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

NCT ID: NCT03836183

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-26
• Study Completion Date: 2020-02-29

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%.

Detailed Description

In thoracic surgery, it is common to use selective intubation probes to exclude from ventilation the lung operated by the surgeon. It is recommended to perform a bronchoscopy which is the reference examination to confirm the good position of these probes. The interest of systematically controlling the good position of the left selective intubation probe by fibroscopy is controversial.

The interest of ultrasound for the diagnosis of pleuro-pulmonary pathologies is certain in resuscitation and emergency context for the diagnosis of pneumothorax, haemothorax and atelectasis.

The use of pleuropulmonary ultrasound in anesthesiology is the subject of studies. Several teams used it to ensure proper endotracheal tube positioning and to diagnose selective intubation. In fact, it has been shown that to control the position of the probe more precisely, ultrasound is more efficient than auscultation.

The aim of this work is to show by a large-scale prospective study that pleuropulmonary ultrasound associated with the clinical examination confirms the exclusion of the operated lung. the absence of systematic control of the positioning of the probe by fibroscopy allow financial gain and a reduction in the risk of morbidity related to the realization of this invasive gesture.

Conditions

Thoracic; Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ultrasound

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

Group Type: OTHER

Pleuropulmonary ultrasound with clinical examination

Intervention Type: DIAGNOSTIC_TEST

Pleuropulmonary ultrasound associate with a clinical examination

Interventions

Pleuropulmonary ultrasound with clinical examination

Pleuropulmonary ultrasound associate with a clinical examination

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: collaborator

Association Pro-arte

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alabaladejo Pierre

Role: PRINCIPAL_INVESTIGATOR

CHU Grenoble Alpes

Locations

Chu grenoble alpes

Grenoble, , France

Countries

France

Other Identifiers

3-2018-EchoThorax

Identifier Type: -

Identifier Source: org_study_id