Acute Respiratory FailureHFNCNCT03689686
High Flow Nasal Cannulas in Children
A study testing Noninvasive Respiratory Support in people with Acute Respiratory Failure, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
Non-invasive Continuous Positive Airway Pressure (nCPAP) is widely recognized as an efficient respiratory support in infants with mild to moderate Acute Hypoxemic Respiratory Failure (AHRF). Its application results in alveolar recruitment, inflation of collapsed alveoli, and reduction of intrapulmonary shunt. Read more about this study
- Who is it for?
- Ages 15 days to 5 years
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- Noninvasive Respiratory Support
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2018to 22 Sep 2018
- 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 15 days to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- P/F<300 with oxygen mask (FiO2=0.4) for 15 minutes plus two of the followings:
- Respiratory Rate (RR)>2SD according to age
- Active contraction of respiratory muscles
- Paradoxical abdominal motion
Who cannot join
- Emergency need for intubation
- Glasgow Coma Scale <12
- Hypercapnia with pH <7.25
- Cough reflex impairment
- Upper-airway obstruction
- Facial/gastric surgery
Show all 10Show fewer
- Recurrent apnoeas
- Hemodynamic instability (need for vasopressor or inotropes)
- Pneumothorax on lung echo or chest x ray
- esophageal surgery.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Giovanna Chidini
Cernusco sul Naviglio, Milan, 20063
Giovanna Chidini, MD, +39-3463272082, giovanna.chidini@policlinico.mi.it
Giovanna Chidini, MD
About this study
Official title: Physiological Effects of High Flow Nasal Cannulas Oxygen Therapy vs Continuous Positive Airway Pressure in Pediatric Acute Respiratory Failure
Non-invasive Continuous Positive Airway Pressure (nCPAP) is widely recognized as an efficient respiratory support in infants with mild to moderate Acute Hypoxemic Respiratory Failure (AHRF).
Its application results in alveolar recruitment, inflation of collapsed alveoli, and reduction of intrapulmonary shunt. nCPAP is traditionally delivered with nasal prongs, nasal/facial mask. CPAP by helmet was introduced more recently in the clinical practice.
Read more
The helmet circuit was described in details in previously published studies. From a physiological point of view the helmet circuit could be considered the best system to deliver CPAP because of the following: 1) it is characterized by the lowest amount of leaks around the interface and mouth opening 2) airways are free from potentially obstructing devices (cannula) thus the resistance is minimized and 3) theoretically the pressure is more stable minimizing the leaks 4) it is comfortable and usually sedation is not needed.
High Flow Nasal Cannula (HFNC) is increasing in use both in adults and pediatric population. HFNC could result in several clinical benefits by reducing inspiratory effort and work of breathing, increasing end-expiratory volume and CO2 wash-out for upper airways and creating a CPAP effects of 2-3 cmH2Oin the upper airways. This CPAP effect combined with an increase in CO2 wash-out and optimal airways humidification could decrease the respiratory work of breathing and improve gas exchange. However little is known about the optimal flow rate setting to improve the respiratory mechanics and gas exchange. Recent studies have reported that HFNC in nonintubated children improves oxygenation, reduces the respiratory drive and prevent reintubation in high patient risk. However all these physiological effects during HFNC therapy are only speculative.
To address the question on the more efficient devices to support the child in the early phase of mild to moderate AHRF, the Authors designed a physiological randomized crossover study aimed at measuring the physiological effects of HFNC 2 and 3 l/Kg and helmet CPAP on the work of breathing (estimated by the esophageal Pressure Time Product, PTPes) in pediatric AHRF.
Read the detailed description
Primary end point of the study is the variation in esophageal Pressure Time Product (PTPes) across the trials of HFNC at different flow rates (2and 3 l/kg/min) and CPAP by helmet.
Study design
Physiological crossover prospective study comparing three study trials (20 mins) delivered in computer generated random order:
1- HFNC flow 2l/Kg; 2- HFNC flow 3l/Kg; 3- Helmet CPAP (fresh gas flow 35 l/min, CPAP 6 cmH2O)
Four 20 mins wash out period between trials are imposed to avoid the carry over effect one treatment on the following.
