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Auscultation, Lus, Fob In Olv (ALFIO) (ALFIO)

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ClinicalTrials.gov Identifier: NCT03912311
Recruitment Status : Not yet recruiting
First Posted : April 11, 2019
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Elena Giovanna Bignami, University of Parma

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.

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

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 160 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Comparison Between Diagnostic Performances of Auscultation and Ultrasonography Respect of Fiberoptic Bronchoscopy in the Valuation of Positioning of Endotracheal Double-lumen Tube in Elective Thoracic Surgery
Estimated Study Start Date : April 2, 2019
Estimated Primary Completion Date : April 2, 2020
Estimated Study Completion Date : June 2, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound




Primary Outcome Measures :
  1. To compare trans- thoracic ultrasound method and auscultation in left selective intubation with LDLT, considering them as an alternative to fiberoptic bronchoscope use. [ Time Frame: Through study completion, an average of 1 years ]
    Sensitivity, specificity and accuracy of ultrasound method and auscultation method as technique to verify LDLT correct placement, checked with fiberoptic bronchoscope.


Secondary Outcome Measures :
  1. Incidence of LDLT malpositioning [ Time Frame: Through study completion, an average of 1 years ]
  2. Incidence of LDLT displacements after lateral positioning and during surgery [ Time Frame: Through study completion, an average of 1 years ]
  3. Incidence of intra- and post-operating complications [ Time Frame: Through study completion, an average of 1 years ]
  4. Presence/absence of lung sliding throw ultrasound scan in case of correct/incorrect position of LDLT [ Time Frame: Through study completion, an average of 1 years ]
  5. Presence/absence of lung pulse throw ultrasound scan in case of correct/incorrect position of LDLT [ Time Frame: Through study completion, an average of 1 years ]
  6. Measure of diaphragmatic displacement throw ultrasound scan in spontaneous breath and in mechanical ventilation [ Time Frame: Through study completion, an average of 1 years ]
  7. Evaluation time to perform lung ultrasound scansion during lung exclusion test [ Time Frame: Through study completion, an average of 1 years ]
  8. Evaluation time to perform auscultation during lung exclusion test. [ Time Frame: Through study completion, an average of 1 years ]
  9. Evaluation time to verifing of position of LDLT with FOB [ Time Frame: Through study completion, an average of 1 years ]
  10. Incidence of ICU admission (planned or unplanned) [ Time Frame: Through study completion, an average of 1 years ]
  11. ICU and Hospital length of stay [ Time Frame: Through study completion, an average of 1 years ]
  12. Incidence of mortality [ Time Frame: Through study completion, an average of 1 years ]


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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT03912311


Contacts
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Contact: Elena G. Bignami, MD professor +390521703567 elenagiovanna.bignami@unipr.it

Locations
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Italy
Azienda Ospedaliera-Universitaria di Parma
Parma, Italy, 43125
Sponsors and Collaborators
University of Parma
Investigators
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Principal Investigator: 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

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Responsible Party: Elena Giovanna Bignami, Professor of Anesthesiology, University of Parma
ClinicalTrials.gov Identifier: NCT03912311     History of Changes
Other Study ID Numbers: ALFIO2019
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No