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Double Lumen Tube Positioning With Bonfils Fiberoptic Stylet: Prospective Observational Study in 30 Adult Patients

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ClinicalTrials.gov Identifier: NCT03982745
Recruitment Status : Recruiting
First Posted : June 11, 2019
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Abele Donati, MD, Università Politecnica delle Marche

Brief Summary:
The aim of this prospective observational study is to evaluate the efficacy of Bonfils fiberoptic stylet to perform tracheal intubation with double lumen tube after failure of standard laryngoscopy in 30 adults patients scheduled for elective thoracic surgery, who require tracheal intubation with double lumen tube for One Lung Ventilation under general anesthesia in a teaching hospital operating theatre at Ospedali Riuniti Ancona (Italy).

Condition or disease Intervention/treatment
Difficult Intubation Thoracic Surgery Device: bonfils

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Efficacy of Bonfils Fiberoptic Stylet for Tracheal Intubation With Double Lumen Tube After Failure of Direct Laryngoscopy. A Prospective Study
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2020

Intervention Details:
  • Device: bonfils
    bonfils intubation


Primary Outcome Measures :
  1. the efficacy of Bonfils fiberoptic stylet to perform tracheal intubation with double lumen tube after failure of standard laryngoscopy [ Time Frame: up to 2 minutes from device insertion ]
    the success rate of the procedure defined by the correct position of the double-lumen tube in the bronchial lumen verified by a flexible fiberscope


Secondary Outcome Measures :
  1. Time to intubation, [ Time Frame: up to 2 minutes from device insertion ]
    Time in minutes measured from device insertion into the patient's mouth until the DLT will be positioned into the bronchial lumen.

  2. Any complications occurred [ Time Frame: up to 12 hours measured from the insertion of the device ]
    number of patients that axperienced desaturation, hemodynamic alterations, oral cavity-pharynx and larynx traumatism

  3. Number of intubation attempts [ Time Frame: up to 15 minutes. The maximum number of attempts allowed will be 2 for the Macintosh laryngoscope and 2 for the Bonfils fiberscope, after which, in case of failure with the both devices, the patient will be awakened. ]
    number of attempt to intubation. intubation will be considered complete when the DLT will be positioned correctly into the bronchial lumen.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Adults (patients 18 years of age) scheduled for elective thoracic surgery, who require tracheal intubation with double lumen tube (DLT) for One Lung Ventilation (OLV) under general anesthesia in a teaching hospital operating theatre at Ospedali Riuniti Ancona.

Pre-operative evaluation will be done before surgery, demographic variables will be collected and the clinical screening tests to predict a difficult airway will be performed.

Criteria

Inclusion Criteria:

  • adults (age≥18 years)
  • tracheal intubation with double lumen tube (DLT) for One Lung Ventilation (OLV) required for elective thoracic surgery under general anaesthesia

Exclusion Criteria:

  • patients undergoing emergency thoracic surgery
  • patients with predictive criteria of difficult ventilation scheduled for "awake endoscopic intubation"
  • patients with anatomical features that contraindicate direct laryngoscopy

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): NCT03982745


Contacts
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Contact: Abele Donati, PhD, MD 0715963858 a.donati@univpm.it
Contact: Stefano Falcetta, MD 0715964603 falmed@libero.it

Locations
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Italy
AOU Ospedali Riuniti Ancona - Università Politecnica delle Marche Recruiting
Ancona, Italy, 60126
Contact: Abele Donati, MD, PhD    0715964603    a.donati@univpm.it   
Sponsors and Collaborators
Università Politecnica delle Marche
Investigators
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Study Director: Abele Donati, PhD, MD Università Politecnica delle Marche

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Responsible Party: Abele Donati, MD, Director, Università Politecnica delle Marche
ClinicalTrials.gov Identifier: NCT03982745     History of Changes
Other Study ID Numbers: 2018-335
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Abele Donati, MD, Università Politecnica delle Marche:
bonfils fiberoptic stylet
double lumen intubation
thoracic surgery
difficult intubation
difficult airway