Prognostic Factors for Difficult Intubation

July 31, 2019 updated by: Ngamjit Pattaravit, Prince of Songkla University

Prognostic Factors for Difficult Intubation in Pediatric Patients

Difficult intubation is the situation that anesthesiologists don't want to face. Sometimes, difficult intubation affects the patient's oxygen saturation and harms for life. Many studies try to identify the predictors of difficult airway in pediatric patients. In this study, the investigator team want to identify the predictors of difficult intubation in pediatric patient by using additional parameters which are including hyomental distance, sternomental distance, neck circumference, ratio of hyomental distance to Thyromental distance, ratio of hyomental distance to sternomental distance, ratio of height to neck circumference, ratio of height to thyromental distance, Ratio of height to hyomental distance.

Study Overview

Status

Status

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

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 approval from the instution's Ethics Committee, a prospective cohort study was conducted in pediatric patients aged between 1-8 years, ASA physical status I-II who were scheduled for general anesthesia in elective surgery. One day prior surgery, Children and their parents were invited to be participated in the study by using verbal invitation and flyer. After giving consent, Addition physical examinations which are the measurements of hyomental distance, sternomental distance and neck circumference were done by two independent investigators. The ratio of hyomental distance to Thyromental distance, ratio of hyomental distance to sternomental distance, ratio of height to neck circumference, ratio of height to thyromental distance and ratio of height to hyomental distance. At the day of surgery, standard general anesthesia (balance technique) was done. The child was intubated using aged appropriated laryngoscope by general anesthesiologist. Cormack-Lehane grading was used to identify the difficult intubation. (grade III and IV). Data will be analyzed by R Program. The statistically significance was set as P<0.05. Multivariate Logistic Regression analysis will be used to identify the predictors of difficult intubation.

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.
Observational

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.
660

Contacts and Locations

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

Study Locations

  • Thailand
      • Songkhla, Thailand, 90110
        • Recruiting
        • Ngamjit Pattaravit
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ngamjit Pattaravit, M.D.
        • Sub-Investigator:
          • Maneemontra Sunanand, M.D.
        • Sub-Investigator:
          • Sumidra Prathep, M.D.
        • Sub-Investigator:
          • Chanatthee Kitsiripant, M.D.

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

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients aged between 1-8 years who schedule for elective surgery and having balance Anesthesia technique for surgery

Description

Inclusion Criteria:

  • Pediatric patients aged between 1-8 years
  • Schedule for elective surgery
  • Having balance Anesthesia technique for surgery

Exclusion Criteria:

  • Having aspiration risks
  • Having history of difficult airway
  • Abnormality of cervical spine /head and neck area
  • Parental refusion

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Pediatric patients aged between 1-8 years
Pediatric patients aged between 1-8 years who scheduled for general anesthesia in elective surgery. Additional physical examinations which were including thyromental distances, hyomental distances and neck circumferences, was performed at one day prior surgery. Intubation was done by general anesthesiologist in order to grade the laryngoscopic view.
Procedure: Measurements of thyromental distances, hyomental distances and neck circumferences
thyromental distances, hyomental distances and neck circumferences using measurement tape by two independent investigators.

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
Measure Description
Time Frame
The predictors of difficult airway
Time Frame: up to 1 minutes after starting the process of intubation
Laryngoscopic view was determined by using Cormack-Lehane grading (grade III-IV) were used to identify difficult intubation situation
up to 1 minutes after starting the process of intubation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The correlation between time spent for intubation and laryngoscopic view
Time Frame: up to 10 minutes after starting the process of intubation
Laryngoscopic view was determined by using Cormack-Lehane grading (grade III-IV) were used to identify difficult intubation situation
up to 10 minutes after starting the process of intubation

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.
Prince of Songkla 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 (Actual)

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.
May 1, 2018

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, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2021

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).
July 30, 2019

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.
July 31, 2019

First Posted (Actual)

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.
August 2, 2019

Study Record Updates

Last Update Posted (Actual)

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.
August 2, 2019

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.
July 31, 2019

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.
July 1, 2019

More Information

Terms related to this study

Keywords

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.
  • difficult airway

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings