taken before intubation and extubation under general anesthesia, with complications assessed within the first hour postoperatively.

• Association between Difference in Subglottic Airway Wall Thickness, and Postoperative Airway Complications

  This measure assesses the association between an increase in subglottic airway wall thickness (measured in millimeters using ultrasonography) from pre-intubation to pre-extubation, and the incidence (%) of postoperative airway complications (categorical: presence or absence of cough, dysphonia, symptom of laryngospasm, and sign of upper airway obstruction). Measurement Tool: * Ultrasonography to measure subglottic airway wall thickness in millimeters. * The existence of post-operative airway complications is determined as follows: A post-operative airway complication is defined as cough, dysphonia, laryngospasm, or upper airway blockage within the first hour following surgery; if none of these findings are present, it is considered absent. Unit of Measure: * Millimeters for subglottic airway wall thickness. * Categorical outcome (yes/no) for airway complications

  Subglottic airway wall measurements are taken before intubation and extubation under general anesthesia, with complications assessed within the first hour postoperatively.

Secondary Outcomes (4)

• Association Between Type of Surgery and Postoperative Airway Complications in Pediatric Patients

  The type of surgery will be recorded at the preoperative examination, with airway complications assessed within the first hour postoperatively.

• Association Between the Difference in Outer Diameter of the Endotracheal Tube and the Narrowest Airway Diameter, and Postoperative Airway Complications

  Airway and tube diameter measurements are taken intraoperatively before intubation under general anesthesia, with complications assessed within the first hour postoperatively.

• Association Between Changes in Endotracheal Tube Position After Intubation and Before Extubation, and Postoperative Airway Complications

  Measurements of endotracheal tube position are taken after intubation and before extubation under general anesthesia, with complications assessed within the first hour postoperatively

• Association Between Endotracheal Tube Position Before Extubation and Postoperative Airway Complications

  Endotracheal tube position is recorded before extubation intraoperatively under general anesthesia, with complications assessed within the first hour postoperatively

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Pediatric patients aged 1-11 years undergoing surgery under general anesthesia with an ASA classification of 1-2.

You may qualify if:

• Age: 1-11 years
• Anesthesia risk class: 1-2
• Patients who have given written consent

You may not qualify if:

• Patients aged under 1 or over 11 years
• Patients undergoing emergency surgery
• Patients with skin integrity issues such as open wounds, infections, or skin lesions in the area to be examined
• Patients with laryngeal or tracheal deformities
• Patients suspected of having a difficult airway
• Patients who have previously undergone surgery on the upper airway, larynx, or trachea
• Patients with a history of reactive airway disease (asthma, bronchial hyperreactivity)
• Patients who have had an upper respiratory tract infection within the last two weeks
• Patients with an anesthesia risk class of 3 or higher
• Patients undergoing high-risk surgery

Sponsors & Collaborators

• Çanakkale Onsekiz Mart University: lead

Study Sites (1)

Canakkale Onsekiz Mart University

Çanakkale, Çanakkale, 17020, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Doctor

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 8, 2024
• Study Start: May 2, 2024
• Primary Completion: June 15, 2024
• Study Completion: July 11, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

TU (1)