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HFNC During Bronchoscopy for Bronchoalveolar Lavage

Primary Purpose

Acute Respiratory Failure, Bronchoscopy, Bronchoalveolar Lavage

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
High Flow Nasal Cannula
Conventional Oxygen Therapy
Sponsored by
University Magna Graecia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AOU Mater Domini

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

High Flow Nasal Cannula

Conventional Oxygen Therapy

Arm Description

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.

Conventional oxygen therapy will be administered through common nasal cannula with a flow up to 6 Liters per minute

Outcomes

Primary Outcome Measures

Arterial blood gases at end of the procedure
Arterial blood will be sample for gas analysis

Secondary Outcome Measures

Respiratory effort at end of the procedure
The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction
Respiratory effort at baseline
The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction
Respiratory effort at the beginning of the bronchoscopy
The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction
Respiratory effort after bronchoscopy
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 the beginning of the bronchoscopy
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 at end of the procedure
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 bronchoscopy
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 bronchoscopy
change from baseline, expressed in percentage, of the tidal volume as assessed through electrical impedance tomography
Change of tidal volume in percentage (dVt%) from baseline at end of the procedure
change from baseline, expressed in percentage, of the tidal volume as assessed through electrical impedance tomography
Change of tidal volume in percentage (dVt%) from baseline after bronchoscopy
change from baseline, expressed in percentage, of the tidal volume as assessed through electrical impedance tomography
Arterial blood gases at baseline
Arterial blood will be sample for gas analysis

Full Information

First Posted
July 2, 2019
Last Updated
December 2, 2020
Sponsor
University Magna Graecia
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1. Study Identification

Unique Protocol Identification Number
NCT04016480
Brief Title
HFNC During Bronchoscopy for Bronchoalveolar Lavage
Official Title
High Flow Oxygen Therapy Through Nasal Cannula in Patients With Acute Respiratory Failure During Bronchoscopy for Bronchoalveolar Lavage
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
September 12, 2019 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Magna Graecia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure, Bronchoscopy, Bronchoalveolar Lavage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Flow Nasal Cannula
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Conventional Oxygen Therapy
Arm Type
Active Comparator
Arm Description
Conventional oxygen therapy will be administered through common nasal cannula with a flow up to 6 Liters per minute
Intervention Type
Device
Intervention Name(s)
High Flow Nasal Cannula
Intervention Description
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%
Intervention Type
Device
Intervention Name(s)
Conventional Oxygen Therapy
Intervention Description
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 Measure Information:
Title
Arterial blood gases at end of the procedure
Description
Arterial blood will be sample for gas analysis
Time Frame
After 0 minute from the end of the bronchial endoscopy
Secondary Outcome Measure Information:
Title
Respiratory effort at end of the procedure
Description
The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction
Time Frame
After 0 minute from the end of the bronchial endoscopy
Title
Respiratory effort at baseline
Description
The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction
Time Frame
After 0 minute from enrollment
Title
Respiratory effort at the beginning of the bronchoscopy
Description
The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction
Time Frame
5 minutes before the beginning of the bronchial endoscopy, while receiving the assigned treatment
Title
Respiratory effort after bronchoscopy
Description
The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction
Time Frame
After 10 minute from the end of the bronchial endoscopy
Title
Change of end-expiratory lung impedance (dEELI) from baseline at the beginning of the bronchoscopy
Description
change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography
Time Frame
5 minutes before the beginning of the bronchial endoscopy, while receiving the assigned treatment, compared to baseline
Title
Change of end-expiratory lung impedance (dEELI) from baseline at end of the procedure
Description
change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography
Time Frame
After 0 minute from the end of the bronchial endoscopy, compared to baseline
Title
Change of end-expiratory lung impedance (dEELI) from baseline after bronchoscopy
Description
change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography
Time Frame
After 10 minute from the end of the bronchial endoscopy, compared to baseline
Title
Change of tidal volume in percentage (dVt%) from baseline at the beginning of bronchoscopy
Description
change from baseline, expressed in percentage, of the tidal volume as assessed through electrical impedance tomography
Time Frame
5 minutes before the beginning of the bronchial endoscopy, while receiving the assigned treatment, compared to baseline
Title
Change of tidal volume in percentage (dVt%) from baseline at end of the procedure
Description
change from baseline, expressed in percentage, of the tidal volume as assessed through electrical impedance tomography
Time Frame
After 0 minute from the end of the bronchial endoscopy, compared to baseline
Title
Change of tidal volume in percentage (dVt%) from baseline after bronchoscopy
Description
change from baseline, expressed in percentage, of the tidal volume as assessed through electrical impedance tomography
Time Frame
After 10 minute from the end of the bronchial endoscopy, compared to baseline
Title
Arterial blood gases at baseline
Description
Arterial blood will be sample for gas analysis
Time Frame
After 0 minute from enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Federico Longhini, MD
Organizational Affiliation
Magna Graecia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
AOU Mater Domini
City
Catanzaro
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The full protocol, datasets used and analysed during the current study will be available on reasonable request e-mailing the corresponding author
IPD Sharing Time Frame
The data will be shared after results publication of indexed journal in english language
IPD Sharing Access Criteria
On reasonable request
Citations:
PubMed Identifier
4809326
Citation
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HFNC During Bronchoscopy for Bronchoalveolar Lavage

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