Mechanical Ventilation ComplicationDPNAVANCT03719365
Driving Pressure Variation: NAVA vs PSV
A study testing NAVAPSV in people with Mechanical Ventilation Complication and Ventilator-Induced Lung Injury, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
Trial summary
Assisted ventilation represents, nowadays, the preferred ventilation mode in clinical practice.It has been shown that assisted ventilation modes improve ventilation/perfusion matching, descrease risk of Ventilator induced lung injury and muscle atrophy and have less influence on haemodynamic function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication, Ventilator-Induced Lung Injury
- What is being tested?
- NAVAPSV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2018to 1 Nov 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
- Age >18 years
- Every patients undergoing partial assisted mechanical ventilation
Who cannot join
- Gastro-esophageal surgery in the previous 12 months;
- Gastro-esophageal bleeding in the previous 30 days;
- Esophageal varices history;
- Maxillo-facial surgery or trauma;
- Haemodinamic instability despite adequate fluid infusion (i.e. need for continuous infusion epinephrine or vasopressin or dopamine at a dose greater than 5 mcg/kg/min to obtain systolic pressure > 90 mmHg);
- Body temperature > 38° C during the study screening;
- Coagulation disorders (INR > 1.5, aPTT > 44 sec);
- Vt < 8 ml/kg with minimum inspiratory effort of 8 cmH2O;
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
A.O.U Maggiore della Carità
Novara, 28100
Gianmaria Cammarota, MD,PhD, 003903213733406, gmcamma@gmail.com
About this study
Official title: Driving Pressure Variation During Proportional Assisted Ventilation: Comparison Between NAVA and PSV
Assisted ventilation represents, nowadays, the preferred ventilation mode in clinical practice.It has been shown that assisted ventilation modes improve ventilation/perfusion matching, descrease risk of Ventilator induced lung injury and muscle atrophy and have less influence on haemodynamic function.
However, PSV (Pressure Support Ventilation) is not free from complications: it may worsen or cause lung injuries by increasing alveolar and intrathoracic negative pressure and by loosing control on Tidal Volume (Vt). Indeed, it has been demonstrated that Vt is the main factor related to VILI.
Read more
It has been shown that lower Vt and higher PEEP can improve clinical outcome only if associated with a simultaneous reduction in Driving Pressure. Increase in Driving Pressure resulted strongly associated with negative outcomes, especially if higher than 15 cm H2O.
PSV is currently the most used assisted ventilation mode. NAVA (Neurally Adjusted Ventilatory Assist) is a ventilation mode in which the diaphragmatic electrical activity (EAdi) is used as a trigger to start a mechanical breath, applying positive pressure during patient's inspiration. Diaphragmatic electrical activity (EAdi) can be detected by a particular nasogastric tube (EAdi catheter). EAdi is the currently available signal closest to the neural breathing centers, which can estimate the patient's respiratory drive, if phrenic nerves are not damaged. It has been demonstrated that NAVA ventilation can reduce the incidence of patient-ventilator asynchronies, because the delivery of the support and the cycling between inspiration and expiration are completely controlled by the patient.
However, although PSV and NAVA have been widely compared in many investigations, up to now there are no studies about driving pressure variation during these two modalities of mechanical assisted ventilation. The aim of this study is to measure changes in driving pressure at different levels of ventilatory assistance in PSV and NAVA ventilation modes.
Secondary end points are respiratory mechanics indices and patient/ventilator related asynchrony evaluation and comparison.
Read the detailed description
Any patient who is already on an assisted mode of ventilation and displays triggering efforts will be enrolled in the study and will be submitted to 3 ventilation trials, in PSV and NAVA ventilation modes; each trial will last 20 minutes. Every trial will be performed in a randomized order, based on random computer generated sequences.
During the first trial, PSV will be set in order to obtain a Vt between 6 and 8 ml/kg;this support level will be defined as PSV100. Subsequently, the corresponding NAVA level (NAVA 100) will be determined using a dedicated ventilator function (NAVA Preview) which is able to estimate NAVA level in order to deliver an equivalent inspiratory peak pressure (Paw peak) compared to that obtained during PSV mode. Afterwards, pressure support level of assistance of PSV100 and NAVA100 will be firstly increased (PSV150 and NAVA150) during the second trial and then decreased during the third trial (PSV50 and NAVA150) by 50% from basal value.
During the study period, PEEP and FiO2 will be kept equal to the values in use before patient enrollment. End-inspiration and end-expiration pauses will be performed at the end of each trial by pressing the dedicated button on the ventilator control panel. Airway pressure and flow will be recorded.
Patients, as usual, clinical practice, will be sedated at different levels and this could compromise their content of consciousness.
At the beginning of each trial, an endotracheal tube suction will be done. Last 5 minutes of each trial will be recorded and stored in a computer for subsequent statistical analysis. Respiratory mechanical indices (airway pressure, tidal volume, flow) and electric diaphragmatic activity will be recorded by a dedicated software called NAVA- tracker. At the end of each trial an arterial blood gas analysis (ABGs) will be performed to evaluate PaCO2, PH and blood oxygenation (PaO2). at the end of each trial, an ultrasound evaluation of diaphragm will be performed.
- Being tested
- NAVAPSV
- Keywords
- PSV, NAVA, Driving Pressure, Mechanical Assisted Ventilation
- Medical subject headings
- Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAVAPSVDevice
During the first trial, PSV will be set in order to obtain a Vt between 6 and 8 ml/kg; this support level will be defined as PSV100. Subsequently, the corresponding NAVA level (NAVA 100) will be determined using a dedicated ventilator function (NAVA Preview) which is able to estimate NAVA level in order to deliver an equivalent inspiratory peak pressure (Paw peak) compared to that obtained during PSV mode. Afterwards, PSV100 and NAVA100 will be first increased (PSV150 and NAVA150) during the second trial and then decreased during the third trial (PSV50 and NAVA150) by 50% from basal value. During the study period, PEEP and FiO2 will be kept equal to the values in use before patient enrollment.
| Study group | Role | What they receive |
|---|---|---|
| NAVAPSV | Experimental | Each patient enrolled in the study will be submitted to 3 ventilation trials during PSV and NAVA ventilation modes, assigned in a randomized order. Receives: Device: NAVAPSV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Driving pressure in PSV and NAVA
Driving Pressure measurements in in PSV and NAVA (cmH2O)
Measured: At the end of every 20 minutes lasting ventilation trial.
Secondary outcomes (4)
Respiratory mechanical indices variation
electrical diaphragmatic activity (mcvolts)
Measured: At the end of every 20 minutes lasting ventilation trial.
Patient/ventilator interaction
asynchrony index (normal value < 10%; pathological value > 10%)
Measured: At the end of every 20 minutes lasting ventilation trial.
Patient/ventilator interaction
time of synchrony (msec)
Measured: At the end of every 20 minutes lasting ventilation trial.
diaphragm ultrasound
evaluation of diaphragm performance at each trial
Measured: At the end of every 20 minutes lasting ventilation trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start1 Nov 2018
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilation ComplicationStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Randomized, interventional, prospective study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianmaria Cammarota, Azienda Ospedaliero Universitaria Maggiore della Carita
- Investigators
- Gianmaria Cammarota, MD, PhD, Principal investigator, AOU Maggiore della Carità
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719365
- Sponsor's protocol ID
- CE 110/18
- Acronym
- DPNAVA
- Status last verified
- Apr 2019
- First submitted
- 19 Oct 2018
- Last updated
- 12 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Putensen C, Zech S, Wrigge H, Zinserling J, Stuber F, Von Spiegel T, Mutz N. Long-term effects of spontaneous breathing during ventilatory support in patients with acute lung injury. Am J Respir Crit Care Med. 2001 Jul 1;164(1):43-9. doi: 10.1164/ajrccm.164.1.2001078.
PubMed 11435237Putensen C, Mutz NJ, Putensen-Himmer G, Zinserling J. Spontaneous breathing during ventilatory support improves ventilation-perfusion distributions in patients with acute respiratory distress syndrome. Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 1):1241-8. doi: 10.1164/ajrccm.159.4.9806077.
PubMed 10194172Grasso F, Engelberts D, Helm E, Frndova H, Jarvis S, Talakoub O, McKerlie C, Babyn P, Post M, Kavanagh BP. Negative-pressure ventilation: better oxygenation and less lung injury. Am J Respir Crit Care Med. 2008 Feb 15;177(4):412-8. doi: 10.1164/rccm.200707-1004OC. Epub 2007 Dec 13.
PubMed 18079496Xia J, Zhang H, Sun B, Yang R, He H, Zhan Q. Spontaneous breathing with biphasic positive airway pressure attenuates lung injury in hydrochloric acid-induced acute respiratory distress syndrome. Anesthesiology. 2014 Jun;120(6):1441-9. doi: 10.1097/ALN.0000000000000259.
PubMed 24722174Futier E, Constantin JM, Combaret L, Mosoni L, Roszyk L, Sapin V, Attaix D, Jung B, Jaber S, Bazin JE. Pressure support ventilation attenuates ventilator-induced protein modifications in the diaphragm. Crit Care. 2008;12(5):R116. doi: 10.1186/cc7010. Epub 2008 Sep 11.
PubMed 18786263Yoshida T, Uchiyama A, Matsuura N, Mashimo T, Fujino Y. Spontaneous breathing during lung-protective ventilation in an experimental acute lung injury model: high transpulmonary pressure associated with strong spontaneous breathing effort may worsen lung injury. Crit Care Med. 2012 May;40(5):1578-85. doi: 10.1097/CCM.0b013e3182451c40.
PubMed 22430241Yoshida T, Torsani V, Gomes S, De Santis RR, Beraldo MA, Costa EL, Tucci MR, Zin WA, Kavanagh BP, Amato MB. Spontaneous effort causes occult pendelluft during mechanical ventilation. Am J Respir Crit Care Med. 2013 Dec 15;188(12):1420-7. doi: 10.1164/rccm.201303-0539OC.
PubMed 24199628Yoshida T, Uchiyama A, Matsuura N, Mashimo T, Fujino Y. The comparison of spontaneous breathing and muscle paralysis in two different severities of experimental lung injury. Crit Care Med. 2013 Feb;41(2):536-45. doi: 10.1097/CCM.0b013e3182711972.
PubMed 23263584Amato MB, Barbas CS, Medeiros DM, Magaldi RB, Schettino GP, Lorenzi-Filho G, Kairalla RA, Deheinzelin D, Munoz C, Oliveira R, Takagaki TY, Carvalho CR. Effect of a protective-ventilation strategy on mortality in the acute respiratory distress syndrome. N Engl J Med. 1998 Feb 5;338(6):347-54. doi: 10.1056/NEJM199802053380602.
PubMed 9449727Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
PubMed 10793162Malhotra A. Low-tidal-volume ventilation in the acute respiratory distress syndrome. N Engl J Med. 2007 Sep 13;357(11):1113-20. doi: 10.1056/NEJMct074213.
PubMed 17855672Mascia L, Pasero D, Slutsky AS, Arguis MJ, Berardino M, Grasso S, Munari M, Boifava S, Cornara G, Della Corte F, Vivaldi N, Malacarne P, Del Gaudio P, Livigni S, Zavala E, Filippini C, Martin EL, Donadio PP, Mastromauro I, Ranieri VM. Effect of a lung protective strategy for organ donors on eligibility and availability of lungs for transplantation: a randomized controlled trial. JAMA. 2010 Dec 15;304(23):2620-7. doi: 10.1001/jama.2010.1796.
