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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in India

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.

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 groups in NCT02877524
Study groupRoleWhat they receive
Adaptive support ventilationExperimentalAdaptive support ventilation during NIV for acute exacerbation of COPD
Receives: Other: Adaptive support ventilation
Pressure support ventilationActive comparatorPressure 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.

  1. 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)
  1. Patient comfort

    Assess patient comfort using VAS score

    Measured: 28 days after discharge

  2. Duration of mechanical ventilation

    Duration of mechanical ventilation (both non-invasive and invasive)

    Measured: 28 days after discharge

  3. Time to weaning

    Total time to wean from positive airway pressure ventilation

    Measured: 28 days after discharge

  4. 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.

  1. First posted24 Aug 2016 (estimated)
  2. Study start1 Sep 2016
  3. Primary completion31 Dec 2017
  4. Study completion31 Dec 2017

Resources

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)
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

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.

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