Clinical trial NCT06403696: Predicting Post-op Airway Complications in Pediatric Patients Using Ultrasonography
Official title: Ultrasonography-based Prediction of Post-operative Airway Complications in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Complication of Anesthesia
Keywords: Airway Management
Ultrasonography
Pediatric Anesthesia
Lead sponsor: Çanakkale Onsekiz Mart University
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients aged 1-11 years undergoing surgery under general anesthesia with an ASA classification of 1-2.

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.

Detailed description: In pediatric patients with tracheal tubes, laryngospasm, and post-extubation stridor are the two worst-case postoperative airway complications. Post-extubation stridor is caused by cricoid ring epithelial swelling, whereas laryngospasm is an uncommon but potentially fatal condition that occurs during the induction and recovery of anesthesia. When determining the proper endotracheal tube (ETT) size and minimizing postoperative problems, ultrasonography (USG) is important since it considers factors other than ETT size and irritation, like placement, surgical manipulation, and patient-specific circumstances. By displaying laryngeal and tracheal edema and the size and location of the ETT, ultrasound helps identify, at least in part, children who may experience respiratory issues. Thus, this research aims to illustrate how ultrasound could be utilized to predict the development of postoperative airway complications and to investigate the conditions that cause them in pediatric patients.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Association between Difference in Vocal Cord Thickness, and Postoperative Airway Complications
timeFrame: Vocal cord measurements are taken before intubation and extubation under general anesthesia, with complications assessed within the first hour postoperatively.
measure: Association between Difference in Subglottic Airway Wall Thickness, and Postoperative Airway Complications
timeFrame: Subglottic airway wall measurements are taken before intubation and extubation under general anesthesia, with complications assessed within the first hour postoperatively.
Secondary outcomes:
measure: Association Between Type of Surgery and Postoperative Airway Complications in Pediatric Patients
timeFrame: The type of surgery will be recorded at the preoperative examination, with airway complications assessed within the first hour postoperatively.
measure: Association Between the Difference in Outer Diameter of the Endotracheal Tube and the Narrowest Airway Diameter, and Postoperative Airway Complications
timeFrame: Airway and tube diameter measurements are taken intraoperatively before intubation under general anesthesia, with complications assessed within the first hour postoperatively.
measure: Association Between Changes in Endotracheal Tube Position After Intubation and Before Extubation, and Postoperative Airway Complications
timeFrame: Measurements of endotracheal tube position are taken after intubation and before extubation under general anesthesia, with complications assessed within the first hour postoperatively
measure: Association Between Endotracheal Tube Position Before Extubation and Postoperative Airway Complications
timeFrame: Endotracheal tube position is recorded before extubation intraoperatively under general anesthesia, with complications assessed within the first hour postoperatively
Other outcomes:
Locations:
city: Çanakkale
country: Turkey
facility: Canakkale Onsekiz Mart University
state: Canakkale
Study officials:
References: