Airway Complication of AnesthesiaNCT06403696
Predicting Post-op Airway Complications in Pediatric Patients Using Ultrasonography
An observational study of Airway Complication of Anesthesia, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Airway Complication of Anesthesia
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2024to 11 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 10 years
- All sexes
- Child
Study population: Pediatric patients aged 1-11 years undergoing surgery under general anesthesia with an ASA classification of 1-2.
Who may be able to join
- Age: 1-11 years
- Anesthesia risk class: 1-2
- Patients who have given written consent
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Canakkale Onsekiz Mart University
Çanakkale, Çanakkale, 17020
About this study
Official title: 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.
Read the 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.
- Conditions
- Airway Complication of Anesthesia
- Keywords
- Airway Management, Ultrasonography, Pediatric Anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
: 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).
Measured: Endotracheal tube position is recorded before extubation intraoperatively under general anesthesia, with complications assessed within the first hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start2 May 2024
- Primary completion15 Jun 2024
- Study completion11 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway Complication of AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çanakkale Onsekiz Mart University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mihrican SAYAN, Çanakkale Onsekiz Mart University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403696
- Sponsor's protocol ID
- COMU-SBF-ME-01
- Status last verified
- Jul 2024
- First submitted
- 2 May 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonography-based Prediction of Post-operative Airway Complications in Pediatric Patients
- ClinicalTrials.gov ID
- NCT06403696
- Acronym / sponsor ID
- COMU-SBF-ME-01
- Conditions
- Airway Complication of Anesthesia
- Keywords
- Airway Management, Ultrasonography, Pediatric Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Çanakkale Onsekiz Mart UniversityUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 11 Jul 2024 (actual)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Age groups
- Child
- Study population
- Pediatric patients aged 1-11 years undergoing surgery under general anesthesia with an ASA classification of 1-2.
Key inclusion criteria (3 listed)
- Age: 1-11 years
- Anesthesia risk class: 1-2
- Patients who have given written consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
4 secondary outcomes
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.
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.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Complication of Anesthesia, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.