Acute Respiratory FailureNCT04016480
HFNC During Bronchoscopy for Bronchoalveolar Lavage
A study testing High Flow Nasal Cannula and Conventional Oxygen Therapy in people with Acute Respiratory Failure and Bronchoscopy, run by University Magna Graecia at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, Bronchoscopy, Bronchoalveolar Lavage
- What is being tested?
- High Flow Nasal Cannula and Conventional Oxygen Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 12 Sep 2019to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- need for bronchial endoscopy for bronchoalveolar lavage
Who cannot join
- 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
Show all 10Show fewer
- pregnancy
- nasal or nasopharyngeal diseases
- dementia
- lack of consent or its withdrawal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Flow Oxygen Therapy Through Nasal Cannula in Patients With Acute Respiratory Failure 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.
Read the 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.
- Being tested
- High Flow Nasal Cannula, Conventional Oxygen Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Nasal CannulaDevice
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 TherapyDevice
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%
| Study group | Role | What they receive |
|---|---|---|
| High Flow Nasal Cannula | Active comparator | 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. Receives: Device: High Flow Nasal Cannula |
| Conventional Oxygen Therapy | Active comparator | Conventional oxygen therapy will be administered through common nasal cannula with a flow up to 6 Liters per minute Receives: Device: Conventional Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial blood gases at end of the procedure
Arterial blood will be sample for gas analysis
Measured: After 0 minute from the end of the bronchial endoscopy
Secondary outcomes (11)
Respiratory effort at end of the procedure
The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction
Measured: After 0 minute from the end of the bronchial endoscopy
Respiratory effort at baseline
The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction
Measured: After 0 minute from enrollment
Respiratory effort at the beginning of the bronchoscopy
The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction
Measured: 5 minutes before the beginning of the bronchial endoscopy, while receiving the assigned treatment
Respiratory effort after bronchoscopy
The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction
Measured: After 10 minute from the end of the bronchial endoscopy
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
Measured: 5 minutes before the beginning of the bronchial endoscopy, while receiving the assigned treatment, compared to baseline
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
Measured: After 0 minute from the end of the bronchial endoscopy, compared to baseline
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
Measured: After 10 minute from the end of the bronchial endoscopy, compared to baseline
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
Measured: 5 minutes before the beginning of the bronchial endoscopy, while receiving the assigned treatment, compared to baseline
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
Measured: After 0 minute from the end of the bronchial endoscopy, compared to baseline
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
Measured: After 10 minute from the end of the bronchial endoscopy, compared to baseline
Arterial blood gases at baseline
Arterial blood will be sample for gas analysis
Measured: After 0 minute from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start12 Sep 2019
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Longhini, University Magna Graecia
- Investigators
- Federico Longhini, MD, Principal investigator, Magna Graecia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016480
- Sponsor's protocol ID
- HFNC-FBS
- Status last verified
- Dec 2020
- First submitted
- 2 Jul 2019
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The full protocol, datasets used and analysed during the current study will be available on reasonable request e-mailing the corresponding author
Publications
Albertini R, Harrel JH, Moser KM. Letter: Hypoxemia during fiberoptic bronchoscopy. Chest. 1974 Jan;65(1):117-8. doi: 10.1378/chest.65.1.117. No abstract available.
PubMed 4809326Randazzo GP, Wilson AR. Cardiopulmonary changes during flexible fiberoptic bronchoscopy. Respiration. 1976;33(2):143-9. doi: 10.1159/000193727.
PubMed 935677Pirozynski M, Sliwinski P, Radwan L, Zielinski J. Bronchoalveolar lavage: comparison of three commonly used procedures. Respiration. 1991;58(2):72-6. doi: 10.1159/000195900.
PubMed 1862254Cuquemelle E, Pham T, Papon JF, Louis B, Danin PE, Brochard L. Heated and humidified high-flow oxygen therapy reduces discomfort during hypoxemic respiratory failure. Respir Care. 2012 Oct;57(10):1571-7. doi: 10.4187/respcare.01681. Epub 2012 Mar 12.
PubMed 22417569Renda T, Corrado A, Iskandar G, Pelaia G, Abdalla K, Navalesi P. High-flow nasal oxygen therapy in intensive care and anaesthesia. Br J Anaesth. 2018 Jan;120(1):18-27. doi: 10.1016/j.bja.2017.11.010. Epub 2017 Nov 21.
