AOU Mater Domini
Catanzaro, Italy
NCT Number: NCT04016480
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Catanzaro, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 will be administered through nasal cannula with a oxygen flow set to achieve a peripheral oxygen saturation equal or greater than 94%
Time frame: After 0 minute from the end of the bronchial endoscopy
Arterial blood will be sample for gas analysis
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
Time frame: After 0 minute from enrollment
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
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
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, compared to baseline
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
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
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
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
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
change from baseline, expressed in percentage, of the tidal volume as assessed through electrical impedance tomography
Time frame: After 0 minute from enrollment
Arterial blood will be sample for gas analysis
University Magna Graecia
Other
High Flow Oxygen Therapy Through Nasal Cannula in Patients With Acute Respiratory Failure During Bronchoscopy for Bronchoalveolar Lavage
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.
Published trials that share one or more normalized conditions with this study.
NCT06876168
Acute Respiratory Failure, Infections
Lexington, Kentucky, United States
View Trial DetailsNCT02723565
Acute Respiratory Failure, Pathologic Processes
Toronto, Ontario, Canada
View Trial DetailsNCT07366541
Acute Respiratory Failure, Electrical Impedance Tomography (EIT)
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT05423301
Acute Respiratory Failure
Pessac, France
View Trial Details