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

NCT ID: NCT03013036

Last Updated: 2017-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Intubation; Difficult or Failed

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group I

Patients between 1 and 2 years

Group Type OTHER

Ultrasonography

Intervention Type DEVICE

Sevoflurane

Intervention Type DRUG

intravenous midazolam

Intervention Type DRUG

fentanyl and rocuronium

Intervention Type DRUG

Group II

patients between 3 and 5 years

Group Type OTHER

Ultrasonography

Intervention Type DEVICE

Sevoflurane

Intervention Type DRUG

Propofol

Intervention Type DRUG

fentanyl and rocuronium

Intervention Type DRUG

Group III

patients between 6 and 8 years

Group Type OTHER

Ultrasonography

Intervention Type DEVICE

Sevoflurane

Intervention Type DRUG

intravenous midazolam

Intervention Type DRUG

fentanyl and rocuronium

Intervention Type DRUG

Interventions

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Ultrasonography

Intervention Type DEVICE

Sevoflurane

Intervention Type DRUG

intravenous midazolam

Intervention Type DRUG

Propofol

Intervention Type DRUG

fentanyl and rocuronium

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Elif Aybike Ozmumcu

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istanbul University Cerrahpasa Medical Faculty

Istanbul, Fatih, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Elif A Ozmumcu, M.D.

Role: CONTACT

00905332934202

Fatis Altindas, M.D.

Role: CONTACT

00905337785278

Facility Contacts

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Fatis Altindas, M.D.

Role: primary

00905337785278

Other Identifiers

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0964

Identifier Type: -

Identifier Source: org_study_id

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