COPD ExacerbationNAVA-NICENCT02912689
NIV - NAVA vs NIV - PS for COPD Exacerbation
A study testing Neurally Adjusted Ventilator Assist and Pressure support ventilation in people with COPD Exacerbation, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
Number of Patients: Total no. of patients = 40 patients NIV-PSV group (Group A) = 20 NIV-NAVA group (Group B) = 20 Inclusion criteria a) Patients of Chronic obstructive pulmonary disease with acute hypercapnic respiratory failure (pH < 7.35 and PaCO2 >45 mmHg) requiring noninvasive ventilation and with no indication… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- COPD Exacerbation
- What is being tested?
- Neurally Adjusted Ventilator Assist and Pressure support ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2016to 31 Dec 2017
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of Chronic obstructive pulmonary disease with acute hypercapnic respiratory failure requiring noninvasive ventilation and with no indication for invasive mechanical ventilation will be included in the study.
Who cannot join
- Patient with any contraindication for insertion of nasogastric tube (like recent gastrointestinal bleeding in previous 30 days, Esophageal varices)
- Patient with any established contraindication of noninvasive ventilation. (Like Hemodynamic instability, active GI bleed etc)
- Patients with a known neuromuscular, Central or peripheral nervous system disorder.
- Patient not willing to give consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Ventilation (NIV) - Neurally Adjusted Ventilatory Assist (NAVA) vs NIV for Acute Hypercapneic Respiratory Failure in COPD: A Randomized Controlled Trial
Number of Patients:
Total no. of patients = 40 patients NIV-PSV group (Group A) = 20 NIV-NAVA group (Group B) = 20
Read more
Inclusion criteria
- Patients of Chronic obstructive pulmonary disease with acute hypercapnic respiratory failure (pH < 7.35 and PaCO2 >45 mmHg) requiring noninvasive ventilation and with no indication for invasive mechanical ventilation.
Exclusion criteria
- Patient with any contra-indication for insertion of nasogastric tube (like recent gastrointestinal bleeding in previous 30 days, esophageal varices)
- Patient with any contraindication of noninvasive ventilation (such as hemodynamic instability, active gastrointestinal bleed etc)
- Patients with a known neuromuscular, central or peripheral nervous system disorder.
- Patient not willing to give consent.
Control(s): Patients receiving pressure support ventilation (NIV-PSV) will act as control
Study design: Randomized interventional study
Dosages of drug: None
Duration of treatment: Till patient improves or requires invasive ventilation.
Brief Methodology Patients of COPD with acute exacerbation will be randomized into two groups (group A and group B) to receive NIV-PSV or NIV-NAVA respectively. A special naso-gastric catheter (EAdi-catheter) will be placed in all patients. In each mode, NIV will be applied using a non-vented oro-nasal mask that will be fitted enough to avoid air leaks. Patients in Group A will receive NIV-PS and Group B will receive ventilation via NIV-NAVA. Pressure support and PEEP levels will be set by the treating physician to achieve a tidal volume (Vt) of 6 to 8 mL/kg of ideal body weight. NAVA level will be adjusted to match peak pressures of NIV-PSV using manufacturer-supplied software. After stabilization, a 30-min period of each NIV trial will be recorded and manually analyzed offline. Subsequent readings will be taken at 2, 6 and at 24 hours and then at 6 hourly interval from day 2 onwards. In each trial, patient-ventilator asynchronies (ineffective efforts, auto triggering, premature cycling, delayed cycling, and double triggering) will be determined on EAdi, airway pressure, and flow signal. The number of each type of asynchrony, defined as the number of events per minute, will be determined for each recording period. The asynchrony index (AI), in percentage, will be calculated as described previously, and an AI >10% will be considered severe asynchrony. Patient comfort level after each mode of ventilation will be assessed by using visual analogue scale. Various clinical, ventilatory and arterial blood gas parameters will be recorded.
