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Completed

NCT Number: NCT04016480

HFNC During Bronchoscopy for Bronchoalveolar Lavage

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AOU Mater Domini

Catanzaro, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

High Flow Nasal Cannula

Device

High Flow Nasal Cannula will be set at 60 liters per minute of air/oxygen admixture to reach a peripheral oxygen saturation equal or greater than 94%

Conventional Oxygen Therapy

Device

Conventional Oxygen Therapy will be administered through nasal cannula with a oxygen flow set to achieve a peripheral oxygen saturation equal or greater than 94%

Primary outcomes

  1. Arterial blood gases at end of the procedure

    Time frame: After 0 minute from the end of the bronchial endoscopy

    Arterial blood will be sample for gas analysis

Secondary outcomes

  1. Respiratory effort at end of the procedure

    Time frame: After 0 minute from the end of the bronchial endoscopy

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

  2. Respiratory effort at baseline

    Time frame: After 0 minute from enrollment

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

  3. Respiratory effort at the beginning of the bronchoscopy

    Time frame: 5 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

  4. Respiratory effort after bronchoscopy

    Time frame: After 10 minute from the end of the bronchial endoscopy

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

  5. Change of end-expiratory lung impedance (dEELI) from baseline at the beginning of the bronchoscopy

    Time frame: 5 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

  6. Change of end-expiratory lung impedance (dEELI) from baseline at end of the procedure

    Time frame: After 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

  7. Change of end-expiratory lung impedance (dEELI) from baseline after bronchoscopy

    Time frame: After 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

  8. Change of tidal volume in percentage (dVt%) from baseline at the beginning of bronchoscopy

    Time frame: 5 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

  9. Change of tidal volume in percentage (dVt%) from baseline at end of the procedure

    Time frame: After 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

  10. Change of tidal volume in percentage (dVt%) from baseline after bronchoscopy

    Time frame: After 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

  11. Arterial blood gases at baseline

    Time frame: After 0 minute from enrollment

    Arterial blood will be sample for gas analysis

Sponsors and collaborators

Lead sponsor

University Magna Graecia

Other

Registry information

Official study title

High Flow Oxygen Therapy Through Nasal Cannula in Patients With Acute Respiratory Failure During Bronchoscopy for Bronchoalveolar Lavage

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 11, 2019
Registry last updated
Dec 4, 2020

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

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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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