Acute Respiratory FailureNPS_LowCrsNCT05566652
Neural Pressure Support for Low Pulmonary Compliance
A study testing Neural Pressure Support and Pressure Support Ventilation in people with Acute Respiratory Failure, run by Policlinico Hospital at 1 site in Italy.
Trial summary
With this interventional prospective study, we aim at comparing the effectiveness of Neural Pressure Support (NPS) in reducing respiratory work and patient-ventilator asynchronies as compared with standard Pressure Support Ventilation (PSV), in a cohort of patients with Acute Respiratory Failure (ARF) and low… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- Neural Pressure Support and Pressure Support Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2022to 31 Oct 2023
- 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
- Age > 18 years
- Admission to Intensive Care Unit (ICU) for ARF
- Low compliance of the respiratory system (Crs ≤ 30 ml/cmH2O)
- Written informed consent obtained
Who cannot join
- Contraindication to nasogastric tube insertion (gastroesophageal surgery in the previous 3 months, gastroesophageal bleeding in the previous 30 days, history of esophageal varices, facial trauma)
- Increased risk of bleeding with nasogastric tube insertion, due to severe coagulation disorders and severe thrombocytopenia ( i.e., International Normalized Ratio (INR) > 2 and platelets count < 70.000/mm3)
- Severe hemodynamic instability (noradrenaline > 0.3 μg/kg/min and/or use of vasopressin)
- Failure to obtain a stable EAdi signal
- Central nervous system or neuromuscular disorders
- Moribund status
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico
Milan, 20100
Giacomo Grasselli, MD, +390255033285, giacomo.grasselli@unimi.it
About this study
With this interventional prospective study, we aim at comparing the effectiveness of Neural Pressure Support (NPS) in reducing respiratory work and patient-ventilator asynchronies as compared with standard Pressure Support Ventilation (PSV), in a cohort of patients with Acute Respiratory Failure (ARF) and low respiratory system compliance.
Read the detailed description
Acute respiratory failure (ARF) is a critical condition caused by impaired function of the lungs.1,2 The cornerstone of ARF management is invasive mechanical ventilation (IMV).3,4 Unfortunately, despite lifesaving, IMV is associated with several side effects (e.g., ventilator-associated pneumonia, ventilator associate induced lung injury, diaphragmatic dysfunction), and thus liberation from invasive mechanical ventilation is an everyday effort for critical care physicians.5
Pressure support ventilation (PSV) is one of the most widely used mechanical ventilation modes for liberation from IMV.6 PSV is a partial ventilatory mode: the ventilator and the patient co-operate to generate the inspiratory and expiratory pressures, flows, and volumes. During conventional PSV, the initiation of the breath is triggered by a reduction in expiratory pressure or a drop in expiratory flow.7 The termination of the breath occurs when the inspiratory flow falls to a predetermined fraction of the peak inspiratory flow.8
The main goal of mechanical ventilation is to help restore gas exchange and reduce the work of breathing (WOB) by assisting respiratory muscle activity.9 Knowing the determinants of WOB is essential for the effective use of mechanical ventilation and also to assess patient readiness for weaning. To reduce WOB, PSV needs to be synchronous and smooth interaction should happen between the ventilator and the respiratory muscles.10
Ideally, the ventilator trigger and cycling should coincide with the beginning and end of the patient's inspiratory effort.11 However, patient-ventilator asynchrony is common during PSV,12,13 thereby contributing to an increased work of breathing and an increased duration of mechanical ventilation.14
An important objective of assisted or patient-triggered mechanical ventilation is to avoid ventilator-induced diaphragmatic dysfunction by allowing the patient to generate spontaneous efforts.15 A second objective is to reduce the patient's work of breathing by delivering a sufficient level of ventilatory support.16 Finally, intuition suggests that a good match between patient respiratory efforts and ventilator breaths optimizes patient comfort and reduces work of breathing.17 Patient-ventilator asynchrony can be defined as a mismatch between the patient and ventilator inspiratory and expiratory times.18 Although inspiratory and expiratory delays are almost inevitable with most ventilatory modes, several patterns of major asynchrony exist and can be easily detected by clinicians.14
The diaphragmatic electrical activity (EAdi) can be used to optimize the ventilator settings and improve the matching between patient and ventilator. The EAdi signal is a surrogate of respiratory brain stem output and can be recorded using specialized nasogastric tubes equipped with electrodes.19
The Neural Pressure Support (NPS) is a newer ventilation mode that includes neural trigger and termination of inspiration based on the electrical activity of the diaphragm (Edi). NPS delivers a constant airway pressure support independent of the patient's efforts.20
The NPS may be particularly beneficial for ARF patients with lower respiratory compliance. Indeed, in this cohort, during standard PSV, expiratory cycling may be hampered by several asynchronies.21 However, to our knowledge, the effectiveness of NPS in reducing asynchronies and respiratory work has not been tested and compared with standard PSV in patients with low respiratory system compliance.
- Conditions
- Acute Respiratory Failure
- Being tested
- Neural Pressure Support, Pressure Support Ventilation
- Keywords
- NPS, WOB, AI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural Pressure SupportDevice
To evaluate WOB and asynchronies in patients with low respiratory system compliance undergoing either PSV and NPS.
Pressure Support VentilationDrug
To evaluate WOB and asynchronies in patients with low respiratory system compliance undergoing either PSV and NPS.
| Study group | Role | What they receive |
|---|---|---|
| NPS | Experimental | To evaluate WOB and asynchronies in patients with low respiratory system compliance undergoing Neural Pressure Support Ventilation. Receives: Device: Neural Pressure Support; Drug: Pressure Support Ventilation |
| PSV | Sham comparator | To evaluate WOB and asynchronies in patients with low respiratory system compliance undergoing Pressure Support Ventilation. Receives: Device: Neural Pressure Support; Drug: Pressure Support Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work Of Breathing (WOB)
We hypothesize that Neural Pressure Support (NPS) is able to improve the patient-ventilator interaction, thus reducing significantly the patient's work of breathing (WOB). WOB will be evaluated by the off-line analysis of the esophageal pressure waveform.
Measured: 30 minutes ventilatory traces recording
Secondary outcomes (1)
Asynchronies
We hypothesize that Neural Pressure Support (NPS) is able to improve the patient-ventilator interaction, thus reducing significantly the asynchronies between patient and ventilator. Asynchronies will be estimated by the Asynchrony Index (AI) calculated off-line by ventilatory waveforms analysis.
Measured: 30 minutes ventilatory traces recording
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start1 Dec 2022
- Primary completion31 May 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)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
- Non-randomised
- Intervention model
- Crossover
- Model description
- This is an interventional prospective crossover physiological study that will take place at the Intensive Care Unit "E. Vecla", Department of Anesthesia, Intensive Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giacomo Grasselli, Policlinico Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566652
- Sponsor's protocol ID
- NPS
- Acronym
- NPS_LowCrs
- Status last verified
- Dec 2022
- First submitted
- 13 Sep 2022
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the International Council for Harmonisation of Technical Requirements (ICH) guidelines for the Good Clinical Practice (GCP), the monitoring team must check the Case Report Form (CRF) entries against source documents. The personnel bound by professional secret, must maintain the confidentiality of all personal identity or personal medical information. The confidentiality of records that could identify subjects should be protected, only initials of the name and the first name will be registered with a inclusion coded number for the study (no name nor address nor identifying data). Paper-based CRF will be designed by the PI. A unique code will be assigned to each participant in order to de-identify the data. It is the Investigator's responsibility to ensure the accuracy of all data entered and recorded in the CRFs. The database will be password protected and stored on a password-protected Personal Computer in a research office in the critical care department.
Publications
Thompson BT, Chambers RC, Liu KD. Acute Respiratory Distress Syndrome. N Engl J Med. 2017 Aug 10;377(6):562-572. doi: 10.1056/NEJMra1608077. No abstract available.
PubMed 28792873Meyer NJ, Gattinoni L, Calfee CS. Acute respiratory distress syndrome. Lancet. 2021 Aug 14;398(10300):622-637. doi: 10.1016/S0140-6736(21)00439-6. Epub 2021 Jul 1.
PubMed 34217425Yoshida T, Fujino Y, Amato MB, Kavanagh BP. Fifty Years of Research in ARDS. Spontaneous Breathing during Mechanical Ventilation. Risks, Mechanisms, and Management. Am J Respir Crit Care Med. 2017 Apr 15;195(8):985-992. doi: 10.1164/rccm.201604-0748CP.
PubMed 27786562Pelosi P, Ball L, Barbas CSV, Bellomo R, Burns KEA, Einav S, Gattinoni L, Laffey JG, Marini JJ, Myatra SN, Schultz MJ, Teboul JL, Rocco PRM. Personalized mechanical ventilation in acute respiratory distress syndrome. Crit Care. 2021 Jul 16;25(1):250. doi: 10.1186/s13054-021-03686-3.
PubMed 34271958Fan E, Del Sorbo L, Goligher EC, Hodgson CL, Munshi L, Walkey AJ, Adhikari NKJ, Amato MBP, Branson R, Brower RG, Ferguson ND, Gajic O, Gattinoni L, Hess D, Mancebo J, Meade MO, McAuley DF, Pesenti A, Ranieri VM, Rubenfeld GD, Rubin E, Seckel M, Slutsky AS, Talmor D, Thompson BT, Wunsch H, Uleryk E, Brozek J, Brochard LJ; American Thoracic Society, European Society of Intensive Care Medicine, and Society of Critical Care Medicine. An Official American Thoracic Society/European Society of Intensive Care Medicine/Society of Critical Care Medicine Clinical Practice Guideline: Mechanical Ventilation in Adult Patients with Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2017 May 1;195(9):1253-1263. doi: 10.1164/rccm.201703-0548ST.
PubMed 28459336Hess DR. Ventilator waveforms and the physiology of pressure support ventilation. Respir Care. 2005 Feb;50(2):166-86; discussion 183-6.
PubMed 15691390Spahija J, de Marchie M, Albert M, Bellemare P, Delisle S, Beck J, Sinderby C. Patient-ventilator interaction during pressure support ventilation and neurally adjusted ventilatory assist. Crit Care Med. 2010 Feb;38(2):518-26. doi: 10.1097/CCM.0b013e3181cb0d7b.
PubMed 20083921MacIntyre NR. Clinically available new strategies for mechanical ventilatory support. Chest. 1993 Aug;104(2):560-5. doi: 10.1378/chest.104.2.560. No abstract available.
PubMed 8339649Nava S, Bruschi C, Rubini F, Palo A, Iotti G, Braschi A. Respiratory response and inspiratory effort during pressure support ventilation in COPD patients. Intensive Care Med. 1995 Nov;21(11):871-9. doi: 10.1007/BF01712327.
PubMed 8636518Leung P, Jubran A, Tobin MJ. Comparison of assisted ventilator modes on triggering, patient effort, and dyspnea. Am J Respir Crit Care Med. 1997 Jun;155(6):1940-8. doi: 10.1164/ajrccm.155.6.9196100.
PubMed 9196100Yamada Y, Du HL. Analysis of the mechanisms of expiratory asynchrony in pressure support ventilation: a mathematical approach. J Appl Physiol (1985). 2000 Jun;88(6):2143-50. doi: 10.1152/jappl.2000.88.6.2143.
PubMed 10846029Tokioka H, Tanaka T, Ishizu T, Fukushima T, Iwaki T, Nakamura Y, Kosogabe Y. The effect of breath termination criterion on breathing patterns and the work of breathing during pressure support ventilation. Anesth Analg. 2001 Jan;92(1):161-5. doi: 10.1097/00000539-200101000-00031.
PubMed 11133620Tassaux D, Gainnier M, Battisti A, Jolliet P. Impact of expiratory trigger setting on delayed cycling and inspiratory muscle workload. Am J Respir Crit Care Med. 2005 Nov 15;172(10):1283-9. doi: 10.1164/rccm.200407-880OC. Epub 2005 Aug 18.
PubMed 16109983Thille AW, Rodriguez P, Cabello B, Lellouche F, Brochard L. Patient-ventilator asynchrony during assisted mechanical ventilation. Intensive Care Med. 2006 Oct;32(10):1515-22. doi: 10.1007/s00134-006-0301-8. Epub 2006 Aug 1.
PubMed 16896854Vassilakopoulos T, Petrof BJ. Ventilator-induced diaphragmatic dysfunction. Am J Respir Crit Care Med. 2004 Feb 1;169(3):336-41. doi: 10.1164/rccm.200304-489CP. No abstract available.
PubMed 14739134
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Pressure Support for Low Pulmonary Compliance
- ClinicalTrials.gov ID
- NCT05566652
- Acronym / sponsor ID
- NPS_LowCrs / NPS
- Conditions
- Acute Respiratory Failure
- Keywords
- NPS, WOB, AI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 4 Oct 2022 (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.
With this interventional prospective study, we aim at comparing the effectiveness of Neural Pressure Support (NPS) in reducing respiratory work and patient-ventilator asynchronies as compared with standard Pressure Support Ventilation (PSV), in a cohort of patients with Acute Respiratory Failure (ARF) and low respiratory system compliance.
Detailed description
Acute respiratory failure (ARF) is a critical condition caused by impaired function of the lungs.1,2 The cornerstone of ARF management is invasive mechanical ventilation (IMV).3,4 Unfortunately, despite lifesaving, IMV is associated with several side effects (e.g., ventilator-associated pneumonia, ventilator associate induced lung injury, diaphragmatic dysfunction), and thus liberation from invasive mechanical ventilation is an everyday effort for critical care physicians.5
Pressure support ventilation (PSV) is one of the most widely used mechanical ventilation modes for liberation from IMV.6 PSV is a partial ventilatory mode: the ventilator and the patient co-operate to generate the inspiratory and expiratory pressures, flows, and volumes. During conventional PSV, the initiation of the breath is triggered by a reduction in expiratory pressure or a drop in expiratory flow.7 The termination of the breath occurs when the inspiratory flow falls to a predetermined fraction of the peak inspiratory flow.8
The main goal of mechanical ventilation is to help restore gas exchange and reduce the work of breathing (WOB) by assisting respiratory muscle activity.9 Knowing the determinants of WOB is essential for the effective use of mechanical ventilation and also to assess patient readiness for weaning. To reduce WOB, PSV needs to be synchronous and smooth interaction should happen between the ventilator and the respiratory muscles.10
Ideally, the ventilator trigger and cycling should coincide with the beginning and end of the patient's inspiratory effort.11 However, patient-ventilator asynchrony is common during PSV,12,13 thereby contributing to an increased work of breathing and an increased duration of mechanical ventilation.14
An important objective of assisted or patient-triggered mechanical ventilation is to avoid ventilator-induced diaphragmatic dysfunction by allowing the patient to generate spontaneous efforts.15 A second objective is to reduce the patient's work of breathing by delivering a sufficient level of ventilatory support.16 Finally, intuition suggests that a good match between patient respiratory efforts and ventilator breaths optimizes patient comfort and reduces work of breathing.17 Patient-ventilator asynchrony can be defined as a mismatch between the patient and ventilator inspiratory and expiratory times.18 Although inspiratory and expiratory delays are almost inevitable with most ventilatory modes, several patterns of major asynchrony exist and can be easily detected by clinicians.14
The diaphragmatic electrical activity (EAdi) can be used to optimize the ventilator settings and improve the matching between patient and ventilator. The EAdi signal is a surrogate of respiratory brain stem output and can be recorded using specialized nasogastric tubes equipped with electrodes.19