Statistical analysis Data will be expressed as mean ± standard deviation (SD), or percentage. Differences in continuous variables between the two groups will be compared using student's t test (or Mann-Whitney U test); while differences in categorical data will be compared using the chi- square test (or Fisher's exact test). A p value of less than 0.05 will be considered statistically significant.
- Conditions
- COPD Exacerbation
- Being tested
- Neurally Adjusted Ventilator Assist, Pressure support ventilation
- Keywords
- COPD, Non-invasive ventilation, NAVA
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurally Adjusted Ventilator AssistDevice
Also called NAVA
NAVA during Non-invasive ventilation
Pressure support ventilationDevice
Also called PSV
PS during Non-invasive ventilation
| Study group | Role | What they receive |
|---|---|---|
| Neurally adjusted ventilator assist | Experimental | Neurally adjusted ventilator assist (NAVA) during NIV for exacerbation of COPD. Receives: Device: Neurally Adjusted Ventilator Assist |
| Pressure support ventilation | Active comparator | Pressure support ventilation (PSV) during NIV for exacerbation of COPD. Receives: Device: Pressure support ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the number of patient ventilator asynchrony
To assess the difference of number of patient ventilator asynchrony
Measured: Entire period of ventilatory support, an average of 5 days
Secondary outcomes (2)
Difference in rate of NIV failure
To assess the difference of rate of NIV failure
Measured: Entire hospital stay, an average of 7 days
Difference in total duration of ventilatory support
To assess the difference in total duration of ventilatory support
Measured: Entire hospital stay, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPD ExacerbationStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Vijay Hadda, All India Institute of Medical Sciences
- Investigators
- Vijay Hadda, MD, Principal investigator, AIIMS, New Delhi, INDIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912689
- Sponsor's protocol ID
- IECPG/360/29.06.2016
- Acronym
- NAVA-NICE
- Status last verified
- Feb 2018
- First submitted
- 4 Sep 2016
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Will share, if required
Publications
Tajamul S, Hadda V, Madan K, Tiwari P, Mittal S, Khan MA, Mohan A, Guleria R. Neurally-Adjusted Ventilatory Assist Versus Noninvasive Pressure Support Ventilation in COPD Exacerbation: The NAVA-NICE Trial. Respir Care. 2020 Jan;65(1):53-61. doi: 10.4187/respcare.07122. Epub 2019 Oct 22.
PubMed 31641071
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Ventilation (NIV) - Neurally Adjusted Ventilatory Assist (NAVA) vs NIV for Acute Hypercapneic Respiratory Failure in COPD: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02912689
- Acronym / sponsor ID
- NAVA-NICE / IECPG/360/29.06.2016
- Conditions
- COPD Exacerbation
- Keywords
- COPD, Non-invasive ventilation, NAVA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 23 Sep 2016 (estimated)
- 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.
Number of Patients:
Total no. of patients = 40 patients NIV-PSV group (Group A) = 20 NIV-NAVA group (Group B) = 20
Inclusion criteria
- Patients of Chronic obstructive pulmonary disease with acute hypercapnic respiratory failure (pH < 7.35 and PaCO2 >45 mmHg) requiring noninvasive ventilation and with no indication for invasive mechanical ventilation.
Exclusion criteria
- Patient with any contra-indication for insertion of nasogastric tube (like recent gastrointestinal bleeding in previous 30 days, esophageal varices)
- Patient with any contraindication of noninvasive ventilation (such as hemodynamic instability, active gastrointestinal bleed etc)
- Patients with a known neuromuscular, central or peripheral nervous system disorder.
- Patient not willing to give consent.
Control(s): Patients receiving pressure support ventilation (NIV-PSV) will act as control
Study design: Randomized interventional study
Dosages of drug: None
Duration of treatment: Till patient improves or requires invasive ventilation.
