NCT02900807

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2017

Completed
Last Updated

August 9, 2018

Status Verified

February 1, 2018

Enrollment Period

3 months

First QC Date

September 7, 2016

Last Update Submit

August 8, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • size of the patients and/or size of their feet

    measured with a height chart and/or a pedometer

    Duration of the CT-scan : about 1 hour

  • measurement of patients' airways

    Mensurations of airways measured on imaging (CT-scan)

    Duration of the CT-scan : about 1 hour

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient scheduled for a CT-scan including the airways and the upper part of the chest until the hull

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

Study Officials

  • Guillaume Taylor, MD

    Fondation OPH A de Rothschild

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2016

First Posted

September 14, 2016

Study Start

September 1, 2014

Primary Completion

December 1, 2014

Study Completion

March 23, 2017

Last Updated

August 9, 2018

Record last verified: 2018-02

Locations