The Neural Pressure Support (NPS) is a newer ventilation mode that includes neural trigger and termination of inspiration based on the electrical activity of the diaphragm (Edi). NPS delivers a constant airway pressure support independent of the patient's efforts.20
The NPS may be particularly beneficial for ARF patients with lower respiratory compliance. Indeed, in this cohort, during standard PSV, expiratory cycling may be hampered by several asynchronies.21 However, to our knowledge, the effectiveness of NPS in reducing asynchronies and respiratory work has not been tested and compared with standard PSV in patients with low respiratory system compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an interventional prospective crossover physiological study that will take place at the Intensive Care Unit "E. Vecla", Department of Anesthesia, Intensive Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
| Arm | Type | Receives |
|---|---|---|
| NPS | Experimental | Device: Neural Pressure Support, Drug: Pressure Support VentilationTo evaluate WOB and asynchronies in patients with low respiratory system compliance undergoing Neural Pressure Support Ventilation. |
| PSV | Sham comparator | Device: Neural Pressure Support, Drug: Pressure Support VentilationTo evaluate WOB and asynchronies in patients with low respiratory system compliance undergoing Pressure Support Ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Admission to Intensive Care Unit (ICU) for ARF
- Low compliance of the respiratory system (Crs ≤ 30 ml/cmH2O)
- Written informed consent obtained
Key exclusion criteria (6 listed)
- Contraindication to nasogastric tube insertion (gastroesophageal surgery in the previous 3 months, gastroesophageal bleeding in the previous 30 days, history of esophageal varices, facial trauma)
- Increased risk of bleeding with nasogastric tube insertion, due to severe coagulation disorders and severe thrombocytopenia ( i.e., International Normalized Ratio (INR) > 2 and platelets count < 70.000/mm3)
- Severe hemodynamic instability (noradrenaline > 0.3 μg/kg/min and/or use of vasopressin)
- Failure to obtain a stable EAdi signal
- Central nervous system or neuromuscular disorders
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 |
|---|---|---|
| Neural Pressure SupportTo evaluate WOB and asynchronies in patients with low respiratory system compliance undergoing either PSV and NPS. | Device | NPS, PSV |
| Pressure Support VentilationTo evaluate WOB and asynchronies in patients with low respiratory system compliance undergoing either PSV and NPS. | Drug | NPS, PSV |
Primary outcome
Work Of Breathing (WOB)
Time frame: 30 minutes ventilatory traces recording
We hypothesize that Neural Pressure Support (NPS) is able to improve the patient-ventilator interaction, thus reducing significantly the patient's work of breathing (WOB). WOB will be evaluated by the off-line analysis of the esophageal pressure waveform.
1 secondary outcome
Asynchronies
Time frame: 30 minutes ventilatory traces recording
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Background: PubMed 28792873Thompson BT, Chambers RC, Liu KD. Acute Respiratory Distress Syndrome. N Engl J Med. 2017 Aug 10;377(6):562-572. doi: 10.1056/NEJMra1608077. No abstract available.
- Background: PubMed 34217425Meyer NJ, Gattinoni L, Calfee CS. Acute respiratory distress syndrome. Lancet. 2021 Aug 14;398(10300):622-637. doi: 10.1016/S0140-6736(21)00439-6. Epub 2021 Jul 1.
- Background: PubMed 27786562Yoshida T, Fujino Y, Amato MB, Kavanagh BP. Fifty Years of Research in ARDS. Spontaneous Breathing during Mechanical Ventilation. Risks, Mechanisms, and Management. Am J Respir Crit Care Med. 2017 Apr 15;195(8):985-992. doi: 10.1164/rccm.201604-0748CP.
- Background: PubMed 34271958Pelosi P, Ball L, Barbas CSV, Bellomo R, Burns KEA, Einav S, Gattinoni L, Laffey JG, Marini JJ, Myatra SN, Schultz MJ, Teboul JL, Rocco PRM. Personalized mechanical ventilation in acute respiratory distress syndrome. Crit Care. 2021 Jul 16;25(1):250. doi: 10.1186/s13054-021-03686-3.