Sample size calculation and statistical analysis
The sample size was established to detect a difference at least of 30% in the primary end point, i.e. the PTP esophageal, with a Type 1 error of 0.05 and a desired power of 90% between HFNC trials compared with baseline value on oxygen mask (PTPes mean value 250 ± 65 cmH2O/s with oxygen mask vs PTPes 173 ± 62 cmH2O/s with HFNC).
The distribution data were determined using the Kolmogorov-Smirnov analysis. Normally distributed variables are expressed as mean (SD) while median and interquartile range are used to report non-normally distributed variables. Differences between variables across different treatment are tested by one-way ANOVA for repeated measures with post hoc Bonferroni comparison. Significance was taken as p < .05.
Demographic data collection and patients monitoring
At enrolment the following variable are collected: sex, age, weight, PRISM III, etiology of AHRF, comorbidities, hours before study, PICU and hospital outcome. All patients are monitored as follow: tcPO2, tcpCO2, SpO2, and EKG continuously; arterial blood pressure every 15 min; COMFORT score.
Experimental protocol.
Patients are kept in semirecumbent position. Sedation, if needed, is provided according to PICU protocol (dexmedetomidine 0.5-0.7mcg/Kg/hour) to maintain a COMFORT score between 17 and 26. The attending physician evaluated treatment failure or success during stabilization period and a PICU senior consultant not involved in the study was always present for monitoring and treating potential adverse events.
Inspired Oxygen Fraction (FiO2). FiO2 is set to obtain a peripheral oxygen saturation > 94% and then kept constant during all the study for each devices.
High Flow Nasal Cannula. In all patients, HFNC is delivered through specific pediatrics nasal prongs. FiO2 is chosen by the attending physician to target a peripheral saturation of 90-96% during oxygen facial mask breathing and kept constant during all phases. The set FiO2 during each phase is measured using a dedicated system connected to nasal cannulas.
Helmet CPAP. Helmet CPAP is delivered by high fresh gas flow circuit with helmet. The pediatric helmet is made of transparent latex-free polyvinyl chloride and is secured to a soft collar that adheres to the infant's neck. One helmet port is connected to gas source and the other to an underwater CPAP valve. There are two safety systems: a pressure monitoring device with overpressure safety valve and an anti-asphyxia valve. High fresh-gas flow (.35 L/ minute) was used to avoid CO2 rebreathing.
Esophageal Pressure monitoring A nasogastric tube equipped with an esophageal balloon is advanced through the nose to reach the stomach and inflated with 1 ml air.
The intragastric position is confirmed by the positive pressure deflections during spontaneous inspiration. The catheter is then withdrawn into the esophagus, as indicated by the appearance of cardiac artifacts and negative swings of pressure tracings during inspiration, and fixed. Waveforms of the esophageal pressure were recorded for 5 min at the end of each study phase and before starting the next one by a dedicated data acquisition system.
Randomization. Concealed randomization is conducted centrally through a computer generated block-randomization schedule. A phone-call service is available h 24/7 for patients' assignments to related group. The attending physician is not involved in the study. Medical treatment for infants with acute bronchiolitis remains unchanged for the study purpose as per standard hospital protocol.
Protocol interruption criteria. The experimental protocol will be interrupted in case of treatment failure and patient will be managed according to attending physician judgement (thus including an approach with non-invasive pressure support ventilation as intermediate step before endotracheal intubation). Criteria for endotracheal intubation includes: a-failure to maintain paO2>60mmHg with FiO2<0.6; b-clinical signs of exhaustion; c- need to protect airways and/or manage copious tracheal secretions; d-hemodynamic impairment.
- Conditions
- Acute Respiratory Failure
- Being tested
- Noninvasive Respiratory Support
- Keywords
- Noninvasive ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive Respiratory SupportDevice
Physiological crossover prospective study comparing four study trials (20 mins) delivered in computer generated random order:
- Standard Oxygen therapy with mask
- HFNC flow 2l/Kg
- HFNC flow 3l/Kg
- Helmet CPAP
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Fifteeen children with Acute Respiratory Failure admitted to a PICU, needing noninvasive respiratory support Receives: Device: Noninvasive Respiratory Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in respiratory work of breathing for each study trial
Esophageal Pressure Time Product
Measured: The last three minutes for each study trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start1 Aug 2018
- Primary completion22 Sep 2018
- Study completion22 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanna Chidini, MD, Principal investigator, Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689686
- Sponsor's protocol ID
- ID247
- Acronym
- HFNC
- Status last verified
- Sep 2018
- First submitted
- 22 Sep 2018
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chidini G, Piastra M, Marchesi T, De Luca D, Napolitano L, Salvo I, Wolfler A, Pelosi P, Damasco M, Conti G, Calderini E. Continuous positive airway pressure with helmet versus mask in infants with bronchiolitis: an RCT. Pediatrics. 2015 Apr;135(4):e868-75. doi: 10.1542/peds.2014-1142. Epub 2015 Mar 16.
PubMed 25780074Chidini G, Calderini E, Cesana BM, Gandini C, Prandi E, Pelosi P. Noninvasive continuous positive airway pressure in acute respiratory failure: helmet versus facial mask. Pediatrics. 2010 Aug;126(2):e330-6. doi: 10.1542/peds.2009-3357. Epub 2010 Jul 26.
PubMed 20660548Maggiore SM, Idone FA, Vaschetto R, Festa R, Cataldo A, Antonicelli F, Montini L, De Gaetano A, Navalesi P, Antonelli M. Nasal high-flow versus Venturi mask oxygen therapy after extubation. Effects on oxygenation, comfort, and clinical outcome. Am J Respir Crit Care Med. 2014 Aug 1;190(3):282-8. doi: 10.1164/rccm.201402-0364OC.
PubMed 25003980Mauri T, Turrini C, Eronia N, Grasselli G, Volta CA, Bellani G, Pesenti A. Physiologic Effects of High-Flow Nasal Cannula in Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2017 May 1;195(9):1207-1215. doi: 10.1164/rccm.201605-0916OC.
PubMed 27997805Milesi C, Essouri S, Pouyau R, Liet JM, Afanetti M, Portefaix A, Baleine J, Durand S, Combes C, Douillard A, Cambonie G; Groupe Francophone de Reanimation et d'Urgences Pediatriques (GFRUP). High flow nasal cannula (HFNC) versus nasal continuous positive airway pressure (nCPAP) for the initial respiratory management of acute viral bronchiolitis in young infants: a multicenter randomized controlled trial (TRAMONTANE study). Intensive Care Med. 2017 Feb;43(2):209-216. doi: 10.1007/s00134-016-4617-8. Epub 2017 Jan 26.
PubMed 28124736
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Effects of High Flow Nasal Cannulas Oxygen Therapy vs Continuous Positive Airway Pressure in Pediatric Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT03689686
- Acronym / sponsor ID
- HFNC / ID247
- Conditions
- Acute Respiratory Failure
- Keywords
- Noninvasive ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 22 Sep 2018 (actual)
- Study completion
- 22 Sep 2018 (estimated)
- First posted
- 28 Sep 2018 (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.
Non-invasive Continuous Positive Airway Pressure (nCPAP) is widely recognized as an efficient respiratory support in infants with mild to moderate Acute Hypoxemic Respiratory Failure (AHRF).
Its application results in alveolar recruitment, inflation of collapsed alveoli, and reduction of intrapulmonary shunt. nCPAP is traditionally delivered with nasal prongs, nasal/facial mask. CPAP by helmet was introduced more recently in the clinical practice.
The helmet circuit was described in details in previously published studies. From a physiological point of view the helmet circuit could be considered the best system to deliver CPAP because of the following: 1) it is characterized by the lowest amount of leaks around the interface and mouth opening 2) airways are free from potentially obstructing devices (cannula) thus the resistance is minimized and 3) theoretically the pressure is more stable minimizing the leaks 4) it is comfortable and usually sedation is not needed.
High Flow Nasal Cannula (HFNC) is increasing in use both in adults and pediatric population. HFNC could result in several clinical benefits by reducing inspiratory effort and work of breathing, increasing end-expiratory volume and CO2 wash-out for upper airways and creating a CPAP effects of 2-3 cmH2Oin the upper airways. This CPAP effect combined with an increase in CO2 wash-out and optimal airways humidification could decrease the respiratory work of breathing and improve gas exchange. However little is known about the optimal flow rate setting to improve the respiratory mechanics and gas exchange. Recent studies have reported that HFNC in nonintubated children improves oxygenation, reduces the respiratory drive and prevent reintubation in high patient risk. However all these physiological effects during HFNC therapy are only speculative.
