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HFNC During Bronchoscopy for Bronchoalveolar Lavage

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ClinicalTrials.gov Identifier: NCT04016480
Recruitment Status : Completed
First Posted : July 11, 2019
Last Update Posted : December 4, 2020
Sponsor:
Information provided by (Responsible Party):
Federico Longhini, 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.


Condition or disease Intervention/treatment Phase
Acute Respiratory Failure Bronchoscopy Bronchoalveolar Lavage Device: High Flow Nasal Cannula Device: Conventional Oxygen Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Flow Oxygen Therapy Through Nasal Cannula in Patients With Acute Respiratory Failure During Bronchoscopy for Bronchoalveolar Lavage
Actual Study Start Date : September 12, 2019
Actual Primary Completion Date : February 28, 2020
Actual Study Completion Date : February 28, 2020


Arm Intervention/treatment
Active Comparator: High Flow Nasal Cannula
High 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.
Device: High Flow Nasal Cannula
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%

Active Comparator: Conventional Oxygen Therapy
Conventional oxygen therapy will be administered through common nasal cannula with a flow up to 6 Liters per minute
Device: Conventional Oxygen Therapy
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 Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016480


Locations
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Italy
AOU Mater Domini
Catanzaro, Italy
Sponsors and Collaborators
University Magna Graecia
Investigators
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Principal Investigator: Federico Longhini, MD Magna Graecia University
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Federico Longhini, Principal Investigator, University Magna Graecia
ClinicalTrials.gov Identifier: NCT04016480    
Other Study ID Numbers: HFNC-FBS
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The full protocol, datasets used and analysed during the current study will be available on reasonable request e-mailing the corresponding author
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: The data will be shared after results publication of indexed journal in english language
Access Criteria: On reasonable request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases