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HFNC During Bronchoscopy for Bronchoalveolar Lavage

Not Applicable
Completed
Conditions
Acute Respiratory Failure
Bronchoscopy
Bronchoalveolar Lavage
Interventions
Device: Conventional Oxygen Therapy
Device: High Flow Nasal Cannula
Registration Number
NCT04016480
Lead Sponsor
University Magna Graecia
Brief Summary

The execution of diagnostic-therapeutic investigations by bronchial endoscopy can expose the patient to acute respiratory failure (ARF). In particular, the risk of hypoxemia is greater during broncho-alveolar lavage (BAL). For this reason, oxygen therapy is administered at low or high flows during the course of bronchoscopic procedures, in order to avoid hypoxemia.

Few clinical studies have demonstrated the efficacy and safety of high flow oxygen through nasal cannula (HFNC) during BAL procedures, and no study has evaluated, during bronchial endoscopy, the effects of HFNC on diaphragmatic effort (assessed with ultrasound) and aeration and ventilation of the different lung regions (assessed with electrical impedance tomography).

Therefore, investigators conceived the present randomized controlled study to evaluate possible differences existing during bronchoscopy between oxygen therapy administered with HFNC and conventional (low-flow) oxygen therapy, delivered through nasal cannula.

Detailed Description

Patients with Acute Respiratory Failure may sometimes require a bronchial endoscopy for broncho-alveolar lavage (BAL).

During the procedure, hypoxemia may worsen and oxygen may be require to avoid desaturation.

In the recent years, High-Flow through Nasal Cannula (HFNC) has been introduced in the clinical practice. HFNC delivers to the patient heated humidified air-oxygen mixture, with an inspiratory fraction of oxygen (FiO2) ranging from 21 to 100% and a flow up to 60 L/min through a large bore nasal cannula.

HFNC has some potential advantages. First of all, HFNC provides heated (37°C) and humidified (44 mg/L) air-oxygen admixture to the patient, which avoids injuries to ciliary motion, reduces the inflammatory responses associated to dry and cold gases, epithelial cell cilia damage, and airway water loss, and keeps unmodified the water content of the bronchial secretions. Second, HFNC determines a wash out from carbon dioxide of the pharyngeal dead space. Third, HFNC generates small amount (up to 8 cmH2O) of pharyngeal pressure during expiration, which drops to zero during inspiration. Fourth, HFNC guarantees a more stable FiO2, as compared to conventional oxygen therapy. Whenever the inspiratory peak flow of a patient exceeds the flow provided by a Venturi mask, the patient inhaled also part of atmospheric air.

Electrical impedance tomography (EIT) is a noninvasive imaging technique providing instantaneous monitoring of variations in overall lung volume and regional distribution of ventilation, as determined by variations over time in intrathoracic impedance, which is increased by air and reduced by fluids and cells. EIT allows determining changes in end-expiratory lung impedance (EELI), a surrogate estimate of end-expiratory lung volume, assessing global and regional distribution of Vt, and obtaining indexes of spatial distribution of ventilation.

Diaphragm ultrasound is a bedside, radiation free technique to assess the contractility of the diaphragm and the respiratory effort.

In this study investigators aim to evaluate possible differences existing during bronchoscopy between oxygen therapy administered with HFNC and conventional (low-flow) oxygen therapy, delivered through nasal cannula in terms of respiratory effort (as assessed through diaphragm ultrasound), lung aeration and ventilation distribution (as assessed with EIT) and arterial blood gases.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
36
Inclusion Criteria
  • need for bronchial endoscopy for bronchoalveolar lavage
Exclusion Criteria
  • life-threatening cardiac aritmia or acute miocardical infarction within 6 weeks
  • need for invasive or non invasive ventilation
  • presence of pneumothorax or pulmonary enphisema or bullae
  • recent (within 1 week) thoracic surgery
  • presence of chest burns
  • presence of tracheostomy
  • pregnancy
  • nasal or nasopharyngeal diseases
  • dementia
  • lack of consent or its withdrawal

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Conventional Oxygen TherapyConventional Oxygen TherapyConventional oxygen therapy will be administered through common nasal cannula with a flow up to 6 Liters per minute
High Flow Nasal CannulaHigh Flow Nasal CannulaHigh Flow Nasal cannula is a system to deliver heated and humidified oxygen with an inspired oxygen fraction between 21 and 100% through large bore nasal cannula. The system delivers a flow up to 60 liters/min.
Primary Outcome Measures
NameTimeMethod
Arterial blood gases at end of the procedureAfter 0 minute from the end of the bronchial endoscopy

Arterial blood will be sample for gas analysis

Secondary Outcome Measures
NameTimeMethod
Respiratory effort at the beginning of the bronchoscopy5 minutes before the beginning of the bronchial endoscopy, while receiving the assigned treatment

The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction

Change of tidal volume in percentage (dVt%) from baseline at end of the procedureAfter 0 minute from the end of the bronchial endoscopy, compared to baseline

change from baseline, expressed in percentage, of the tidal volume as assessed through electrical impedance tomography

Respiratory effort at end of the procedureAfter 0 minute from the end of the bronchial endoscopy

The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction

Respiratory effort at baselineAfter 0 minute from enrollment

The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction

Respiratory effort after bronchoscopyAfter 10 minute from the end of the bronchial endoscopy

The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction

Change of end-expiratory lung impedance (dEELI) from baseline at end of the procedureAfter 0 minute from the end of the bronchial endoscopy, compared to baseline

change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography

Change of end-expiratory lung impedance (dEELI) from baseline after bronchoscopyAfter 10 minute from the end of the bronchial endoscopy, compared to baseline

change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography

Change of tidal volume in percentage (dVt%) from baseline at the beginning of bronchoscopy5 minutes before the beginning of the bronchial endoscopy, while receiving the assigned treatment, compared to baseline

change from baseline, expressed in percentage, of the tidal volume as assessed through electrical impedance tomography

Change of end-expiratory lung impedance (dEELI) from baseline at the beginning of the bronchoscopy5 minutes before the beginning of the bronchial endoscopy, while receiving the assigned treatment, compared to baseline

change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography

Arterial blood gases at baselineAfter 0 minute from enrollment

Arterial blood will be sample for gas analysis

Change of tidal volume in percentage (dVt%) from baseline after bronchoscopyAfter 10 minute from the end of the bronchial endoscopy, compared to baseline

change from baseline, expressed in percentage, of the tidal volume as assessed through electrical impedance tomography

Trial Locations

Locations (1)

AOU Mater Domini

🇮🇹

Catanzaro, Italy

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