Pleuropulmonary Ultrasound With Clinical Examination to Check the Good Position of the Double Lumen Tube Intubation

NCT03836183 | Completed

• 1 other identifier: 3-2018-EchoThorax
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Using a new ultrasound approach, allow us to avoid the systematic use of bronchoscopy which is an invasive procedure. Although rare, several complications are known with, among other things, the occurrence of pulmonary infections, pneumothorax associated with increased pressure in the airways, atelectasis or bronchospasm. Avoid the systematic control by fibroscopy in simple cases which makes it possible to overcome the complications related to its use and its cost. The investigators want to evaluate the diagnostic value of the echographic strategy in 2 steps (2D and TM) on 3 sections (pulmonary field on the axillary line of the 2 sides and left upper lobe) associated with the clinical examination in preoperative by comparing with the gold standard: fibroscopy. Clinical examination and pleuropulmonary ultrasound should have a positive predictive value of at least 85%.

Conditions

Thoracic; Surgery

Keywords

bronchoscopy; ultrasound; thorax

Outcome Measures

Primary Outcomes (1)

• To evaluate the performance of the clinical examination associated with pleuropulmonary ultrasound in order to diagnose the correct exclusion of the operated lung in thoracic surgery.

  The presence of all these following data makes it possible to qualify the exclusion as correct. Clinical data collected : absence of vesicular murmur at the auscultation, absence of leaks (less than 10% or insufflation pressures \< 4kPa (kilopascal) for a volume of 4 -5ml / kg in spirometry, and absence of bubbles in the bubble test. Ultrasound data collected: absence of pleural slip in 2D mode, presence of the bar code sign in TM mode.

  During peroperative period

Secondary Outcomes (4)

• to evaluate the diagnostic performance of pleuropulmonary ultrasound alone to diagnose the right exclusion of the operated lung in thoracic surgery.

  During peroperative period

• To evaluate the interobserver validity of pleuropulmonary ultrasound as a diagnostic test for pulmonary exclusion.

  at the end of the inclusion period, an average of 1 year

• Assess the surgeon's satisfaction with lung exclusion: visual analogue scale

  at the end of the surgery, day 1

• determination of the performance of color Doppler in the diagnosis of pulmonary exclusion, visually assessed by presence of colour.

  During ultrasound

Study Arms (1)

ultrasound

OTHER

* ultrasound is the only study group for all the patients * pleuropulmonary ultrasound * clinical examination * fibroscopy.

Diagnostic Test: Pleuropulmonary ultrasound with clinical examination

Interventions

Pleuropulmonary ultrasound with clinical examination DIAGNOSTIC_TEST

Pleuropulmonary ultrasound associate with a clinical examination

ultrasound

Eligibility Criteria

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

You may qualify if:

• Patient will benefit from thoracic or cardiac surgery requiring selective left intubation.
• Affiliation to the French social security

You may not qualify if:

• Minor patients
• Refusal of the patient
• Patients under guardianship, curators.
• Surgery not compatible with a visualization of the pleural slip in echography: surgery of pneumothorax or liquid effusion
• History likely to disturb the detection of pleural slip on ultrasound: pneumothorax surgery
• Predictable intubation difficulties and the need for selective bronchial blocker intubation
• Pregnant or lactating women

Sponsors & Collaborators

• Association Pro-arte: lead
• University Hospital, Grenoble: collaborator

Study Sites (1)

Chu grenoble alpes

Grenoble, 38000, France

Location

MeSH Terms

Interventions

Physical Examination

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Alabaladejo Pierre

  CHU Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: February 11, 2019
• Study Start: July 26, 2018
• Primary Completion: December 31, 2019
• Study Completion: February 29, 2020
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)