PubMed 21156950Serpa Neto A, Cardoso SO, Manetta JA, Pereira VG, Esposito DC, Pasqualucci Mde O, Damasceno MC, Schultz MJ. Association between use of lung-protective ventilation with lower tidal volumes and clinical outcomes among patients without acute respiratory distress syndrome: a meta-analysis. JAMA. 2012 Oct 24;308(16):1651-9. doi: 10.1001/jama.2012.13730.
PubMed 23093163Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.
PubMed 23902482Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639.
PubMed 25693014
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Driving Pressure Variation During Proportional Assisted Ventilation: Comparison Between NAVA and PSV
- ClinicalTrials.gov ID
- NCT03719365
- Acronym / sponsor ID
- DPNAVA / CE 110/18
- Keywords
- PSV, NAVA, Driving Pressure, Mechanical Assisted Ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 25 Oct 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.
Assisted ventilation represents, nowadays, the preferred ventilation mode in clinical practice.It has been shown that assisted ventilation modes improve ventilation/perfusion matching, descrease risk of Ventilator induced lung injury and muscle atrophy and have less influence on haemodynamic function.
However, PSV (Pressure Support Ventilation) is not free from complications: it may worsen or cause lung injuries by increasing alveolar and intrathoracic negative pressure and by loosing control on Tidal Volume (Vt). Indeed, it has been demonstrated that Vt is the main factor related to VILI.
It has been shown that lower Vt and higher PEEP can improve clinical outcome only if associated with a simultaneous reduction in Driving Pressure. Increase in Driving Pressure resulted strongly associated with negative outcomes, especially if higher than 15 cm H2O.
PSV is currently the most used assisted ventilation mode. NAVA (Neurally Adjusted Ventilatory Assist) is a ventilation mode in which the diaphragmatic electrical activity (EAdi) is used as a trigger to start a mechanical breath, applying positive pressure during patient's inspiration. Diaphragmatic electrical activity (EAdi) can be detected by a particular nasogastric tube (EAdi catheter). EAdi is the currently available signal closest to the neural breathing centers, which can estimate the patient's respiratory drive, if phrenic nerves are not damaged. It has been demonstrated that NAVA ventilation can reduce the incidence of patient-ventilator asynchronies, because the delivery of the support and the cycling between inspiration and expiration are completely controlled by the patient.
However, although PSV and NAVA have been widely compared in many investigations, up to now there are no studies about driving pressure variation during these two modalities of mechanical assisted ventilation. The aim of this study is to measure changes in driving pressure at different levels of ventilatory assistance in PSV and NAVA ventilation modes.
Secondary end points are respiratory mechanics indices and patient/ventilator related asynchrony evaluation and comparison.
Detailed description
Any patient who is already on an assisted mode of ventilation and displays triggering efforts will be enrolled in the study and will be submitted to 3 ventilation trials, in PSV and NAVA ventilation modes; each trial will last 20 minutes. Every trial will be performed in a randomized order, based on random computer generated sequences.
During the first trial, PSV will be set in order to obtain a Vt between 6 and 8 ml/kg;this support level will be defined as PSV100. Subsequently, the corresponding NAVA level (NAVA 100) will be determined using a dedicated ventilator function (NAVA Preview) which is able to estimate NAVA level in order to deliver an equivalent inspiratory peak pressure (Paw peak) compared to that obtained during PSV mode. Afterwards, pressure support level of assistance of PSV100 and NAVA100 will be firstly increased (PSV150 and NAVA150) during the second trial and then decreased during the third trial (PSV50 and NAVA150) by 50% from basal value.
During the study period, PEEP and FiO2 will be kept equal to the values in use before patient enrollment. End-inspiration and end-expiration pauses will be performed at the end of each trial by pressing the dedicated button on the ventilator control panel. Airway pressure and flow will be recorded.
