Chronic Obstructive Pulmonary DiseasePSV vs ASV forNCT02877524
Trial to Study Intubation Rates of Non-invasive Ventilation Using Pressure Support Ventilation (PSV) Versus Adaptive Support Ventilation (ASV) Mode in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
A study testing Adaptive support ventilation and Pressure support ventilation in people with Chronic Obstructive Pulmonary Disease and Invasive Mechanical Ventilation, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
The clinical course of chronic obstructive pulmonary disease (COPD) is associated with recurrent episodes of exacerbation that results in respiratory failure. The treatment of respiratory failure is supportive and involves inhalation bronchodilators along with systemic steroids. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Invasive Mechanical Ventilation, Adaptive Support Ventilation
- What is being tested?
- Adaptive support ventilation and Pressure support ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteIndia
- Study dates
- 1 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All consecutive patients with acute exacerbation of COPD will be assessed for inclusion in the current study. The diagnosis of acute exacerbation of COPD will be made based on following criteria:
- an acute sustained worsening of any of the patient's respiratory symptoms (cough, sputum quantity and/or character, dyspnea) that is beyond normal day today variation and leads to a change in medication
- arterial blood gas analysis showing a PaCO2>45 mm of Hg with either pH <7.35 ≥7.26 or respiratory rate >30/minute
- exclusion of other causes of acute breathlessness such as acute heart failure, pulmonary embolism, pneumonia, and pneumothorax.
Who cannot join
- Patients with any one of the following criteria will be excluded from the current study:
- non-COPD acute hyper-capneic respiratory failure.
- hypotension (systolic blood pressure<90mmHg),
- severe encephalopathy (Glasgow coma scale score < 8),
- upper gastrointestinal bleeding
- inability to protect the airway and clear respiratory secretions, or abnormalities that preclude proper fit of the interface (agitated or uncooperative patient, facial trauma or burns, facial surgery, or facial anatomical abnormality).
- patients who are on home NIV.
- failure to give 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
The clinical course of chronic obstructive pulmonary disease (COPD) is associated with recurrent episodes of exacerbation that results in respiratory failure. The treatment of respiratory failure is supportive and involves inhalation bronchodilators along with systemic steroids. In few cases the management of acute respiratory failure requires positive pressure ventilation (non-invasive or invasive). The use of NIV in acute exacerbation of COPD has resulted in significant reduction in morbidity and mortality. Although pressure support ventilation (PSV) allows the patient to influence the breathing pattern, ventilator-cycling criteria may worsen the patient-ventilator interaction, and severe asynchronies occur in up to 43% of patients undergoing NIV for ARF. Adaptive support ventilation (ASV) is a newer mode of ventilation that incorporates feedback mechanisms and thus provides a stable minute ventilation. We hypothesize that the use of ASV as a mode during ventilation using NIV in patients with acute exacerbation of COPD may result in reducing the duration of ventilatory support, need for intubation, and duration of intensive care unit (ICU) and hospital length of stay, when compared with PSV mode of NIV ventilation.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a common respiratory disease, which is characterized by airflow limitation. It affects more than 3.49 per cent of adults >35 year and is associated with high morbidity and mortality. The national burden of chronic bronchitis is estimated at 14.84 million.
The clinical course of COPD is punctuated by acute exacerbations, which can lead to hypercapnic respiratory failure. The development of respiratory failure is associated with high morbidity and mortality, and significant healthcare costs. The requirement of ventilatory support also portends a reduced survival in this group of patients.
The introduction of non-invasive ventilation (NIV) has resulted in a paradigm shift in the management of patients with acute exacerbation of COPD. First, reported in 1989, by Meduri et all, the successful application of NIV via full-face mask in 10 patients, and the avoidance of intubation in 8 of them (4 of 6 with COPD, 2 of 2 with congestive heart failure, and 2 of 2 with pneumonia), demonstrated the efficacy of NIV in the management of acute exacerbation of COPD. This new modality was successful in avoiding of many of the complications associated with invasive mechanical ventilation.
Traditionally, NIV is instituted with the pressure support mode of ventilation. Wherein, the inspiratory pressure was initiated at 6-8 cm of water and expiratory pressure was set at 3-4 cm. The difference between the two pressures provided the ventilatory support. These pressures were then titrated based on patient clinical improvement by the physician.
Adaptive support ventilation (ASV) is one of the newer modes of ventilation, described by Tehrani et al in 1991 and was designed to minimise the work of breathing, mimic natural breathing and stimulate breathing and reduce weaning time. It is a closed loop system, which incorporates various feedback mechanisms into its algorithm. The operator inputs patients weight, from that the ventilator calculates required minute alveolar ventilation assuming normal dead space fraction. Then an optimal frequency is calculated based on Otis equation. The target tidal volume is calculated by MV/f. The inspiratory pressure within a breath is controlled to achieve a constant value and between the breaths the inspiratory pressure is adjusted to achieve a target tidal volume. It aims to provide a target minute ventilation by adjusting automatically the delivered pressure and respiratory rate while keeping the work of breathing to a minimum by the patient.
Due to its ability to reduce the work of breathing and meet the flow requirement of the patient by adjusting both the flow and respiratory rate depending on the respiratory mechanics, the use of ASV as a mode of ventilation during NIV may improve patient-ventilator synchrony. A study comparing ASV versus pressure support ventilation in intubated patients with acute exacerbation of COPD demonstrated that the use of ASV mode was associated with shorter weaning times with similar weaning success rates. However, a study comparing the use of ASV mode versus PSV mode during non-invasive ventilation has not been done previously. Patient-ventilator synchronization is critical for reducing the work of breathing and for successful NIV. Although PSV allows the patient to influence the breathing pattern, ventilator-cycling criteria may worsen the patient-ventilator interaction, and severe asynchronies occur in up to 43% of patients undergoing NIV for ARF. We hypothesize that the use of ASV as a mode during ventilation using NIV in patients with acute exacerbation of COPD may result in reducing the duration of ventilatory support, need for intubation, and duration of intensive care unit (ICU) and hospital length of stay, when compared with PSV mode of NIV ventilation.
- Conditions
- Chronic Obstructive Pulmonary Disease, Invasive Mechanical Ventilation, Adaptive Support Ventilation
- Being tested
- Adaptive support ventilation, Pressure support ventilation
- 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.
Adaptive support ventilationOther
Also called ASV
ASV during NIV
Pressure support ventilationOther
Also called PSV
PSV during NIV
| Study group | Role | What they receive |
|---|---|---|
| Adaptive support ventilation | Experimental | Adaptive support ventilation during NIV for acute exacerbation of COPD Receives: Other: Adaptive support ventilation |
| Pressure support ventilation | Active comparator | Pressure support ventilation during NIV for acute exacerbation of COPD Receives: Other: Pressure support ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the rate of NIV success
To assess the difference in the rate of NIV success using either PSV or ASV mode of ventilation
Measured: 28 days after discharge
Secondary outcomes (4)
Patient comfort
Assess patient comfort using VAS score
Measured: 28 days after discharge
Duration of mechanical ventilation
Duration of mechanical ventilation (both non-invasive and invasive)
Measured: 28 days after discharge
Time to weaning
Total time to wean from positive airway pressure ventilation
Measured: 28 days after discharge
ICU and hospital length of stay
Total duration of hospital and intensive care unit stay
Measured: 28 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study start1 Sep 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 Chronic Obstructive Pulmonary DiseaseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 74 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
- Ritesh Agarwal, Study director, PGIMER,Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877524
- Sponsor's protocol ID
- NK/2609/DM/105
- Acronym
- PSV vs ASV for
- Status last verified
- Jan 2018
- First submitted
- 17 Aug 2016
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sehgal IS, Kalpakam H, Dhooria S, Aggarwal AN, Prasad KT, Agarwal R. A Randomized Controlled Trial of Noninvasive Ventilation with Pressure Support Ventilation and Adaptive Support Ventilation in Acute Exacerbation of COPD: A Feasibility Study. COPD. 2019 Apr;16(2):168-173. doi: 10.1080/15412555.2019.1620716. Epub 2019 Jun 4.
