Respiratory FailureNCT03271671
Pressure Support Ventilation (PSV) Versus Neurally Adjusted Ventilator Assist (NAVA) During Acute Respiratory Failure (ARF)
A study testing NAVA during Non invasive ventilation and PSV during Non invasive ventilation in people with Respiratory Failure, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Acute respiratory failure (ARF) is a life-threatening emergency which occurs due to impaired gas exchange. In the US, the number of hospitalisations owing to acute respiratory failure was 1,917,910 in the year 2009.(1) The incidence of ARF requiring hospitalization was 137.1 per 100,000 population.(2) In ARF due to… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- NAVA during Non invasive ventilation and PSV during Non invasive ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 1 Oct 2017to 31 Mar 2019
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Respiratory rate >30 per minute
- Arterial blood gas analysis showing a PaCO2 >45 mmHg and pH <7.35
- PaO2/FiO2 ratio < 300
- Use of accessory muscles of respiration or paradoxical respiration
Who cannot join
- Age <18 years or >75 years
- Pregnancy
- PaO2/FiO2 ratio ≤100
- Hypotension (systolic blood pressure <90 mmHg)
- Severe impairment of consciousness (Glasgow coma scale score <8)
- Inability to clear respiratory secretions (Airway care score [ACS] ≥12)(27)
Show all 16Show fewer
- Abnormalities that preclude proper fit of the NIV interface (agitated or uncooperative patient, facial trauma or burns, facial surgery, or facial anatomical abnormality)
- Subjects who have an artificial airway like tracheostomy tube or T-tube
- Contraindications for insertion of naso-/orogastric feeding tube (facial/nasal trauma, recent upper airway surgery, esophageal surgery, esophageal varices, upper gastrointestinal bleeding)
- More than two organ failures
- Unwillingness to undergo placement of nasogastric catheter
- Known phrenic nerve lesions
- Suspected diaphragmatic weakness
- Patient already on home NIV therapy for chronic respiratory failure
- Application of NIV for more than one hour for the current illness
- Failure to provide informed consent
Trial locations and contacts
1 site in 1 country.
India1 site
Respiratory ICU, Post Graduate Institue of Medical Education and Research
Chandigarh, 160012
About this study
Official title: A Randomized Controlled Trial Comparing Non-invasive Ventilation (NIV) With Pressure Support Ventilation (PSV) Versus Neurally Adjusted Ventilator Assist (NAVA) During Acute Respiratory Failure (ARF)
Acute respiratory failure (ARF) is a life-threatening emergency which occurs due to impaired gas exchange. In the US, the number of hospitalisations owing to acute respiratory failure was 1,917,910 in the year 2009.(1) The incidence of ARF requiring hospitalization was 137.1 per 100,000 population.(2) In ARF due to chronic obstructive pulmonary disease (COPD) and cardiogenic pulmonary edema, non-invasive ventilation (NIV) has been shown to be beneficial. NIV also has several advantages over invasive mechanical ventilation. These include, avoidance of endotracheal intubation and its attendant complications like airway injury, nosocomial infections, and possibly shorter duration of intensive care unit (ICU) stay.(3, 4) The success of NIV depends on several factors like the etiology of the respiratory failure, careful monitoring by the treating physician, and also adequate cooperation of patient. Better synchrony of the patient's spontaneous breaths with the ventilator-delivered breaths may lead to better patient cooperation and thereby, better clinical outcomes. Patient-ventilator asynchrony (PVA) leads to dyspnea, increased work of breathing, and prolonged duration of mechanical ventilation.(5) Pressure support ventilation (PSV) is one of the commonest mode used during NIV. In a prospective multicenter observational study, severe asynchrony (defined as an asynchrony index of >10 %) was seen in 43% of patients of patients with ARF ventilated by NIV with the conventional PSV mode.(6) Neurally adjusted ventilator assist (NAVA) is new mode of ventilation which utilizes the electrical activity of the diaphragm to deliver the breath.(7) During NAVA, breath is delivered when the patient's diaphragm starts contracting. Further, the amount of pressure support given during the breath is proportional to the strength of the electrical signal from the diaphragm. Finally, NAVA also terminates the breath when the electrical activity of the diaphragm wanes. NAVA has been shown to avoid over-assistance, decrease intrinsic positive end-expiratory pressure (PEEP), and minimize wasted efforts.(8) Hence, NAVA may play a major role in improving patient-ventilator synchrony.
In a pooled analysis of studies comparing NAVA with PSV during NIV, it was shown that the use of NAVA significantly improved patient-ventilator synchrony.(9) However, so far, no clinical trial has demonstrated that this improvement in synchrony translates into better clinical outcomes. In this randomized controlled clinical trial, we intend to compare the rates of NIV failure and mortality between NAVA and PSV in subjects with acute respiratory failure managed with NIV.
Read the detailed description
NIV is mode of ventilation wherein positive pressure ventilation is delivered by non-invasive interface like nasal mask, face mask, nasal plugs or helmet avoiding invasive interface by endotracheal intubation or by tracheostomy. In 1980s NIV by mask was used with success in patients of obstructive sleep apnea and later on in neuromuscular respiratory failure. Use of NIV has increased subsequently over next 20 years with overall first line NIV being used upto 23% (10) NIV is definitely useful as first line of management in COPD exacerbation, cardiogenic pulmonary edema, post extubation respiratory failure and is also worth trial with conflicting data in cases of acute hypoxemic respiratory failure due to pneumonia, ARDS.
In cases of acute exacerbation of COPD, NIV improves clinical outcomes.(11-13) In a metaanalysis by Ram FS et al which included 14 RCT and 758 patients which showed decreased mortality(11 vs 21%), intubation rate(16 vs 33%) and treatment failure(20 vs 42%)(12). Similarly, there is high quality evidence supporting use in cardiogenic pulmonary edema showing to improve respiratory parameters and decrease intubation rates (14-17). A meta-analysis of 32 studies including 2916 patients in 2013 by Vital FM et al showed that NIV reduces in hospital mortality compared to standard medical care(RR 0.66, 95% CI 0.48 - 0.89)(14) NAVA as mode of ventilation was developed after initial landmark study "neural control of mechanical ventilation in respiratory failure" was published in 1998 by Sinderby(7). It was later on introduced on the servo-i ventilator in 2007. NAVA is a kind of pressure assist ventilation using electrical activity of diaphragm and thus the neural output to initiate the breath, regulate the assist level and cycle off the breath.
In study by Piquilloud et al of 13 patients which compared NAVA with PSV during NIV there was significant difference in asynchronies. Trigger delay (Td) was reduced with NAVA to 35 ms (IQR 31-53 ms) versus 181 ms (122 - 208 ms). Also, there were no premature or delayed cycling, ineffective efforts in the NAVA group. Asynchrony index (AI) with NAVA was 4.9% (2.2 - 10.5%) compared to 15.8% (5.5 - 49.6%) with PSV (20)In a recent meta-analysis comparing PSV with NAVA during NIV by Inderpaul et al which included 9 studies with 96 subjects including both adult and paediatric patients showed that asynchronies were more in PSV than in NAVA in both adult and paediatric studies. The overall pooled mean difference of asynchrony index was 28.02(95% CI, 11.61 - 44.42). also the risk of severe asynchrony was 3.4 % times higher in PSV compared to NAVA group.(9) NAVA mode of ventilation in previous studies has shown to decrease asynchrony with ventilator, mainly reducing ineffective efforts, cycling delays. Ineffective efforts may occur due to presence of intrinsic PEEP which in turn is more common during prolonged insufflations and at high levels of assist. Ineffective efforts may also occur with weak inspiratory efforts which may occur during states of high respiratory drive. NAVA uses electrical activity of diaphragm to trigger a breath and there is marked difference in improving synchrony with studies reporting no wasted efforts when compared to PSV mode. In a study by Vignaux et al showed that during conventional NIV, 40 % of the patients experience asynchrony and the rate of asynchrony correlated with leakage(6). In NAVA mode of ventilation assistance is delivered based upon the neural trigger and hence is not affected by leaks.
In a pooled analysis of studies comparing NAVA with PSV during NIV, it was shown that the use of NAVA significantly improved patient-ventilator synchrony.(9) However, so far, no clinical trial has demonstrated that this improvement in synchrony translates into better clinical outcomes. In this randomized controlled clinical trial, we intend to compare the rates of NIV failure and mortality between NAVA and PSV in subjects with acute respiratory failure managed with NIV.
- Conditions
- Respiratory Failure
- Being tested
- NAVA during Non invasive ventilation, PSV during Non invasive ventilation
- Keywords
- neurally adjusted ventilator assist, Pressure support ventilation, non invasive ventilation, niv
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAVA during Non invasive ventilationOther
NIV during respiratory failure
PSV during Non invasive ventilationOther
PSV during respiratory failure
| Study group | Role | What they receive |
|---|---|---|
| PSV | Active comparator | Pressure support ventilation Receives: Other: PSV during Non invasive ventilation |
| NAVA | Experimental | Neurally adjusted ventilator assist Receives: Other: NAVA during Non invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of NIV failures
NIV will be deemed to have failed if the patient gets intubated or is reinitiated on NIV within 48 hours of discontinuation of NIV
Measured: 28 days
28-day mortality
28-day mortality including ICU and hospital deaths will be assessed
Measured: 28 days
Secondary outcomes (6)
Time to successful weaning
Time to successful weaning will be defined as the duration between initiation of NIV and successful weaning from NIV.
Measured: 28 days
Time to NIV failure
Time to NIV failure will be calculated as the duration between initiation of NIV and the event which lead to NIV failure.
Measured: 28 days
Total duration of mechanical ventilation (both non-invasive and invasive)
Total duration of mechanical ventilation will be calculated as the total duration spent on NIV and IMV by the patient.
Measured: 28 days
Length of ICU and hospital stay
The length of ICU and hospital stay of the patient will also be assessed.
Measured: 28 days
Patient's level of comfort during NIV using VAS
The patient's level of comfort while undergoing NIV will be assessed using a similar VAS. These assessments will be made every day till day 5 or till the patient is weaned off NIV, whichever is earlier.
Measured: 28 days
Physician's level of comfort while using the assigned NIV strategy using VAS
The physician's level of comfort while using the two different modes of NIV will be assessed using a visual analogue scale (VAS). The assessment will be obtained from the treating physician at each shift.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start1 Oct 2017
- Primary completion15 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial comparing two modes of non invasive ventilation
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inderpaul singh, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Inderpaul S Sehgal, MD,DM, Principal investigator, PGIMER,Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271671
- Sponsor's protocol ID
- TRB2447/1/7/17
- Status last verified
- Apr 2019
- First submitted
- 1 Sep 2017
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Complete protocol and individual patient data after publication of results
Publications
Stefan MS, Shieh MS, Pekow PS, Rothberg MB, Steingrub JS, Lagu T, Lindenauer PK. Epidemiology and outcomes of acute respiratory failure in the United States, 2001 to 2009: a national survey. J Hosp Med. 2013 Feb;8(2):76-82. doi: 10.1002/jhm.2004. Epub 2013 Jan 18.
PubMed 23335231Behrendt CE. Acute respiratory failure in the United States: incidence and 31-day survival. Chest. 2000 Oct;118(4):1100-5. doi: 10.1378/chest.118.4.1100.
PubMed 11035684Peter JV, Moran JL, Phillips-Hughes J, Warn D. Noninvasive ventilation in acute respiratory failure--a meta-analysis update. Crit Care Med. 2002 Mar;30(3):555-62. doi: 10.1097/00003246-200203000-00010.
PubMed 11990914Girou E, Schortgen F, Delclaux C, Brun-Buisson C, Blot F, Lefort Y, Lemaire F, Brochard L. Association of noninvasive ventilation with nosocomial infections and survival in critically ill patients. JAMA. 2000 Nov 8;284(18):2361-7. doi: 10.1001/jama.284.18.2361.
PubMed 11066187Georgopoulos D, Prinianakis G, Kondili E. Bedside waveforms interpretation as a tool to identify patient-ventilator asynchronies. Intensive Care Med. 2006 Jan;32(1):34-47. doi: 10.1007/s00134-005-2828-5. Epub 2005 Nov 9.
PubMed 16283171Vignaux L, Vargas F, Roeseler J, Tassaux D, Thille AW, Kossowsky MP, Brochard L, Jolliet P. Patient-ventilator asynchrony during non-invasive ventilation for acute respiratory failure: a multicenter study. Intensive Care Med. 2009 May;35(5):840-6. doi: 10.1007/s00134-009-1416-5. Epub 2009 Jan 29.
PubMed 19183949Prasad KT, Gandra RR, Dhooria S, Muthu V, Aggarwal AN, Agarwal R, Sehgal IS. Comparing Noninvasive Ventilation Delivered Using Neurally-Adjusted Ventilatory Assist or Pressure Support in Acute Respiratory Failure. Respir Care. 2021 Feb;66(2):213-220. doi: 10.4187/respcare.07952. Epub 2020 Sep 1.
PubMed 32873750
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Non-invasive Ventilation (NIV) With Pressure Support Ventilation (PSV) Versus Neurally Adjusted Ventilator Assist (NAVA) During Acute Respiratory Failure (ARF)
- ClinicalTrials.gov ID
- NCT03271671
- Acronym / sponsor ID
- TRB2447/1/7/17
- Conditions
- Respiratory Failure
- Keywords
- neurally adjusted ventilator assist, Pressure support ventilation, non invasive ventilation, niv
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 5 Sep 2017 (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.
Acute respiratory failure (ARF) is a life-threatening emergency which occurs due to impaired gas exchange. In the US, the number of hospitalisations owing to acute respiratory failure was 1,917,910 in the year 2009.(1) The incidence of ARF requiring hospitalization was 137.1 per 100,000 population.(2) In ARF due to chronic obstructive pulmonary disease (COPD) and cardiogenic pulmonary edema, non-invasive ventilation (NIV) has been shown to be beneficial. NIV also has several advantages over invasive mechanical ventilation. These include, avoidance of endotracheal intubation and its attendant complications like airway injury, nosocomial infections, and possibly shorter duration of intensive care unit (ICU) stay.(3, 4) The success of NIV depends on several factors like the etiology of the respiratory failure, careful monitoring by the treating physician, and also adequate cooperation of patient. Better synchrony of the patient's spontaneous breaths with the ventilator-delivered breaths may lead to better patient cooperation and thereby, better clinical outcomes. Patient-ventilator asynchrony (PVA) leads to dyspnea, increased work of breathing, and prolonged duration of mechanical ventilation.(5) Pressure support ventilation (PSV) is one of the commonest mode used during NIV. In a prospective multicenter observational study, severe asynchrony (defined as an asynchrony index of >10 %) was seen in 43% of patients of patients with ARF ventilated by NIV with the conventional PSV mode.(6) Neurally adjusted ventilator assist (NAVA) is new mode of ventilation which utilizes the electrical activity of the diaphragm to deliver the breath.(7) During NAVA, breath is delivered when the patient's diaphragm starts contracting. Further, the amount of pressure support given during the breath is proportional to the strength of the electrical signal from the diaphragm. Finally, NAVA also terminates the breath when the electrical activity of the diaphragm wanes. NAVA has been shown to avoid over-assistance, decrease intrinsic positive end-expiratory pressure (PEEP), and minimize wasted efforts.(8) Hence, NAVA may play a major role in improving patient-ventilator synchrony.
In a pooled analysis of studies comparing NAVA with PSV during NIV, it was shown that the use of NAVA significantly improved patient-ventilator synchrony.(9) However, so far, no clinical trial has demonstrated that this improvement in synchrony translates into better clinical outcomes. In this randomized controlled clinical trial, we intend to compare the rates of NIV failure and mortality between NAVA and PSV in subjects with acute respiratory failure managed with NIV.
Detailed description
NIV is mode of ventilation wherein positive pressure ventilation is delivered by non-invasive interface like nasal mask, face mask, nasal plugs or helmet avoiding invasive interface by endotracheal intubation or by tracheostomy. In 1980s NIV by mask was used with success in patients of obstructive sleep apnea and later on in neuromuscular respiratory failure. Use of NIV has increased subsequently over next 20 years with overall first line NIV being used upto 23% (10) NIV is definitely useful as first line of management in COPD exacerbation, cardiogenic pulmonary edema, post extubation respiratory failure and is also worth trial with conflicting data in cases of acute hypoxemic respiratory failure due to pneumonia, ARDS.
In cases of acute exacerbation of COPD, NIV improves clinical outcomes.(11-13) In a metaanalysis by Ram FS et al which included 14 RCT and 758 patients which showed decreased mortality(11 vs 21%), intubation rate(16 vs 33%) and treatment failure(20 vs 42%)(12). Similarly, there is high quality evidence supporting use in cardiogenic pulmonary edema showing to improve respiratory parameters and decrease intubation rates (14-17). A meta-analysis of 32 studies including 2916 patients in 2013 by Vital FM et al showed that NIV reduces in hospital mortality compared to standard medical care(RR 0.66, 95% CI 0.48 - 0.89)(14) NAVA as mode of ventilation was developed after initial landmark study "neural control of mechanical ventilation in respiratory failure" was published in 1998 by Sinderby(7). It was later on introduced on the servo-i ventilator in 2007. NAVA is a kind of pressure assist ventilation using electrical activity of diaphragm and thus the neural output to initiate the breath, regulate the assist level and cycle off the breath.
In study by Piquilloud et al of 13 patients which compared NAVA with PSV during NIV there was significant difference in asynchronies. Trigger delay (Td) was reduced with NAVA to 35 ms (IQR 31-53 ms) versus 181 ms (122 - 208 ms). Also, there were no premature or delayed cycling, ineffective efforts in the NAVA group. Asynchrony index (AI) with NAVA was 4.9% (2.2 - 10.5%) compared to 15.8% (5.5 - 49.6%) with PSV (20)In a recent meta-analysis comparing PSV with NAVA during NIV by Inderpaul et al which included 9 studies with 96 subjects including both adult and paediatric patients showed that asynchronies were more in PSV than in NAVA in both adult and paediatric studies. The overall pooled mean difference of asynchrony index was 28.02(95% CI, 11.61 - 44.42). also the risk of severe asynchrony was 3.4 % times higher in PSV compared to NAVA group.(9) NAVA mode of ventilation in previous studies has shown to decrease asynchrony with ventilator, mainly reducing ineffective efforts, cycling delays. Ineffective efforts may occur due to presence of intrinsic PEEP which in turn is more common during prolonged insufflations and at high levels of assist. Ineffective efforts may also occur with weak inspiratory efforts which may occur during states of high respiratory drive. NAVA uses electrical activity of diaphragm to trigger a breath and there is marked difference in improving synchrony with studies reporting no wasted efforts when compared to PSV mode. In a study by Vignaux et al showed that during conventional NIV, 40 % of the patients experience asynchrony and the rate of asynchrony correlated with leakage(6). In NAVA mode of ventilation assistance is delivered based upon the neural trigger and hence is not affected by leaks.
In a pooled analysis of studies comparing NAVA with PSV during NIV, it was shown that the use of NAVA significantly improved patient-ventilator synchrony.(9) However, so far, no clinical trial has demonstrated that this improvement in synchrony translates into better clinical outcomes. In this randomized controlled clinical trial, we intend to compare the rates of NIV failure and mortality between NAVA and PSV in subjects with acute respiratory failure managed with NIV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial comparing two modes of non invasive ventilation
| Arm | Type | Receives |
|---|---|---|
| PSV | Active comparator | Other: PSV during Non invasive ventilationPressure support ventilation |
| NAVA | Experimental | Other: NAVA during Non invasive ventilationNeurally adjusted ventilator assist |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Respiratory rate >30 per minute
- Arterial blood gas analysis showing a PaCO2 >45 mmHg and pH <7.35
- PaO2/FiO2 ratio < 300
- Use of accessory muscles of respiration or paradoxical respiration
Key exclusion criteria (16 listed)
- Age <18 years or >75 years
- Pregnancy
- PaO2/FiO2 ratio ≤100
- Hypotension (systolic blood pressure <90 mmHg)
- Severe impairment of consciousness (Glasgow coma scale score <8)
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 |
|---|---|---|
| NAVA during Non invasive ventilationNIV during respiratory failure | Other | NAVA |
| PSV during Non invasive ventilationPSV during respiratory failure | Other | PSV |
Primary outcome
Rates of NIV failures
Time frame: 28 days
NIV will be deemed to have failed if the patient gets intubated or is reinitiated on NIV within 48 hours of discontinuation of NIV
28-day mortality
Time frame: 28 days
28-day mortality including ICU and hospital deaths will be assessed
6 secondary outcomes
Time to successful weaning
Time frame: 28 days
Time to NIV failure
Time frame: 28 days
Total duration of mechanical ventilation (both non-invasive and invasive)
Time frame: 28 days
Length of ICU and hospital stay
Time frame: 28 days
Patient's level of comfort during NIV using VAS
Time frame: 28 days
Physician's level of comfort while using the assigned NIV strategy using VAS
Time frame: 28 days
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 10 Apr 2019.
- Background: PubMed 23335231Stefan MS, Shieh MS, Pekow PS, Rothberg MB, Steingrub JS, Lagu T, Lindenauer PK. Epidemiology and outcomes of acute respiratory failure in the United States, 2001 to 2009: a national survey. J Hosp Med. 2013 Feb;8(2):76-82. doi: 10.1002/jhm.2004. Epub 2013 Jan 18.
- Background: PubMed 11035684Behrendt CE. Acute respiratory failure in the United States: incidence and 31-day survival. Chest. 2000 Oct;118(4):1100-5. doi: 10.1378/chest.118.4.1100.
- Background: PubMed 11990914Peter JV, Moran JL, Phillips-Hughes J, Warn D. Noninvasive ventilation in acute respiratory failure--a meta-analysis update. Crit Care Med. 2002 Mar;30(3):555-62. doi: 10.1097/00003246-200203000-00010.
- Background: PubMed 11066187Girou E, Schortgen F, Delclaux C, Brun-Buisson C, Blot F, Lefort Y, Lemaire F, Brochard L. Association of noninvasive ventilation with nosocomial infections and survival in critically ill patients. JAMA. 2000 Nov 8;284(18):2361-7. doi: 10.1001/jama.284.18.2361.
- Background: PubMed 16283171Georgopoulos D, Prinianakis G, Kondili E. Bedside waveforms interpretation as a tool to identify patient-ventilator asynchronies. Intensive Care Med. 2006 Jan;32(1):34-47. doi: 10.1007/s00134-005-2828-5. Epub 2005 Nov 9.
- Background: PubMed 19183949Vignaux L, Vargas F, Roeseler J, Tassaux D, Thille AW, Kossowsky MP, Brochard L, Jolliet P. Patient-ventilator asynchrony during non-invasive ventilation for acute respiratory failure: a multicenter study. Intensive Care Med. 2009 May;35(5):840-6. doi: 10.1007/s00134-009-1416-5. Epub 2009 Jan 29.
- Derived from this study: PubMed 32873750Prasad KT, Gandra RR, Dhooria S, Muthu V, Aggarwal AN, Agarwal R, Sehgal IS. Comparing Noninvasive Ventilation Delivered Using Neurally-Adjusted Ventilatory Assist or Pressure Support in Acute Respiratory Failure. Respir Care. 2021 Feb;66(2):213-220. doi: 10.4187/respcare.07952. Epub 2020 Sep 1.
- Individual participant dataSharing planned: Undecided. Complete protocol and individual patient data after publication of results
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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.
Inderpaul S Sehgal, MD,DM principal investigator
PGIMER,Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAVA during Non invasive ventilation and PSV during Non invasive ventilation in people with Respiratory Failure, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 16 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 10 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 India. 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?
Rates of NIV failures (time frame: 28 days). The study lists 2 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 NCT03271671, which also lists 7 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 10 Apr 2019.