Clinical trial NCT03836183: Pleuropulmonary Ultrasound With Clinical Examination to Check the Good Position of the Double Lumen Tube Intubation
Official title: Interest of Pleuropulmonary Ultrasound Associate With Clinical Examination to Check the Good Position of the Double Lumen Tube Intubation in Patients Undergoing Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic
Surgery
Keywords: bronchoscopy
ultrasound
thorax
Lead sponsor: Association Pro-arte
Sponsor class: OTHER
Collaborators: name: University Hospital, Grenoble
First posted: 2019-02-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: 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.
timeFrame: During peroperative period
Secondary outcomes:
measure: to evaluate the diagnostic performance of pleuropulmonary ultrasound alone to diagnose the right exclusion of the operated lung in thoracic surgery.
timeFrame: During peroperative period
measure: To evaluate the interobserver validity of pleuropulmonary ultrasound as a diagnostic test for pulmonary exclusion.
timeFrame: at the end of the inclusion period, an average of 1 year
measure: Assess the surgeon's satisfaction with lung exclusion: visual analogue scale
timeFrame: at the end of the surgery, day 1
measure: determination of the performance of color Doppler in the diagnosis of pulmonary exclusion, visually assessed by presence of colour.
timeFrame: During ultrasound
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Chu grenoble alpes
Study officials:
affiliation: CHU Grenoble Alpes
name: Alabaladejo Pierre
role: PRINCIPAL_INVESTIGATOR
References: