ARDS, HumanNCT06224010
Respiratory Drive and Inspiratory Effort in COVID-19 Associated ARDS
An observational study of ARDS, Human and COVID-19 Respiratory Infection, run by University of Turin, Italy at 1 site in Italy.
Trial summary
Data comparing respiratory drive and effort in critically ill patients with acute respiratory distress syndrome associated to different severity of COVID-19 penumonia (CARDS) and to other risk factors are lacking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Human, COVID-19 Respiratory Infection, COVID-19 Acute Respiratory Distress Syndrome
- What is being tested?
- Respiratory drive and effort assessment
- How many people
- 56 participants
- Where
- 1 siteItaly
- Study dates
- 21 Nov 2020to 20 Jun 2023
- Phase
- Observational
- 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
Study population: Patients with diagnosis of acute respiratory distress syndrome due to confirmed (real-time RT-PCR on nasopharyngeal swabs, or lower respiratory tract aspirates) COVID-19 (CARDS), had received invasive mechanical ventilation for more than 72 hours and were candidates for assisted ventilation. The CARDS cohort divided into 'Moderate' and 'Severe' COVID groups according to P/F ratio at ICU admission. A separate cohort of patients with ARDS by etiology different from COVID-19 (No-COVID), enrolled in previous studies and with the same inclusion and exclusion criteria.
Who may be able to join
- Patients with a diagnosis of acute respiratory distress syndrome based on the Berlin criteria.
- Patients with ARDS due to confirmed COVID-19 through real-time RT-PCR on nasopharyngeal swabs or lower respiratory tract aspirates.
- Patients who had received invasive mechanical ventilation for more than 72 hours.
- Patients who were candidates for assisted ventilation.
- Readiness for assisted ventilation, which was defined by the following criteria:
- Improvement of the condition leading to acute respiratory failure.
Show all 11Show fewer
- Positive end-expiratory pressure lower than 10 cmH2O and inspiratory oxygen fraction lower than 0.5.
- Richmond agitation sedation scale score between 0 and -3.
- Ability to trigger the ventilator, i.e., decrease pressure airway opening by more than 3-4 cmH2O during a brief (5-10 seconds) end-expiratory occlusion test.
- Hemodynamic stability without vasopressor or inotropes, except for dobutamine and norepinephrine infusion below certain thresholds (dobutamine <5 gamma/Kg/min and norepinephrine <0.3 gamma/Kg/min).
- Normothermia.
Who cannot join
- Patients affected by neurological or neuromuscular pathology and/or known phrenic nerve dysfunction.
- Patients with any contraindication to the insertion of a nasogastric tube, such as recent upper gastrointestinal surgery or esophageal varices.
- Patients < 18 years old
Trial locations and contacts
1 site in 1 country.
Italy1 site
S.C. Anestesia e Rianimazione 1U A.O.U.- Città della Salute e della Scienza, P.O. Molinette Corso Bramante 88-90
Turin, 10126
About this study
Official title: Respiratory Drive and Inspiratory Effort in COVID-19 Associated ARDS: a Multicentric Prospective Observational Study
Data comparing respiratory drive and effort in critically ill patients with acute respiratory distress syndrome associated to different severity of COVID-19 penumonia (CARDS) and to other risk factors are lacking. Objectives: To assess respiratory drive and effort of CARDS patients at the first transition from controlled to assisted spontaneous breathing. The second aim was the rate of a composite outcome including the need of higher level of sedation
Read the detailed description
Multicenter cohort study in four Italian ICU including adults with moderate and severe CARDS (PaO2/FiO2 <100 mmHg) at ICU admission. An historical cohort of patients with ARDS from various etiologies used for comparison. Respiratory drive (P0.1), diaphragm electrical activity (EAdi), inspiratory effort derived from EAdi (∆PmusEAdi) and from deflection in airway pressure occluded (ΔPocc) (PmusΔPocc), dynamic transpulmonary driving pressure (ΔPL,dyn, the difference between peak and end-expiratory transpulmonary pressure) measured under assisted ventilation.
The main ventilatory pattern variables:
- Airway Occlusion Pressure (P0.1): Measurement of the decrease in airway pressure during an end-expiratory occlusion.
- Pmus-EAdi-derived (∆Pmus, EAdi): Measurement of the pressure generated by the respiratory muscles during inspiration derived by electrical activity of the diaphragm measurements.
- Transpulmonary pressure EAdi-derived (∆Plung,dyn): difference between peak and end-expiratory transpulmonary pressure .
