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

NCT03982745 | Unknown

• 1 other identifier: 2018-335
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Difficult Intubation; Thoracic Surgery

Keywords

bonfils fiberoptic stylet; double lumen intubation; thoracic surgery; difficult intubation; difficult airway

Outcome Measures

Primary Outcomes (1)

• the efficacy of Bonfils fiberoptic stylet to perform tracheal intubation with double lumen tube after failure of standard laryngoscopy

  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

  up to 2 minutes from device insertion

Secondary Outcomes (3)

• Time to intubation,

  up to 2 minutes from device insertion

• Any complications occurred

  up to 12 hours measured from the insertion of the device

• Number of intubation attempts

  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.

Interventions

bonfils DEVICE

bonfils intubation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Università Politecnica delle Marche: lead

Study Sites (1)

AOU Ospedali Riuniti Ancona - Università Politecnica delle Marche

Ancona, 60126, Italy

RECRUITING

Study Officials

• Abele Donati, PhD, MD

  Università Politecnica delle Marche

  STUDY DIRECTOR

Central Study Contacts

Abele Donati, PhD, MD

CONTACT

0715963858; a.donati@univpm.it

Stefano Falcetta, MD

CONTACT

0715964603; falmed@libero.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 11, 2019
• Study Start: March 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: June 12, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)