Patients, as usual, clinical practice, will be sedated at different levels and this could compromise their content of consciousness.
At the beginning of each trial, an endotracheal tube suction will be done. Last 5 minutes of each trial will be recorded and stored in a computer for subsequent statistical analysis. Respiratory mechanical indices (airway pressure, tidal volume, flow) and electric diaphragmatic activity will be recorded by a dedicated software called NAVA- tracker. At the end of each trial an arterial blood gas analysis (ABGs) will be performed to evaluate PaCO2, PH and blood oxygenation (PaO2). at the end of each trial, an ultrasound evaluation of diaphragm will be performed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Randomized, interventional, prospective study
| Arm | Type | Receives |
|---|---|---|
| NAVAPSV | Experimental | Device: NAVAPSVEach patient enrolled in the study will be submitted to 3 ventilation trials during PSV and NAVA ventilation modes, assigned in a randomized order. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >18 years
- Every patients undergoing partial assisted mechanical ventilation
Key exclusion criteria (8 listed)
- Gastro-esophageal surgery in the previous 12 months;
- Gastro-esophageal bleeding in the previous 30 days;
- Esophageal varices history;
- Maxillo-facial surgery or trauma;
- Haemodinamic instability despite adequate fluid infusion (i.e. need for continuous infusion epinephrine or vasopressin or dopamine at a dose greater than 5 mcg/kg/min to obtain systolic pressure > 90 mmHg);
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 |
|---|---|---|
| NAVAPSVDuring the first trial, PSV will be set in order to obtain a Vt between 6 and 8 ml/kg; this support level will be defined as PSV100. Subsequently, the corresponding NAVA level (NAVA 100) will be determined using a dedicated ventilator function (NAVA Preview) which is able to estimate NAVA level in order to deliver an equivalent inspiratory peak pressure (Paw peak) compared to that obtained during PSV mode. Afterwards, PSV100 and NAVA100 will be first increased (PSV150 and NAVA150) during the second trial and then decreased during the third trial (PSV50 and NAVA150) by 50% from basal value. During the study period, PEEP and FiO2 will be kept equal to the values in use before patient enrollment. | Device | NAVAPSV |
Primary outcome
Driving pressure in PSV and NAVA
Time frame: At the end of every 20 minutes lasting ventilation trial.
Driving Pressure measurements in in PSV and NAVA (cmH2O)
4 secondary outcomes
Respiratory mechanical indices variation
Time frame: At the end of every 20 minutes lasting ventilation trial.
Patient/ventilator interaction
Time frame: At the end of every 20 minutes lasting ventilation trial.
Patient/ventilator interaction
Time frame: At the end of every 20 minutes lasting ventilation trial.
diaphragm ultrasound
Time frame: At the end of every 20 minutes lasting ventilation trial.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- Background: PubMed 11435237Putensen C, Zech S, Wrigge H, Zinserling J, Stuber F, Von Spiegel T, Mutz N. Long-term effects of spontaneous breathing during ventilatory support in patients with acute lung injury. Am J Respir Crit Care Med. 2001 Jul 1;164(1):43-9. doi: 10.1164/ajrccm.164.1.2001078.
- Background: PubMed 10194172Putensen C, Mutz NJ, Putensen-Himmer G, Zinserling J. Spontaneous breathing during ventilatory support improves ventilation-perfusion distributions in patients with acute respiratory distress syndrome. Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 1):1241-8. doi: 10.1164/ajrccm.159.4.9806077.
- Background: PubMed 18079496Grasso F, Engelberts D, Helm E, Frndova H, Jarvis S, Talakoub O, McKerlie C, Babyn P, Post M, Kavanagh BP. Negative-pressure ventilation: better oxygenation and less lung injury. Am J Respir Crit Care Med. 2008 Feb 15;177(4):412-8. doi: 10.1164/rccm.200707-1004OC. Epub 2007 Dec 13.