To address the question on the more efficient devices to support the child in the early phase of mild to moderate AHRF, the Authors designed a physiological randomized crossover study aimed at measuring the physiological effects of HFNC 2 and 3 l/Kg and helmet CPAP on the work of breathing (estimated by the esophageal Pressure Time Product, PTPes) in pediatric AHRF.
Detailed description
Primary end point of the study is the variation in esophageal Pressure Time Product (PTPes) across the trials of HFNC at different flow rates (2and 3 l/kg/min) and CPAP by helmet.
Study design
Physiological crossover prospective study comparing three study trials (20 mins) delivered in computer generated random order:
1- HFNC flow 2l/Kg; 2- HFNC flow 3l/Kg; 3- Helmet CPAP (fresh gas flow 35 l/min, CPAP 6 cmH2O)
Four 20 mins wash out period between trials are imposed to avoid the carry over effect one treatment on the following.
Sample size calculation and statistical analysis
The sample size was established to detect a difference at least of 30% in the primary end point, i.e. the PTP esophageal, with a Type 1 error of 0.05 and a desired power of 90% between HFNC trials compared with baseline value on oxygen mask (PTPes mean value 250 ± 65 cmH2O/s with oxygen mask vs PTPes 173 ± 62 cmH2O/s with HFNC).
The distribution data were determined using the Kolmogorov-Smirnov analysis. Normally distributed variables are expressed as mean (SD) while median and interquartile range are used to report non-normally distributed variables. Differences between variables across different treatment are tested by one-way ANOVA for repeated measures with post hoc Bonferroni comparison. Significance was taken as p < .05.
Demographic data collection and patients monitoring
At enrolment the following variable are collected: sex, age, weight, PRISM III, etiology of AHRF, comorbidities, hours before study, PICU and hospital outcome. All patients are monitored as follow: tcPO2, tcpCO2, SpO2, and EKG continuously; arterial blood pressure every 15 min; COMFORT score.
Experimental protocol.
Patients are kept in semirecumbent position. Sedation, if needed, is provided according to PICU protocol (dexmedetomidine 0.5-0.7mcg/Kg/hour) to maintain a COMFORT score between 17 and 26. The attending physician evaluated treatment failure or success during stabilization period and a PICU senior consultant not involved in the study was always present for monitoring and treating potential adverse events.
Inspired Oxygen Fraction (FiO2). FiO2 is set to obtain a peripheral oxygen saturation > 94% and then kept constant during all the study for each devices.
High Flow Nasal Cannula. In all patients, HFNC is delivered through specific pediatrics nasal prongs. FiO2 is chosen by the attending physician to target a peripheral saturation of 90-96% during oxygen facial mask breathing and kept constant during all phases. The set FiO2 during each phase is measured using a dedicated system connected to nasal cannulas.
Helmet CPAP. Helmet CPAP is delivered by high fresh gas flow circuit with helmet. The pediatric helmet is made of transparent latex-free polyvinyl chloride and is secured to a soft collar that adheres to the infant's neck. One helmet port is connected to gas source and the other to an underwater CPAP valve. There are two safety systems: a pressure monitoring device with overpressure safety valve and an anti-asphyxia valve. High fresh-gas flow (.35 L/ minute) was used to avoid CO2 rebreathing.
Esophageal Pressure monitoring A nasogastric tube equipped with an esophageal balloon is advanced through the nose to reach the stomach and inflated with 1 ml air.
The intragastric position is confirmed by the positive pressure deflections during spontaneous inspiration. The catheter is then withdrawn into the esophagus, as indicated by the appearance of cardiac artifacts and negative swings of pressure tracings during inspiration, and fixed. Waveforms of the esophageal pressure were recorded for 5 min at the end of each study phase and before starting the next one by a dedicated data acquisition system.
Randomization. Concealed randomization is conducted centrally through a computer generated block-randomization schedule. A phone-call service is available h 24/7 for patients' assignments to related group. The attending physician is not involved in the study. Medical treatment for infants with acute bronchiolitis remains unchanged for the study purpose as per standard hospital protocol.
