Auscultation, Lus, Fob In Olv (ALFIO)

NCT03912311 | Unknown

• 1 other identifier: ALFIO2019
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be to demonstrate that, in patients undergoing elective thoracic surgery, lung ultrasound (LUS) in OR is more sensitive, specific and accurate method than thoracic auscultation, for the evaluation of OLV. The aim of the study is to demonstrate how lung ultrasound can be considered an attractive alternative to the routine use of fiberbronchoscope as a first line diagnostic tool to verify the correct position of left double lumen tube.

Conditions

Thoracic Anesthesia; Lung Ultrasound; Left Double-lumen Tube; Selective Bronchial Intubation; One-lung Ventilation; Auscultation; Flexible Bronchoscopy

Outcome Measures

Primary Outcomes (1)

• To compare trans- thoracic ultrasound method and auscultation in left selective intubation with LDLT, considering them as an alternative to fiberoptic bronchoscope use.

  Sensitivity, specificity and accuracy of ultrasound method and auscultation method as technique to verify LDLT correct placement, checked with fiberoptic bronchoscope.

  Through study completion, an average of 1 years

Secondary Outcomes (12)

• Incidence of LDLT malpositioning

  Through study completion, an average of 1 years

• Incidence of LDLT displacements after lateral positioning and during surgery

  Through study completion, an average of 1 years

• Incidence of intra- and post-operating complications

  Through study completion, an average of 1 years

• Presence/absence of lung sliding throw ultrasound scan in case of correct/incorrect position of LDLT

  Through study completion, an average of 1 years

• Presence/absence of lung pulse throw ultrasound scan in case of correct/incorrect position of LDLT

  Through study completion, an average of 1 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent elective thoracic surgery (video-assisted thoracic surgery or open thoracotomy) requiring lung isolation and endotracheally intubation by left double lumen tube

You may qualify if:

• Signed informed consent
• Age \> 18 years
• Patients who underwent elective thoracic surgery (video-assisted thoracic surgery or open thoracotomy) requiring lung isolation and endotracheally intubation by LDLT

You may not qualify if:

• Not signed informed consent
• Age \< 18 years
• Previous history of thoracic surgery
• Planned use of right double lumen tube
• Pleural diseases: pleural spill, pneumothorax, mesothelioma, previous pleurodesis
• Neuromuscular disease with proved diaphragmatic disfunction
• Thoracic subcutaneous emphysema
• Difficult endotracheally intubation or more than 3 attempts made by an experienced anesthesiologist or alternative device use
• Pregnancy
• Emergency surgery

Sponsors & Collaborators

• University of Parma: lead

Study Sites (1)

Azienda Ospedaliera-Universitaria di Parma

Parma, 43125, Italy

Location

Study Officials

• Michela Tosi, MD

  Azienda Ospedaliero-Universitaria di Parma

  PRINCIPAL INVESTIGATOR

• Massimo Maffezzoni, MD

  Università di Parma

  PRINCIPAL INVESTIGATOR

• Piercarlo Cottone, MD

  Università di Parma

  PRINCIPAL INVESTIGATOR

• Stefania Lepori, MD

  Università di Parma

  PRINCIPAL INVESTIGATOR

• Valentina Bellini, MD

  Università di Parma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena G. Bignami, MD professor

CONTACT

+390521703567; elenagiovanna.bignami@unipr.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 11, 2019
• Study Start: April 2, 2019
• Primary Completion: April 2, 2020
• Study Completion: June 2, 2020
• Last Updated: April 11, 2019

Record last verified: 2019-04

Locations

IT (1)