- Background: PubMed 24722174Xia J, Zhang H, Sun B, Yang R, He H, Zhan Q. Spontaneous breathing with biphasic positive airway pressure attenuates lung injury in hydrochloric acid-induced acute respiratory distress syndrome. Anesthesiology. 2014 Jun;120(6):1441-9. doi: 10.1097/ALN.0000000000000259.
- Background: PubMed 18786263Futier E, Constantin JM, Combaret L, Mosoni L, Roszyk L, Sapin V, Attaix D, Jung B, Jaber S, Bazin JE. Pressure support ventilation attenuates ventilator-induced protein modifications in the diaphragm. Crit Care. 2008;12(5):R116. doi: 10.1186/cc7010. Epub 2008 Sep 11.
- Background: PubMed 22430241Yoshida T, Uchiyama A, Matsuura N, Mashimo T, Fujino Y. Spontaneous breathing during lung-protective ventilation in an experimental acute lung injury model: high transpulmonary pressure associated with strong spontaneous breathing effort may worsen lung injury. Crit Care Med. 2012 May;40(5):1578-85. doi: 10.1097/CCM.0b013e3182451c40.
- Background: PubMed 24199628Yoshida T, Torsani V, Gomes S, De Santis RR, Beraldo MA, Costa EL, Tucci MR, Zin WA, Kavanagh BP, Amato MB. Spontaneous effort causes occult pendelluft during mechanical ventilation. Am J Respir Crit Care Med. 2013 Dec 15;188(12):1420-7. doi: 10.1164/rccm.201303-0539OC.
- Background: PubMed 23263584Yoshida T, Uchiyama A, Matsuura N, Mashimo T, Fujino Y. The comparison of spontaneous breathing and muscle paralysis in two different severities of experimental lung injury. Crit Care Med. 2013 Feb;41(2):536-45. doi: 10.1097/CCM.0b013e3182711972.
- Background: PubMed 9449727Amato MB, Barbas CS, Medeiros DM, Magaldi RB, Schettino GP, Lorenzi-Filho G, Kairalla RA, Deheinzelin D, Munoz C, Oliveira R, Takagaki TY, Carvalho CR. Effect of a protective-ventilation strategy on mortality in the acute respiratory distress syndrome. N Engl J Med. 1998 Feb 5;338(6):347-54. doi: 10.1056/NEJM199802053380602.
- Background: PubMed 10793162Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
- Background: PubMed 17855672Malhotra A. Low-tidal-volume ventilation in the acute respiratory distress syndrome. N Engl J Med. 2007 Sep 13;357(11):1113-20. doi: 10.1056/NEJMct074213.
- Background: PubMed 21156950Mascia L, Pasero D, Slutsky AS, Arguis MJ, Berardino M, Grasso S, Munari M, Boifava S, Cornara G, Della Corte F, Vivaldi N, Malacarne P, Del Gaudio P, Livigni S, Zavala E, Filippini C, Martin EL, Donadio PP, Mastromauro I, Ranieri VM. Effect of a lung protective strategy for organ donors on eligibility and availability of lungs for transplantation: a randomized controlled trial. JAMA. 2010 Dec 15;304(23):2620-7. doi: 10.1001/jama.2010.1796.
- Individual participant dataSharing planned: Undecided
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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.
Gianmaria Cammarota, MD, PhD principal investigator
AOU Maggiore della Carità
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAVAPSV in people with Mechanical Ventilation Complication and Ventilator-Induced Lung Injury, run by Azienda Ospedaliero Universitaria Maggiore della Carita 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 2 inclusion and 8 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 12 Apr 2019. 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 Gianmaria Cammarota, MD, PhD (00393392669420, gmcamma@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Driving pressure in PSV and NAVA (time frame: At the end of every 20 minutes lasting ventilation 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 NCT03719365, which also lists 24 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 12 Apr 2019; AzTrials last refreshed its copy on 26 Oct 2026.