Protocol interruption criteria. The experimental protocol will be interrupted in case of treatment failure and patient will be managed according to attending physician judgement (thus including an approach with non-invasive pressure support ventilation as intermediate step before endotracheal intubation). Criteria for endotracheal intubation includes: a-failure to maintain paO2>60mmHg with FiO2<0.6; b-clinical signs of exhaustion; c- need to protect airways and/or manage copious tracheal secretions; d-hemodynamic impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Device: Noninvasive Respiratory SupportFifteeen children with Acute Respiratory Failure admitted to a PICU, needing noninvasive respiratory support |
Who may qualify
- Ages
- 15 days to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Respiratory Rate (RR)>2SD according to age
- Active contraction of respiratory muscles
- Paradoxical abdominal motion
Key exclusion criteria (10 listed)
- Emergency need for intubation
- Glasgow Coma Scale <12
- Hypercapnia with pH <7.25
- Cough reflex impairment
- Upper-airway obstruction
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 |
|---|---|---|
| Noninvasive Respiratory SupportPhysiological crossover prospective study comparing four study trials (20 mins) delivered in computer generated random order: 1. Standard Oxygen therapy with mask 2. HFNC flow 2l/Kg 3. HFNC flow 3l/Kg 4. Helmet CPAP | Device | Patients |
Primary outcome
Changes in respiratory work of breathing for each study trial
Time frame: The last three minutes for each study trial
Esophageal Pressure Time Product
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Results publication: PubMed 25780074Chidini G, Piastra M, Marchesi T, De Luca D, Napolitano L, Salvo I, Wolfler A, Pelosi P, Damasco M, Conti G, Calderini E. Continuous positive airway pressure with helmet versus mask in infants with bronchiolitis: an RCT. Pediatrics. 2015 Apr;135(4):e868-75. doi: 10.1542/peds.2014-1142. Epub 2015 Mar 16.
- Results publication: PubMed 20660548Chidini G, Calderini E, Cesana BM, Gandini C, Prandi E, Pelosi P. Noninvasive continuous positive airway pressure in acute respiratory failure: helmet versus facial mask. Pediatrics. 2010 Aug;126(2):e330-6. doi: 10.1542/peds.2009-3357. Epub 2010 Jul 26.
- Results publication: PubMed 25003980Maggiore SM, Idone FA, Vaschetto R, Festa R, Cataldo A, Antonicelli F, Montini L, De Gaetano A, Navalesi P, Antonelli M. Nasal high-flow versus Venturi mask oxygen therapy after extubation. Effects on oxygenation, comfort, and clinical outcome. Am J Respir Crit Care Med. 2014 Aug 1;190(3):282-8. doi: 10.1164/rccm.201402-0364OC.
- Results publication: PubMed 27997805Mauri T, Turrini C, Eronia N, Grasselli G, Volta CA, Bellani G, Pesenti A. Physiologic Effects of High-Flow Nasal Cannula in Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2017 May 1;195(9):1207-1215. doi: 10.1164/rccm.201605-0916OC.
- Results publication: PubMed 28124736Milesi C, Essouri S, Pouyau R, Liet JM, Afanetti M, Portefaix A, Baleine J, Durand S, Combes C, Douillard A, Cambonie G; Groupe Francophone de Reanimation et d'Urgences Pediatriques (GFRUP). High flow nasal cannula (HFNC) versus nasal continuous positive airway pressure (nCPAP) for the initial respiratory management of acute viral bronchiolitis in young infants: a multicenter randomized controlled trial (TRAMONTANE study). Intensive Care Med. 2017 Feb;43(2):209-216. doi: 10.1007/s00134-016-4617-8. Epub 2017 Jan 26.
- Individual participant dataSharing planned: No
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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.
Giovanna Chidini, MD principal investigator
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive Respiratory Support in people with Acute Respiratory Failure, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico 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 4 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: status not confirmed, as of the sponsor's last update on 28 Sep 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giovanna Chidini, MD (+39-2-55032242, giovanna.chidini@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in respiratory work of breathing for each study trial (time frame: The last three minutes for each study trial). 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 NCT03689686, which also lists 5 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 28 Sep 2018.