- Occlusive Pressure Difference (∆Pocc): Evaluation of the pressure difference between the initial and final airway opening during inspiration.
- Pmus-∆Pocc-derived (∆Pmus, ∆Pocc): Measurement of the pressure generated by the respiratory muscles during inspiration derived by ∆Pocc (∆Pocc*0.75)
- Transpulmonary driving pressure ∆Pocc derived (∆Plung, ∆Pocc): calculated as (Peak airway pressure -PEEP) - 2/3 * ∆Pocc
- Diaphragmatic Electrical Activity (EAdi): Recording of the electrical activity of the diaphragm.
- Peak EAdi (EAdiPEAK): Determination of the highest recorded value of diaphragmatic electrical activity.
- Pressure time product of the trans-diaphragmatic pressure per breath and per minute(PTP/min): the integral of Pmusc-EAdi-derived during inspiration per breath.
- Inspiratory Delay (ID): Assessment of the time delay between the start of neural inspiration and the onset of mechanical ventilation.
- Neuro-ventilatory Efficiency (NVE): Measurement of the efficiency of the neural drive to the respiratory muscles.
- Peak Airway Opening Pressure (PawPEAK): Measurement of the peak pressure in the airway during inspiration.
- Inspiratory Pressure-Time Product (PmusEAdi/b): Calculation of the work of breathing by integrating the product of diaphragmatic electrical activity and the change in airway pressure during inspiration.
- Tidal Volume (VT): Measurement of the volume of air inspired and expired during each breath.
- Respiratory Rate: Calculation of the number of breaths per minute delivered by the mechanical ventilator.
- Inspiratory and Expiratory Time (Ti,MECH and Te,MECH): Determination of the duration of mechanical inspiration and expiration.
- Inspiratory Duty Cycle (TI/TTOT-neur): Calculation of the ratio of inspiratory time to total respiratory cycle time based on neural inspiration.
- Conditions
- ARDS, Human, COVID-19 Respiratory Infection, COVID-19 Acute Respiratory Distress Syndrome, Respiratory Effort-Related Arousal, Weaning Failure, Mechanical Ventilation Complication
- Being tested
- Respiratory drive and effort assessment
- Keywords
- ARDS, COVID-19, Weaning from mechanical ventilation, Respiratory drive, Inspiratory effort, Respiratory monitoring
- Medical subject headings
- Respiratory Distress Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory drive and effort assessmentOther
The use of a neurally-adjusted ventilatory assist catheter, the measurement of electrical activity of the diaphragm, ∆Pocc, P0.1, and other ventilatory parameters to assess respiratory drive and effort in three cohorts of patients
| Study group | Role | What they receive |
|---|---|---|
| Non-COVID | * This group includes patients diagnosed with Acute Respiratory Distress Syndrome (ARDS) caused by etiologies other than COVID-19.
* ARDS was defined following Berlin criteria (2012) Receives: Other: Respiratory drive and effort assessment | |
| COVID-Moderate | * Moderate COVID indicates a less severe level of hypoxemia compared to the Severe COVID group (according to Berlin criteria).
* The moderate COVID group is further characterized by a diagnosis of moderate Acute Respiratory Distress Syndrome (ARDS), based on a P/F ratio (partial pressure of oxygen/fraction of inspired oxygen) at ICU admission.
* The diagnosis of COVID-19 in these patients was confirmed using the Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) technique.
* RT-PCR involves collecting a sample from the lower respiratory tract and detecting the presence of SARS-CoV-2 viral RNA. Receives: Other: Respiratory drive and effort assessment | |
| COVID-Severe | * The severe COVID group has a diagnosis of Acute Respiratory Distress Syndrome (ARDS)
* The severity of COVID-19 in this group is determined by a P/F ratio at ICU admission, indicating a higher level of hypoxemia and a more critical clinical condition.
* The diagnosis of COVID-19 in these patients was confirmed using the Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) technique.