PubMed 29397127Matamis D, Soilemezi E, Tsagourias M, Akoumianaki E, Dimassi S, Boroli F, Richard JC, Brochard L. Sonographic evaluation of the diaphragm in critically ill patients. Technique and clinical applications. Intensive Care Med. 2013 May;39(5):801-10. doi: 10.1007/s00134-013-2823-1. Epub 2013 Jan 24.
PubMed 23344830Zambon M, Greco M, Bocchino S, Cabrini L, Beccaria PF, Zangrillo A. Assessment of diaphragmatic dysfunction in the critically ill patient with ultrasound: a systematic review. Intensive Care Med. 2017 Jan;43(1):29-38. doi: 10.1007/s00134-016-4524-z. Epub 2016 Sep 12.
PubMed 27620292Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. doi: 10.1097/mcc.0b013e3283220e8c.
PubMed 19186406Miyagi K, Haranaga S, Higa F, Tateyama M, Fujita J. Implementation of bronchoalveolar lavage using a high-flow nasal cannula in five cases of acute respiratory failure. Respir Investig. 2014 Sep;52(5):310-4. doi: 10.1016/j.resinv.2014.06.006. Epub 2014 Jul 25.
PubMed 25169847Kim EJ, Jung CY, Kim KC. Effectiveness and Safety of High-Flow Nasal Cannula Oxygen Delivery during Bronchoalveolar Lavage in Acute Respiratory Failure Patients. Tuberc Respir Dis (Seoul). 2018 Oct;81(4):319-329. doi: 10.4046/trd.2017.0122. Epub 2018 Jun 19.
PubMed 29926546Longhini F, Pisani L, Lungu R, Comellini V, Bruni A, Garofalo E, Laura Vega M, Cammarota G, Nava S, Navalesi P. High-Flow Oxygen Therapy After Noninvasive Ventilation Interruption in Patients Recovering From Hypercapnic Acute Respiratory Failure: A Physiological Crossover Trial. Crit Care Med. 2019 Jun;47(6):e506-e511. doi: 10.1097/CCM.0000000000003740.
PubMed 30882477Longhini F, Pelaia C, Garofalo E, Bruni A, Placida R, Iaquinta C, Arrighi E, Perri G, Procopio G, Cancelliere A, Rovida S, Marrazzo G, Pelaia G, Navalesi P. High-flow nasal cannula oxygen therapy for outpatients undergoing flexible bronchoscopy: a randomised controlled trial. Thorax. 2022 Jan;77(1):58-64. doi: 10.1136/thoraxjnl-2021-217116. Epub 2021 Apr 29.
PubMed 33927023
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Oxygen Therapy Through Nasal Cannula in Patients With Acute Respiratory Failure During Bronchoscopy for Bronchoalveolar Lavage
- ClinicalTrials.gov ID
- NCT04016480
- Acronym / sponsor ID
- HFNC-FBS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- 12 Sep 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 11 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Flow Nasal Cannula | Active comparator | Device: High 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. |
| Conventional Oxygen Therapy | Active comparator | Device: Conventional Oxygen TherapyConventional oxygen therapy will be administered through common nasal cannula with a flow up to 6 Liters per minute |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- need for bronchial endoscopy for bronchoalveolar lavage
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Flow Nasal CannulaHigh 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% | Device | High Flow Nasal Cannula |
| Conventional Oxygen TherapyConventional Oxygen Therapy will be administered through nasal cannula with a oxygen flow set to achieve a peripheral oxygen saturation equal or greater than 94% | Device | Conventional Oxygen Therapy |
Primary outcome
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
11 secondary outcomes
Respiratory effort at end of the procedure
Time frame: After 0 minute from the end of the bronchial endoscopy
Respiratory effort at baseline
Time frame: After 0 minute from enrollment
Respiratory effort at the beginning of the bronchoscopy
Time frame: 5 minutes before the beginning of the bronchial endoscopy, while receiving the assigned treatment
Respiratory effort after bronchoscopy
Time frame: After 10 minute from the end of the bronchial endoscopy
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 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 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 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 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 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
Arterial blood gases at baseline
Time frame: After 0 minute from enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Background: PubMed 4809326Albertini R, Harrel JH, Moser KM. Letter: Hypoxemia during fiberoptic bronchoscopy. Chest. 1974 Jan;65(1):117-8. doi: 10.1378/chest.65.1.117. No abstract available.
