Ultrasonography for Prediction of Difficult Intubation and Prediction of Endotracheal Tube Size

January 5, 2017 updated by: Elif Aybike Ozmumcu, Istanbul University

Ultrasonographic Thyrohyoid Distance Measurement for Prediction of Difficult Intubation and Ultrasonographic Prediction of Pediatric Endotracheal Tube Size

Aim of our study is to evaluate the predictive value of ultrasonographic (USG) measurement of thyrohyoid distance for difficult intubation and determination of optimal endotracheal tube size by using USG in pediatric patients undergoing elective surgery.

Study Overview

Status

Status

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

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

After ethics committee approval and parental consent were obtained, 119 patients undergoing genitourinary surgery or inguinal hernia repair under general anesthesia, were included in study. Patients with head or neck anomalies, syndromic patients, patients undergoing emergency surgery and patients with a history of difficult airway were excluded from the study. Patients were grouped according to their ages; Group I (1-2 years,n=38), Group II (3-5 years,n=46) and Group III (6-8 years,n=35). USG measurements were performed following sevoflurane induction in groups I and II. In group III, USG measurements were performed following premedication with intravenous midazolam 0.05 mg/kg . Thyrohyoid distance, glottic and subglottic diameters were measured with ultrasonography. The size of the endotracheal tube according to Bae's formula ( internal diameter of Endotracheal tube = 0.705 x subglottic diameter - 0.091) was calculated and recorded. Before intubation, endotracheal tube (cuffed/uncuffed) was selected using age-related formulas. In group II, anaesthesia induction was achieved with propofol 2 mg/kg. In all groups, endotracheal intubation was achieved with fentanyl 2μg/kg and rocuronium 0.6 mg/kg. Endotracheal tube size was considered as optimal when a leak was detected at 20-30cmH₂O inflation pressures. If a resistance was felt in the subglottic region, the tube was exchanged with a smaller and was exchanged with a larger (0.5 mm) size if a leak occurred at inflation pressures lower than 20cmH₂O. Intubation duration , Cormack-Lehane scores and Intubation Difficulty Scale scores were recorded. For comparison of age related formula and Bae 's formula, only patients who were intubated with un-cuffed endotracheal tube were evaluated.

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.
Interventional

Enrollment (Anticipated)

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.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

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Study Contact Backup

Study Locations

  • Turkey
    • Fatih
      • Istanbul, Fatih, Turkey, 34098
        • Recruiting
        • Istanbul University Cerrahpasa Medical Faculty
        • Contact:

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

1 year to 8 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged between 1 and 8 years
  • Elective surgery

Exclusion Criteria:

  • Patients with head or neck abnormalities
  • Syndromic patients
  • Emergency surgery and patients with a
  • History of difficult airway
  • Allergy to ultrasound gel

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

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: Group I
Patients between 1 and 2 years
Drug: Sevoflurane
Device: Ultrasonography
Drug: intravenous midazolam
Drug: fentanyl and rocuronium
OTHER: Group II
patients between 3 and 5 years
Drug: Propofol
Drug: Sevoflurane
Device: Ultrasonography
Drug: fentanyl and rocuronium
OTHER: Group III
patients between 6 and 8 years
Drug: Sevoflurane
Device: Ultrasonography
Drug: intravenous midazolam
Drug: fentanyl and rocuronium

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
Time Frame
Evidence of difficult intubation (determined with Intubation Difficulty Scale) in patients who have short thyrohyoid distance
Time Frame: three years
three years
Consistency of endotracheal tube sizes selected with aged related formulas and with ultrasonographic measurement of subglotic diameter
Time Frame: three years
three years

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.
Istanbul 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

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.
February 1, 2013

Primary Completion (ANTICIPATED)

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.
December 1, 2017

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).
December 27, 2016

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.
January 5, 2017

First Posted (ESTIMATE)

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.
January 6, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

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.
January 6, 2017

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.
January 5, 2017

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.
January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • 0964

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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