* RT-PCR involves collecting a sample from the lower respiratory tract and detecting the presence of SARS-CoV-2 viral RNA. Receives: Other: Respiratory drive and effort assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory drive
Evaluation of respiratory drive using P0.1
Measured: 90 breaths
Neuroventilatory coupling
Evaluation of respiratory drive using EAdi PEAK
Measured: 90 breaths
Respiratory effort
Evaluation of respiratory drive using ∆Pmus-EAdi derived, ∆Pmus-∆Pocc derived, PTP/min
Measured: 90 breaths
Transpulmonary driving pressure
Evaluation of respiratory drive using ∆Plung, dynamic
Measured: 90 breaths
Secondary outcomes (3)
Composite outcome
Transition from light to deep sedation (Richmond agitation sedation scale from 0/-3 to -4/-5) or from assisted to controlled ventilation within 48 hours of spontaneous assisted breathing
Measured: within forty eight hour from assisted spontaneous breathing
Intensive care unit mortality
Mortality
Measured: Intensive care unit stay
Mortality
Mortality
Measured: 60 days after measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start21 Nov 2020
- Primary completion1 Jun 2023
- Study completion20 Jun 2023
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 ARDS, HumanStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vito Fanelli MD, PhD, University of Turin, Italy
- Investigators
- Vito Fanelli, MD, PhD, Principal investigator, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224010
- Sponsor's protocol ID
- CE 0084148
- Status last verified
- Jan 2024
- First submitted
- 22 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bellani G, Bronco A, Arrigoni Marocco S, Pozzi M, Sala V, Eronia N, Villa G, Foti G, Tagliabue G, Eger M, Pesenti A. Measurement of Diaphragmatic Electrical Activity by Surface Electromyography in Intubated Subjects and Its Relationship With Inspiratory Effort. Respir Care. 2018 Nov;63(11):1341-1349. doi: 10.4187/respcare.06176.
PubMed 30389829Bertoni M, Telias I, Urner M, Long M, Del Sorbo L, Fan E, Sinderby C, Beck J, Liu L, Qiu H, Wong J, Slutsky AS, Ferguson ND, Brochard LJ, Goligher EC. A novel non-invasive method to detect excessively high respiratory effort and dynamic transpulmonary driving pressure during mechanical ventilation. Crit Care. 2019 Nov 6;23(1):346. doi: 10.1186/s13054-019-2617-0.
PubMed 31694692Di Mussi R, Spadaro S, Mirabella L, Volta CA, Serio G, Staffieri F, Dambrosio M, Cinnella G, Bruno F, Grasso S. Impact of prolonged assisted ventilation on diaphragmatic efficiency: NAVA versus PSV. Crit Care. 2016 Jan 5;20:1. doi: 10.1186/s13054-015-1178-0.
PubMed 26728475Di Mussi R, Spadaro S, Volta CA, Bartolomeo N, Trerotoli P, Staffieri F, Pisani L, Iannuzziello R, Dalfino L, Murgolo F, Grasso S. Continuous assessment of neuro-ventilatory drive during 12 h of pressure support ventilation in critically ill patients. Crit Care. 2020 Nov 20;24(1):652. doi: 10.1186/s13054-020-03357-9.
PubMed 33218354Vaschetto R, Cammarota G, Colombo D, Longhini F, Grossi F, Giovanniello A, Della Corte F, Navalesi P. Effects of propofol on patient-ventilator synchrony and interaction during pressure support ventilation and neurally adjusted ventilatory assist. Crit Care Med. 2014 Jan;42(1):74-82. doi: 10.1097/CCM.0b013e31829e53dc.
PubMed 23982026
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Drive and Inspiratory Effort in COVID-19 Associated ARDS: a Multicentric Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06224010
- Acronym / sponsor ID
- CE 0084148
- Conditions
- ARDS, Human, COVID-19 Respiratory Infection, COVID-19 Acute Respiratory Distress Syndrome, Respiratory Effort-Related Arousal, Weaning Failure, Mechanical Ventilation Complication
- Keywords
- ARDS, COVID-19, Weaning from mechanical ventilation, Respiratory drive, Inspiratory effort, Respiratory monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 21 Nov 2020 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 25 Jan 2024 (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.
Data comparing respiratory drive and effort in critically ill patients with acute respiratory distress syndrome associated to different severity of COVID-19 penumonia (CARDS) and to other risk factors are lacking. Objectives: To assess respiratory drive and effort of CARDS patients at the first transition from controlled to assisted spontaneous breathing. The second aim was the rate of a composite outcome including the need of higher level of sedation
Detailed description
Multicenter cohort study in four Italian ICU including adults with moderate and severe CARDS (PaO2/FiO2 <100 mmHg) at ICU admission. An historical cohort of patients with ARDS from various etiologies used for comparison. Respiratory drive (P0.1), diaphragm electrical activity (EAdi), inspiratory effort derived from EAdi (∆PmusEAdi) and from deflection in airway pressure occluded (ΔPocc) (PmusΔPocc), dynamic transpulmonary driving pressure (ΔPL,dyn, the difference between peak and end-expiratory transpulmonary pressure) measured under assisted ventilation.