- Background: PubMed 28459336Fan E, Del Sorbo L, Goligher EC, Hodgson CL, Munshi L, Walkey AJ, Adhikari NKJ, Amato MBP, Branson R, Brower RG, Ferguson ND, Gajic O, Gattinoni L, Hess D, Mancebo J, Meade MO, McAuley DF, Pesenti A, Ranieri VM, Rubenfeld GD, Rubin E, Seckel M, Slutsky AS, Talmor D, Thompson BT, Wunsch H, Uleryk E, Brozek J, Brochard LJ; American Thoracic Society, European Society of Intensive Care Medicine, and Society of Critical Care Medicine. An Official American Thoracic Society/European Society of Intensive Care Medicine/Society of Critical Care Medicine Clinical Practice Guideline: Mechanical Ventilation in Adult Patients with Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2017 May 1;195(9):1253-1263. doi: 10.1164/rccm.201703-0548ST.
- Background: PubMed 15691390Hess DR. Ventilator waveforms and the physiology of pressure support ventilation. Respir Care. 2005 Feb;50(2):166-86; discussion 183-6.
- Background: PubMed 20083921Spahija J, de Marchie M, Albert M, Bellemare P, Delisle S, Beck J, Sinderby C. Patient-ventilator interaction during pressure support ventilation and neurally adjusted ventilatory assist. Crit Care Med. 2010 Feb;38(2):518-26. doi: 10.1097/CCM.0b013e3181cb0d7b.
- Background: PubMed 8339649MacIntyre NR. Clinically available new strategies for mechanical ventilatory support. Chest. 1993 Aug;104(2):560-5. doi: 10.1378/chest.104.2.560. No abstract available.
- Background: PubMed 8636518Nava S, Bruschi C, Rubini F, Palo A, Iotti G, Braschi A. Respiratory response and inspiratory effort during pressure support ventilation in COPD patients. Intensive Care Med. 1995 Nov;21(11):871-9. doi: 10.1007/BF01712327.
- Background: PubMed 9196100Leung P, Jubran A, Tobin MJ. Comparison of assisted ventilator modes on triggering, patient effort, and dyspnea. Am J Respir Crit Care Med. 1997 Jun;155(6):1940-8. doi: 10.1164/ajrccm.155.6.9196100.
- Background: PubMed 10846029Yamada Y, Du HL. Analysis of the mechanisms of expiratory asynchrony in pressure support ventilation: a mathematical approach. J Appl Physiol (1985). 2000 Jun;88(6):2143-50. doi: 10.1152/jappl.2000.88.6.2143.
- Background: PubMed 11133620Tokioka H, Tanaka T, Ishizu T, Fukushima T, Iwaki T, Nakamura Y, Kosogabe Y. The effect of breath termination criterion on breathing patterns and the work of breathing during pressure support ventilation. Anesth Analg. 2001 Jan;92(1):161-5. doi: 10.1097/00000539-200101000-00031.
- Individual participant dataSharing planned: No. According to the International Council for Harmonisation of Technical Requirements (ICH) guidelines for the Good Clinical Practice (GCP), the monitoring team must check the Case Report Form (CRF) entries against source documents. The personnel bound by professional secret, must maintain the confidentiality of all personal identity or personal medical information. The confidentiality of records that could identify subjects should be protected, only initials of the name and the first name will be registered with a inclusion coded number for the study (no name nor address nor identifying data). Paper-based CRF will be designed by the PI. A unique code will be assigned to each participant in order to de-identify the data. It is the Investigator's responsibility to ensure the accuracy of all data entered and recorded in the CRFs. The database will be password protected and stored on a password-protected Personal Computer in a research office in the critical care department.
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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.
Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico
Milan, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neural Pressure Support and Pressure Support Ventilation in people with Acute Respiratory Failure, run by Policlinico Hospital 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 6 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 4 Jan 2023. 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Work Of Breathing (WOB) (time frame: 30 minutes ventilatory traces recording). 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 NCT05566652, which also lists 21 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 Jan 2023.