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

Sponsor
Istanbul University-Cerrahpasa (Other)
Overall Status
Unknown status
CT.gov ID
NCT04533334
Collaborator
(none)
300
Enrollment
1
Location
10
Anticipated Duration (Months)
30
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Procedure: FOB measurement

Study Design

Study Type:
Observational
Anticipated 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 :
Aug 1, 2020
Anticipated Primary Completion Date :
Jan 1, 2021
Anticipated Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. Upper/Lower Airway Ratio [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 [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

Criteria

Ages Eligible for Study:
1 Year to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Istanbul University-Cerrahpaşa Istanbul Turkey 34098

Sponsors and Collaborators

  • Istanbul University-Cerrahpasa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Kadir Melih YILMAZ, Principal Investigator, Istanbul University-Cerrahpasa
ClinicalTrials.gov Identifier:
NCT04533334
Other Study ID Numbers:
  • 26082020
First Posted:
Aug 31, 2020
Last Update Posted:
Aug 31, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kadir Melih YILMAZ, Principal Investigator, Istanbul University-Cerrahpasa
anesthesia
one-lung ventilation
fiberoptic bronchoscopy
double-lumen endobronchial tube
Additional relevant MeSH terms:
Pulmonary Atelectasis
Hypoxia

Study Results

No Results Posted as of Aug 31, 2020