The main ventilatory pattern variables:
- Airway Occlusion Pressure (P0.1): Measurement of the decrease in airway pressure during an end-expiratory occlusion.
- Pmus-EAdi-derived (∆Pmus, EAdi): Measurement of the pressure generated by the respiratory muscles during inspiration derived by electrical activity of the diaphragm measurements.
- Transpulmonary pressure EAdi-derived (∆Plung,dyn): difference between peak and end-expiratory transpulmonary pressure .
- Occlusive Pressure Difference (∆Pocc): Evaluation of the pressure difference between the initial and final airway opening during inspiration.
- Pmus-∆Pocc-derived (∆Pmus, ∆Pocc): Measurement of the pressure generated by the respiratory muscles during inspiration derived by ∆Pocc (∆Pocc*0.75)
- Transpulmonary driving pressure ∆Pocc derived (∆Plung, ∆Pocc): calculated as (Peak airway pressure -PEEP) - 2/3 * ∆Pocc
- Diaphragmatic Electrical Activity (EAdi): Recording of the electrical activity of the diaphragm.
- Peak EAdi (EAdiPEAK): Determination of the highest recorded value of diaphragmatic electrical activity.
- Pressure time product of the trans-diaphragmatic pressure per breath and per minute(PTP/min): the integral of Pmusc-EAdi-derived during inspiration per breath.
- Inspiratory Delay (ID): Assessment of the time delay between the start of neural inspiration and the onset of mechanical ventilation.
- Neuro-ventilatory Efficiency (NVE): Measurement of the efficiency of the neural drive to the respiratory muscles.
- Peak Airway Opening Pressure (PawPEAK): Measurement of the peak pressure in the airway during inspiration.
- Inspiratory Pressure-Time Product (PmusEAdi/b): Calculation of the work of breathing by integrating the product of diaphragmatic electrical activity and the change in airway pressure during inspiration.
- Tidal Volume (VT): Measurement of the volume of air inspired and expired during each breath.
- Respiratory Rate: Calculation of the number of breaths per minute delivered by the mechanical ventilator.
- Inspiratory and Expiratory Time (Ti,MECH and Te,MECH): Determination of the duration of mechanical inspiration and expiration.
- Inspiratory Duty Cycle (TI/TTOT-neur): Calculation of the ratio of inspiratory time to total respiratory cycle time based on neural inspiration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-COVID | – | Other: Respiratory drive and effort assessment* This group includes patients diagnosed with Acute Respiratory Distress Syndrome (ARDS) caused by etiologies other than COVID-19. * ARDS was defined following Berlin criteria (2012) |
| COVID-Moderate | – | Other: Respiratory drive and effort assessment* Moderate COVID indicates a less severe level of hypoxemia compared to the Severe COVID group (according to Berlin criteria). * The moderate COVID group is further characterized by a diagnosis of moderate Acute Respiratory Distress Syndrome (ARDS), based on a P/F ratio (partial pressure of oxygen/fraction of inspired oxygen) at ICU admission. * The diagnosis of COVID-19 in these patients was confirmed using the Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) technique. * RT-PCR involves collecting a sample from the lower respiratory tract and detecting the presence of SARS-CoV-2 viral RNA. |
| COVID-Severe | – | Other: Respiratory drive and effort assessment* The severe COVID group has a diagnosis of Acute Respiratory Distress Syndrome (ARDS) * The severity of COVID-19 in this group is determined by a P/F ratio at ICU admission, indicating a higher level of hypoxemia and a more critical clinical condition. * The diagnosis of COVID-19 in these patients was confirmed using the Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) technique. * RT-PCR involves collecting a sample from the lower respiratory tract and detecting the presence of SARS-CoV-2 viral RNA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of acute respiratory distress syndrome due to confirmed (real-time RT-PCR on nasopharyngeal swabs, or lower respiratory tract aspirates) COVID-19 (CARDS), had received invasive mechanical ventilation for more than 72 hours and were candidates for assisted ventilation. The CARDS cohort divided into 'Moderate' and 'Severe' COVID groups according to P/F ratio at ICU admission. A separate cohort of patients with ARDS by etiology different from COVID-19 (No-COVID), enrolled in previous studies and with the same inclusion and exclusion criteria.
