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Measurement of the Distances of the Airway in Pediatric Population in Turkey

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ClinicalTrials.gov Identifier: NCT04533334
Recruitment Status : Recruiting
First Posted : August 31, 2020
Last Update Posted : August 31, 2020
Sponsor:
Information provided by (Responsible Party):
Kadir Melih YILMAZ, Istanbul University-Cerrahpasa

Study Description
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Brief Summary:

Pediatric patients are exposed to increased risk during general anesthesia. A myriad of problems can be encountered in the pediatric population by misplaced endotracheal tubes. Especially, during one-lung ventilation (OLV) a right-sided or left-sided tube is inserted to facilitate the surgery. However, inadvertent tube use, caused by misinterpretation of the distances of the trachea and the main bronchi, may cause unintended hypoxemia, postoperative atelectasis and even mortality.

In this study, investigators will measure aforementioned distances to facilitate double-lumen endotracheal tube placement with fiberoptic bronchoscopy (FOB) among children undergoing surgery with endotracheal tube under general anesthesia.


Condition or disease Intervention/treatment
One-lung Ventilation Anesthesia Intubation Complication Anesthesia; Adverse Effect Hypoxemia Atelectasis Endotracheal Tube Wrongly Placed During Anesthetic Procedure Procedure: FOB measurement

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measurement of the Distance Between the Orifice of the Right Upper Lobe and Carinae and Labium Oris With Fiberoptic Bronchoscopy in Pediatric Population in Turkey
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : June 1, 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
Pediatric
FOB measurement of the distance between carinae and right upper lobe and carinae and labium oris in paediatric population
 Procedure: FOB measurement
A FOB will be inserted after anesthesia induction and the distances will be measured by direct observation via the bronchoscope.


Outcome Measures
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Primary Outcome Measures :
  1. Upper/Lower Airway Ratio [ Time Frame: 1 day ]
    Ratio of the distance between labium oris to carinae and carinae to right upper lobe orifice


Secondary Outcome Measures :
  1. Correlation between patient characteristics and distances measured by FOB [ Time Frame: 1 day ]
    Correlation between age, body mass index, gender, percentiles and the distance between labium oris to carinae and carinae to right upper lobe orifice


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients undergoing general anesthesia via an endotracheal tube will be eligible for recruitment.
Criteria

Inclusion Criteria:

  • All patients undergoing general anesthesia via an endotracheal tube
  • ASA I-III

Exclusion Criteria:

  • Patients that do not meet age criteria
  • Uncontrolled asthma or hyperreactive airway
  • ASA > III
  • Unstable hemodynamics
  • Patients with tracheal or oral malignancies
  • Patients with face trauma
  • Informed consent not given
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04533334


Contacts
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Contact: Melih Yılmaz, MD +90 533 037 38 50 hobarak@gmail.com

Locations
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Turkey
Istanbul University-Cerrahpaşa Recruiting
Istanbul, Turkey, 34098
Contact: Melih Yılmaz, MD    +90 533 037 38 50    hobarak@gmail.com   
Sponsors and Collaborators
Istanbul University-Cerrahpasa
More Information
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Publications:

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Responsible Party: Kadir Melih YILMAZ, Principal Investigator, Istanbul University-Cerrahpasa
ClinicalTrials.gov Identifier: NCT04533334    
Other Study ID Numbers: 26082020
First Posted: August 31, 2020    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data available on reasonable request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kadir Melih YILMAZ, Istanbul University-Cerrahpasa:
anesthesia
one-lung ventilation
fiberoptic bronchoscopy
double-lumen endobronchial tube
Additional relevant MeSH terms:
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Pulmonary Atelectasis
Hypoxia
Signs and Symptoms, Respiratory
Lung Diseases
Respiratory Tract Diseases