PubMed 31161812
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial to Study Intubation Rates of Non-invasive Ventilation Using Pressure Support Ventilation (PSV) Versus Adaptive Support Ventilation (ASV) Mode in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02877524
- Acronym / sponsor ID
- PSV vs ASV for / NK/2609/DM/105
- Conditions
- Chronic Obstructive Pulmonary Disease, Invasive Mechanical Ventilation, Adaptive Support Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 24 Aug 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.
The clinical course of chronic obstructive pulmonary disease (COPD) is associated with recurrent episodes of exacerbation that results in respiratory failure. The treatment of respiratory failure is supportive and involves inhalation bronchodilators along with systemic steroids. In few cases the management of acute respiratory failure requires positive pressure ventilation (non-invasive or invasive). The use of NIV in acute exacerbation of COPD has resulted in significant reduction in morbidity and mortality. Although pressure support ventilation (PSV) allows the patient to influence the breathing pattern, ventilator-cycling criteria may worsen the patient-ventilator interaction, and severe asynchronies occur in up to 43% of patients undergoing NIV for ARF. Adaptive support ventilation (ASV) is a newer mode of ventilation that incorporates feedback mechanisms and thus provides a stable minute ventilation. We hypothesize that the use of ASV as a mode during ventilation using NIV in patients with acute exacerbation of COPD may result in reducing the duration of ventilatory support, need for intubation, and duration of intensive care unit (ICU) and hospital length of stay, when compared with PSV mode of NIV ventilation.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a common respiratory disease, which is characterized by airflow limitation. It affects more than 3.49 per cent of adults >35 year and is associated with high morbidity and mortality. The national burden of chronic bronchitis is estimated at 14.84 million.
The clinical course of COPD is punctuated by acute exacerbations, which can lead to hypercapnic respiratory failure. The development of respiratory failure is associated with high morbidity and mortality, and significant healthcare costs. The requirement of ventilatory support also portends a reduced survival in this group of patients.
The introduction of non-invasive ventilation (NIV) has resulted in a paradigm shift in the management of patients with acute exacerbation of COPD. First, reported in 1989, by Meduri et all, the successful application of NIV via full-face mask in 10 patients, and the avoidance of intubation in 8 of them (4 of 6 with COPD, 2 of 2 with congestive heart failure, and 2 of 2 with pneumonia), demonstrated the efficacy of NIV in the management of acute exacerbation of COPD. This new modality was successful in avoiding of many of the complications associated with invasive mechanical ventilation.
Traditionally, NIV is instituted with the pressure support mode of ventilation. Wherein, the inspiratory pressure was initiated at 6-8 cm of water and expiratory pressure was set at 3-4 cm. The difference between the two pressures provided the ventilatory support. These pressures were then titrated based on patient clinical improvement by the physician.
Adaptive support ventilation (ASV) is one of the newer modes of ventilation, described by Tehrani et al in 1991 and was designed to minimise the work of breathing, mimic natural breathing and stimulate breathing and reduce weaning time. It is a closed loop system, which incorporates various feedback mechanisms into its algorithm. The operator inputs patients weight, from that the ventilator calculates required minute alveolar ventilation assuming normal dead space fraction. Then an optimal frequency is calculated based on Otis equation. The target tidal volume is calculated by MV/f. The inspiratory pressure within a breath is controlled to achieve a constant value and between the breaths the inspiratory pressure is adjusted to achieve a target tidal volume. It aims to provide a target minute ventilation by adjusting automatically the delivered pressure and respiratory rate while keeping the work of breathing to a minimum by the patient.