Key inclusion criteria (11 listed)
- Patients with a diagnosis of acute respiratory distress syndrome based on the Berlin criteria.
- Patients with ARDS due to confirmed COVID-19 through real-time RT-PCR on nasopharyngeal swabs or lower respiratory tract aspirates.
- Patients who had received invasive mechanical ventilation for more than 72 hours.
- Patients who were candidates for assisted ventilation.
- Improvement of the condition leading to acute respiratory failure.
Key exclusion criteria (3 listed)
- Patients affected by neurological or neuromuscular pathology and/or known phrenic nerve dysfunction.
- Patients with any contraindication to the insertion of a nasogastric tube, such as recent upper gastrointestinal surgery or esophageal varices.
- Patients < 18 years old
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 |
|---|---|---|
| Respiratory drive and effort assessmentThe use of a neurally-adjusted ventilatory assist catheter, the measurement of electrical activity of the diaphragm, ∆Pocc, P0.1, and other ventilatory parameters to assess respiratory drive and effort in three cohorts of patients | Other | COVID-Moderate, COVID-Severe, Non-COVID |
Primary outcome
Respiratory drive
Time frame: 90 breaths
Evaluation of respiratory drive using P0.1
Neuroventilatory coupling
Time frame: 90 breaths
Evaluation of respiratory drive using EAdi PEAK
Respiratory effort
Time frame: 90 breaths
Evaluation of respiratory drive using ∆Pmus-EAdi derived, ∆Pmus-∆Pocc derived, PTP/min
Transpulmonary driving pressure
Time frame: 90 breaths
Evaluation of respiratory drive using ∆Plung, dynamic
3 secondary outcomes
Composite outcome
Time frame: within forty eight hour from assisted spontaneous breathing
Intensive care unit mortality
Time frame: Intensive care unit stay
Mortality
Time frame: 60 days after measurement
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 25 Jan 2024.
- Background: PubMed 30389829Bellani G, Bronco A, Arrigoni Marocco S, Pozzi M, Sala V, Eronia N, Villa G, Foti G, Tagliabue G, Eger M, Pesenti A. Measurement of Diaphragmatic Electrical Activity by Surface Electromyography in Intubated Subjects and Its Relationship With Inspiratory Effort. Respir Care. 2018 Nov;63(11):1341-1349. doi: 10.4187/respcare.06176.
- Background: PubMed 31694692Bertoni M, Telias I, Urner M, Long M, Del Sorbo L, Fan E, Sinderby C, Beck J, Liu L, Qiu H, Wong J, Slutsky AS, Ferguson ND, Brochard LJ, Goligher EC. A novel non-invasive method to detect excessively high respiratory effort and dynamic transpulmonary driving pressure during mechanical ventilation. Crit Care. 2019 Nov 6;23(1):346. doi: 10.1186/s13054-019-2617-0.
- Background: PubMed 26728475Di Mussi R, Spadaro S, Mirabella L, Volta CA, Serio G, Staffieri F, Dambrosio M, Cinnella G, Bruno F, Grasso S. Impact of prolonged assisted ventilation on diaphragmatic efficiency: NAVA versus PSV. Crit Care. 2016 Jan 5;20:1. doi: 10.1186/s13054-015-1178-0.
- Background: PubMed 33218354Di Mussi R, Spadaro S, Volta CA, Bartolomeo N, Trerotoli P, Staffieri F, Pisani L, Iannuzziello R, Dalfino L, Murgolo F, Grasso S. Continuous assessment of neuro-ventilatory drive during 12 h of pressure support ventilation in critically ill patients. Crit Care. 2020 Nov 20;24(1):652. doi: 10.1186/s13054-020-03357-9.
- Background: PubMed 23982026Vaschetto R, Cammarota G, Colombo D, Longhini F, Grossi F, Giovanniello A, Della Corte F, Navalesi P. Effects of propofol on patient-ventilator synchrony and interaction during pressure support ventilation and neurally adjusted ventilatory assist. Crit Care Med. 2014 Jan;42(1):74-82. doi: 10.1097/CCM.0b013e31829e53dc.
- 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.
Vito Fanelli, MD, PhD principal investigator
University of Turin, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS, Human and COVID-19 Respiratory Infection, run by University of Turin, Italy 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 11 inclusion and 3 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 25 Jan 2024. 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?
Respiratory drive (time frame: 90 breaths). The study lists 4 primary outcomes in all. 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 NCT06224010, 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 25 Jan 2024.