- Background: PubMed 935677Randazzo GP, Wilson AR. Cardiopulmonary changes during flexible fiberoptic bronchoscopy. Respiration. 1976;33(2):143-9. doi: 10.1159/000193727.
- Background: PubMed 1862254Pirozynski M, Sliwinski P, Radwan L, Zielinski J. Bronchoalveolar lavage: comparison of three commonly used procedures. Respiration. 1991;58(2):72-6. doi: 10.1159/000195900.
- Background: PubMed 22417569Cuquemelle E, Pham T, Papon JF, Louis B, Danin PE, Brochard L. Heated and humidified high-flow oxygen therapy reduces discomfort during hypoxemic respiratory failure. Respir Care. 2012 Oct;57(10):1571-7. doi: 10.4187/respcare.01681. Epub 2012 Mar 12.
- Background: PubMed 29397127Renda T, Corrado A, Iskandar G, Pelaia G, Abdalla K, Navalesi P. High-flow nasal oxygen therapy in intensive care and anaesthesia. Br J Anaesth. 2018 Jan;120(1):18-27. doi: 10.1016/j.bja.2017.11.010. Epub 2017 Nov 21.
- Background: PubMed 23344830Matamis D, Soilemezi E, Tsagourias M, Akoumianaki E, Dimassi S, Boroli F, Richard JC, Brochard L. Sonographic evaluation of the diaphragm in critically ill patients. Technique and clinical applications. Intensive Care Med. 2013 May;39(5):801-10. doi: 10.1007/s00134-013-2823-1. Epub 2013 Jan 24.
- Background: PubMed 27620292Zambon M, Greco M, Bocchino S, Cabrini L, Beccaria PF, Zangrillo A. Assessment of diaphragmatic dysfunction in the critically ill patient with ultrasound: a systematic review. Intensive Care Med. 2017 Jan;43(1):29-38. doi: 10.1007/s00134-016-4524-z. Epub 2016 Sep 12.
- Background: PubMed 19186406Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. doi: 10.1097/mcc.0b013e3283220e8c.
- Background: PubMed 25169847Miyagi K, Haranaga S, Higa F, Tateyama M, Fujita J. Implementation of bronchoalveolar lavage using a high-flow nasal cannula in five cases of acute respiratory failure. Respir Investig. 2014 Sep;52(5):310-4. doi: 10.1016/j.resinv.2014.06.006. Epub 2014 Jul 25.
- Background: PubMed 29926546Kim EJ, Jung CY, Kim KC. Effectiveness and Safety of High-Flow Nasal Cannula Oxygen Delivery during Bronchoalveolar Lavage in Acute Respiratory Failure Patients. Tuberc Respir Dis (Seoul). 2018 Oct;81(4):319-329. doi: 10.4046/trd.2017.0122. Epub 2018 Jun 19.
- Background: PubMed 30882477Longhini F, Pisani L, Lungu R, Comellini V, Bruni A, Garofalo E, Laura Vega M, Cammarota G, Nava S, Navalesi P. High-Flow Oxygen Therapy After Noninvasive Ventilation Interruption in Patients Recovering From Hypercapnic Acute Respiratory Failure: A Physiological Crossover Trial. Crit Care Med. 2019 Jun;47(6):e506-e511. doi: 10.1097/CCM.0000000000003740.
- Derived from this study: PubMed 33927023Longhini F, Pelaia C, Garofalo E, Bruni A, Placida R, Iaquinta C, Arrighi E, Perri G, Procopio G, Cancelliere A, Rovida S, Marrazzo G, Pelaia G, Navalesi P. High-flow nasal cannula oxygen therapy for outpatients undergoing flexible bronchoscopy: a randomised controlled trial. Thorax. 2022 Jan;77(1):58-64. doi: 10.1136/thoraxjnl-2021-217116. Epub 2021 Apr 29.
- Individual participant dataSharing planned: Yes. The full protocol, datasets used and analysed during the current study will be available on reasonable request e-mailing the corresponding author
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Federico Longhini, MD principal investigator
Magna Graecia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow Nasal Cannula and Conventional Oxygen Therapy in people with Acute Respiratory Failure and Bronchoscopy, run by University Magna Graecia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial blood gases at end of the procedure (time frame: After 0 minute from the end of the bronchial endoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04016480, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2020.