Due to its ability to reduce the work of breathing and meet the flow requirement of the patient by adjusting both the flow and respiratory rate depending on the respiratory mechanics, the use of ASV as a mode of ventilation during NIV may improve patient-ventilator synchrony. A study comparing ASV versus pressure support ventilation in intubated patients with acute exacerbation of COPD demonstrated that the use of ASV mode was associated with shorter weaning times with similar weaning success rates. However, a study comparing the use of ASV mode versus PSV mode during non-invasive ventilation has not been done previously. Patient-ventilator synchronization is critical for reducing the work of breathing and for successful NIV. Although PSV allows the patient to influence the breathing pattern, ventilator-cycling criteria may worsen the patient-ventilator interaction, and severe asynchronies occur in up to 43% of patients undergoing NIV for ARF. We hypothesize that the use of ASV as a mode during ventilation using NIV in patients with acute exacerbation of COPD may result in reducing the duration of ventilatory support, need for intubation, and duration of intensive care unit (ICU) and hospital length of stay, when compared with PSV mode of NIV ventilation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adaptive support ventilation | Experimental | Other: Adaptive support ventilationAdaptive support ventilation during NIV for acute exacerbation of COPD |
| Pressure support ventilation | Active comparator | Other: Pressure support ventilationPressure support ventilation during NIV for acute exacerbation of COPD |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All consecutive patients with acute exacerbation of COPD will be assessed for inclusion in the current study. The diagnosis of acute exacerbation of COPD will be made based on following criteria:
- an acute sustained worsening of any of the patient's respiratory symptoms (cough, sputum quantity and/or character, dyspnea) that is beyond normal day today variation and leads to a change in medication
- arterial blood gas analysis showing a PaCO2>45 mm of Hg with either pH <7.35 ≥7.26 or respiratory rate >30/minute
- exclusion of other causes of acute breathlessness such as acute heart failure, pulmonary embolism, pneumonia, and pneumothorax.
Key exclusion criteria (8 listed)
- non-COPD acute hyper-capneic respiratory failure.
- hypotension (systolic blood pressure<90mmHg),
- severe encephalopathy (Glasgow coma scale score < 8),
- upper gastrointestinal bleeding
- inability to protect the airway and clear respiratory secretions, or abnormalities that preclude proper fit of the interface (agitated or uncooperative patient, facial trauma or burns, facial surgery, or facial anatomical abnormality).
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 |
|---|---|---|
| Adaptive support ventilationAlso: ASVASV during NIV | Other | Adaptive support ventilation |
| Pressure support ventilationAlso: PSVPSV during NIV | Other | Pressure support ventilation |
Primary outcome
Difference in the rate of NIV success
Time frame: 28 days after discharge
To assess the difference in the rate of NIV success using either PSV or ASV mode of ventilation
4 secondary outcomes
Patient comfort
Time frame: 28 days after discharge
Duration of mechanical ventilation
Time frame: 28 days after discharge
Time to weaning
Time frame: 28 days after discharge
ICU and hospital length of stay
Time frame: 28 days after discharge
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 3 Jan 2018.
- Derived from this study: PubMed 31161812Sehgal IS, Kalpakam H, Dhooria S, Aggarwal AN, Prasad KT, Agarwal R. A Randomized Controlled Trial of Noninvasive Ventilation with Pressure Support Ventilation and Adaptive Support Ventilation in Acute Exacerbation of COPD: A Feasibility Study. COPD. 2019 Apr;16(2):168-173. doi: 10.1080/15412555.2019.1620716. Epub 2019 Jun 4.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
Ritesh Agarwal study director
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 Adaptive support ventilation and Pressure support ventilation in people with Chronic Obstructive Pulmonary Disease and Invasive Mechanical Ventilation, 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 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: finished, as of the sponsor's last update on 3 Jan 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 rate of NIV success (time frame: 28 days after discharge). 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 NCT02877524, 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 3 Jan 2018.