Brief Methodology Patients of COPD with acute exacerbation will be randomized into two groups (group A and group B) to receive NIV-PSV or NIV-NAVA respectively. A special naso-gastric catheter (EAdi-catheter) will be placed in all patients. In each mode, NIV will be applied using a non-vented oro-nasal mask that will be fitted enough to avoid air leaks. Patients in Group A will receive NIV-PS and Group B will receive ventilation via NIV-NAVA. Pressure support and PEEP levels will be set by the treating physician to achieve a tidal volume (Vt) of 6 to 8 mL/kg of ideal body weight. NAVA level will be adjusted to match peak pressures of NIV-PSV using manufacturer-supplied software. After stabilization, a 30-min period of each NIV trial will be recorded and manually analyzed offline. Subsequent readings will be taken at 2, 6 and at 24 hours and then at 6 hourly interval from day 2 onwards. In each trial, patient-ventilator asynchronies (ineffective efforts, auto triggering, premature cycling, delayed cycling, and double triggering) will be determined on EAdi, airway pressure, and flow signal. The number of each type of asynchrony, defined as the number of events per minute, will be determined for each recording period. The asynchrony index (AI), in percentage, will be calculated as described previously, and an AI >10% will be considered severe asynchrony. Patient comfort level after each mode of ventilation will be assessed by using visual analogue scale. Various clinical, ventilatory and arterial blood gas parameters will be recorded.
Statistical analysis Data will be expressed as mean ± standard deviation (SD), or percentage. Differences in continuous variables between the two groups will be compared using student's t test (or Mann-Whitney U test); while differences in categorical data will be compared using the chi- square test (or Fisher's exact test). A p value of less than 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurally adjusted ventilator assist | Experimental | Device: Neurally Adjusted Ventilator AssistNeurally adjusted ventilator assist (NAVA) during NIV for exacerbation of COPD. |
| Pressure support ventilation | Active comparator | Device: Pressure support ventilationPressure support ventilation (PSV) during NIV for exacerbation of COPD. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of Chronic obstructive pulmonary disease with acute hypercapnic respiratory failure requiring noninvasive ventilation and with no indication for invasive mechanical ventilation will be included in the study.
Key exclusion criteria (4 listed)
- Patient with any contraindication for insertion of nasogastric tube (like recent gastrointestinal bleeding in previous 30 days, Esophageal varices)
- Patient with any established contraindication of noninvasive ventilation. (Like Hemodynamic instability, active GI bleed etc)
- Patients with a known neuromuscular, Central or peripheral nervous system disorder.
- Patient not willing to give consent.
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 |
|---|---|---|
| Neurally Adjusted Ventilator AssistAlso: NAVANAVA during Non-invasive ventilation | Device | Neurally adjusted ventilator assist |
| Pressure support ventilationAlso: PSVPS during Non-invasive ventilation | Device | Pressure support ventilation |
Primary outcome
Difference in the number of patient ventilator asynchrony
Time frame: Entire period of ventilatory support, an average of 5 days
To assess the difference of number of patient ventilator asynchrony
2 secondary outcomes
Difference in rate of NIV failure
Time frame: Entire hospital stay, an average of 7 days
Difference in total duration of ventilatory support
Time frame: Entire hospital stay, an average of 7 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 12 Feb 2018.
- Derived from this study: PubMed 31641071Tajamul S, Hadda V, Madan K, Tiwari P, Mittal S, Khan MA, Mohan A, Guleria R. Neurally-Adjusted Ventilatory Assist Versus Noninvasive Pressure Support Ventilation in COPD Exacerbation: The NAVA-NICE Trial. Respir Care. 2020 Jan;65(1):53-61. doi: 10.4187/respcare.07122. Epub 2019 Oct 22.
- Individual participant dataSharing planned: Yes. Will share, if required
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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.
Vijay Hadda, MD principal investigator
AIIMS, New Delhi, INDIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurally Adjusted Ventilator Assist and Pressure support ventilation in people with COPD Exacerbation, run by All India Institute of Medical Sciences 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 1 inclusion and 4 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 12 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Difference in the number of patient ventilator asynchrony (time frame: Entire period of ventilatory support, an average of 5 days). 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 NCT02912689, which also lists 1 linked publication.
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 Feb 2018.