Predicting Post-op Airway Complications in Pediatric Patients Using Ultrasonography

July 11, 2024 updated by: Mihrican SAYAN, Çanakkale Onsekiz Mart University

Ultrasonography-based Prediction of Post-operative Airway Complications in Pediatric Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Canakkale
      • Çanakkale, Canakkale, Turkey, 17020
        • Çanakkale Onsekiz Mart University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Association between Difference in Vocal Cord Thickness, and Postoperative Airway Complications
Time Frame: Vocal cord measurements are taken before intubation and extubation under general anesthesia, with complications assessed within the first hour postoperatively.

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

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Association Between Type of Surgery and Postoperative Airway Complications in Pediatric Patients
Time Frame: The type of surgery will be recorded at the preoperative examination, with airway complications assessed within the first hour postoperatively.

This outcome measure assesses the association between different types of surgery (categorized by anatomical regions as head-neck, musculoskeletal, abdominal) and the occurrence of postoperative airway complications (categorical: presence or absence of cough, dysphonia, symptom of laryngospasm, and sign of upper airway obstruction)

Measurement Tool:

  • Classification of surgery type based on anatomical region. The classification will be as follows: 1st category head-neck, 2nd category abdomen, 3rd category musculoskeletal system surgeries.
  • 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: Categorical (type of surgery); categorical outcome (presence/absence of airway complications).
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
Time Frame: Airway and tube diameter measurements are taken intraoperatively before intubation under general anesthesia, with complications assessed within the first hour postoperatively.

This measure assesses the association between the diffence between in the narrowest airway diameter the outer diameter of the endotracheal tube placed 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 the narrowest airway diameter.
  • The outer diameter of endotracheal tube measurement listed on the endotracheal tube packaging will be accepted.
  • 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 airway and tube diameters; categorical outcome (presence/absence of 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
Time Frame: Measurements of endotracheal tube position are taken after intubation and before extubation under general anesthesia, with complications assessed within the first hour postoperatively

This outcome measure evaluates the association between the change in the position of the endotracheal tube, as determined by ultrasonography after intubation and before 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 assess changes in the position of the endotracheal tube.

Unit of Measure:

The endotracheal tube level will recorded as:

Cricothyroid membrane, Cricoid cartilage, First tracheal cartilage, Second tracheal cartilage, Third and the other tracheal cartilages If the tube level has changed, it will be recorded as 'change present'; if it remains the same, it will be recorded as 'no change'.

Position changes are categorical (change/no change); complications are categorical outcomes(presence/absence of 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
Time Frame: Endotracheal tube position is recorded before extubation intraoperatively under general anesthesia, with complications assessed within the first hour postoperatively

: This outcome measure assesses the association between the endotracheal tube position before extubation, as determined by ultrasonography, 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 the position of the endotracheal tube.

Unit of Measure: Tube position is categorized based on anatomical landmarks (1st category, 2nd category cricothyroid membrane, 3 rd category cricoid cartilage, 4 th category first tracheal cartilage, 5 th category second tracheal cartilage, 6 th category third and other tracheal cartilages); complications are categorical outcomes (presence/absence of airway complications).
Endotracheal tube position is recorded before extubation intraoperatively under general anesthesia, with complications assessed within the first hour postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Çanakkale Onsekiz Mart University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 2, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 11, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COMU-SBF-ME-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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