Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

CT-scan Airways Mensuration - Correlation to External Measurements (AIRWAY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02900807
Recruitment Status : Completed
First Posted : September 14, 2016
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary:

Oro-tracheal intubation is performed daily in anesthesia and in the ICU. When a patient is intubated, the endotracheal tube must be inserted into the trachea to the right depth. If the tube is not deep Inserted enough there is a risk of accidental extubation and trauma to the vocal cords by the balloon. If the tube is inserted too far there is a risk of selective intubation into the right or left mainstem bronchus, which can lead to contralateral lung atelectasis and hypoxemia.

The purpose of this study is to determine whether there is a correlation between the measurement of the airway of an adult population and criteria that would be easily accessible in daily clinical practice: the height of the patient and the size of their feet.


Condition or disease
Intubation

Layout table for study information
Study Type : Observational
Actual Enrollment : 134 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : September 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : March 23, 2017



Primary Outcome Measures :
  1. size of the patients and/or size of their feet [ Time Frame: Duration of the CT-scan : about 1 hour ]
    measured with a height chart and/or a pedometer

  2. measurement of patients' airways [ Time Frame: Duration of the CT-scan : about 1 hour ]
    Mensurations of airways measured on imaging (CT-scan)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient scheduled for a CT-scan including the airways and the upper part of the chest until the hull
Criteria

Inclusion Criteria:

  • patient scheduled for a CT-scan including the airways and the upper part of the chest at least until the carina
  • patient size between between 150 cm and 195 cm

Exclusion Criteria:

  • significant deformity of the cervical spine to accurately measure the size of patients (kyphoscoliosis...)
  • impossibility of reliably know the size of the patient
  • history of pharyngo-laryngeal surgery resulting in a significant deformity or a loss of anatomical landmarks incompatible with reliable measurements between dental arches and glottic plan (total laryngectomy...)
  • history of lung surgery not allowing reliable location of the carina (pneumonectomy, double-lung transplant)

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): NCT02900807


Locations
Layout table for location information
France
Fondation Ophtalmologique Adolphe de Rothschild
Paris, France, 75019
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
Layout table for investigator information
Study Director: Guillaume Taylor, MD Fondation OPH A de Rothschild

Layout table for additonal information
Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02900807     History of Changes
Other Study ID Numbers: GTR_2014_24
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: February 2018