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Completed

NCT Number: NCT03836183

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

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%.

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Key information

Conditions

Thoracic Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu grenoble alpes

Grenoble, 38000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pleuropulmonary ultrasound with clinical examination

Diagnostic Test

Pleuropulmonary ultrasound associate with a clinical examination

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.

    Time frame: During peroperative period

    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.

Secondary outcomes

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

    Time frame: During peroperative period

    Only the presence of the two following non metric imaging criteria makes it possible to qualify the exclusion as correct. Ultrasound criteria : absence of pleural sliding in 2D mode, Presence of the bar code sign in TM mode.

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

    Time frame: at the end of the inclusion period, an average of 1 year

    Number of participant with the presence of the two following non metric imaging criteria makes it possible to qualify the lung exclusion as correct. Ultrasound criteria : absence of pleural sliding in 2D mode, Presence of the bar code sign in TM mode. Evaluation on ultrasonographic loops blinded registered from bronchoscopy diagnosis.

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

    Time frame: at the end of the surgery, day 1

    Quantified satisfaction scale in visual analogue scale. (from 0: worse outcome, to 10: better outcome)

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

    Time frame: During ultrasound

    absence or presence of color in the pulmonary parenchyma on the 3 movements (pulmonary fields on the axillary line of the 2 sides and left upper lobe). The absence of color corresponding to a correct exclusion.

Sponsors and collaborators

Lead sponsor

Association Pro-arte

Other

Collaborators

  • University Hospital, Grenoble

Registry information

Official study 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

Acronym: Echo-Thorax

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Feb 11, 2019
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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