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NCT06160687Completed

PSV Versus ASV With Intellisync Mode for Delivery of NIV in AECOPD

Randomised Control Trial to Study the Role of Non-invasive Ventilation Using Pressure Support Ventilation Versus Adaptive Support Ventilation With Intellisync Mode in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Source: ClinicalTrials.gov · Last updated 23 Jul 2025

Brief summary (registry, in English)

Acute exacerbation of chronic obstructive pulmonary disease (COPD) is defined acute worsening of respiratory symptoms requiring additional therapy. COPD exacerbations affects the health status and quality of life of affected patients. The inpatient mortality during exacerbation is 3 to 4% while, intensive care unit (ICU) mortality approaches 43 to 46%. Each episode of exacerbation increases the risk of mortality subsequently(1) Non-invasive ventilation (NIV) therapy has established role in mild to moderate exacerbations of COPD. But the use of NIV therapy outside of acute exacerbation is uncertain(2) NIV use has been shown to prevent endotracheal intubation and improved hospital and ICU survival. NIV decreases the work of breathing by unloading the respiratory muscles through assisting the inspiratory phases and counterbalancing the intrinistic positive end expiratory positive pressure (ipeep)(3). NIV is delivered through face mask, although newer interfaces like helmet available(3). Tradionally pressure targeted mode is used in NIV therapy and is often given intermittently rather than continuously(4). NIV therapy via face mask was first used by Meduri et. Al in acute respiratory failure patients. Subsequent multiple randomized control trials established the role of NIV therapy in better gas exchange, reducing PCO2, reducing endotracheal intubation thereby reducing mortality, length of stay in hospital(3). NIV-PSV (pressure support ventilation) consists of 2 pressures. IPAP (inspiratory positive airway pressure) and EPAP (expiratory positive airway pressure) or PEEP. Pressure support is usually the pressure added above PEEP. Pressure support is usually started with 8-10 cm H2O to obtain a tidal volume of 6-8ml/kg ideal body weight. EPAP/PEEP is adjusted to counterbalance the iPEEP. It is usually kept at 4-6cm H2O. Fio2 is kept to maintain saturation of 88-92%. Inspiratory trigger is usually set at 1 L/min. Expiratory trigger kept at 50%. Back up rate should always be kept usually lower than the patient respiratory rate 10-12 breaths/min(5). Adaptive support ventilation (ASV) is a new method of closed loop ventilation which can switch back between pressure support and pressure control modes of ventilation. Based on the ideal body weight and % of minute volume ventilation given, the ASV mode choses the best tidal volume and respiratory rate according to the patient lung mechanics by calculating expiratory time constant (RCe) through expiratory flow volume curve(6). Since closed loop system, being a completely automated system, prevent frequent adjustment by clinician and thereby increasing the time and capacity of medical staff. The first application of such closed loop system in mechanical ventilation was done by saxton in1953 in iron lung for regulation of etCO2(7). Studies published on ASV as non-invasive mode of ventilation is limited. In a feasibility study, it has been shown that ASV can be used in non-invasive mode of ventilation with similar results to PSV in COPD patients(8).

Status (registry)
Completed
Study type
Interventional
Enrollment
55 (actual)
First submitted
29 Nov 2023
Start date
1 Dec 2023
Primary completion date
30 Apr 2025
Lead sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Diseases
COPD
NCT number
NCT06160687

What you commit to

  • Study type: Interventional
  • Participants enrolled: 55
  • From 1 Dec 2023 to the primary completion date, 30 Apr 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Abnormalities that preclude proper fit of the NIV interface (agitated or uncooperative patient, facial trauma or burns, facial surgery, or facial anatomical abnormality).

Other illness

  • Non-COPD acute hyper-capneic respiratory failure.
  • Severe impairment of consciousness (Glasgow coma scale score \<8).
  • Patient already on home NIV therapy for chronic respiratory failure.
  • Failure to provide informed consent.

Other

  • Patients with any one of the following criteria will be excluded from the current study:
  • Hypotension (systolic blood pressure \<90 mmHg).
  • Inability to clear respiratory secretions.
  • Subjects who have an artificial airway like tracheostomy tube or T-tube.

Who the study is looking for

  • Consecutive subjects with AECOPD will be eligible for inclusion in the study if they meet all the following:
  • an acute (\<7 days) sustained worsening of any of the patient's respiratory symptoms (cough, sputum quantity or character, dyspnea) beyond the normal day-to-day variation;
  • arterial blood gas analysis showing a PaCO2 \>45 mm Hg with either pH between 7.25 and 7.35 or respiratory rate (18) \>30 breaths/minute; and,
  • exclusion of other causes of acute breathlessness such as acute heart failure, pulmonary embolism, pneumonia, and pneumothorax.

Age in the registry: 13 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Respiratory ICU, Department of Pulmonary Medicine, PGIMER
Coordinator of this site? Confirm its status
ChandigarhIndiaUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.