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

NCT06160687 | Completed DMC

• 1 other identifier: DM-1129
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

COPD Exacerbation Acute; COPD Exacerbation

Outcome Measures

Primary Outcomes (1)

• Non-invasive ventilation (NIV) failure

  NIV failure will be defined by need for endotracheal intubation

  28 days

Secondary Outcomes (6)

• Mortality

  28 days

• Time to NIV failure

  28 days

• Duration of ventilation

  28 days

• Physician and patient comfort using visual analog scale (VAS)

  28 days

• Asynchrony index

  28 days

Study Arms (2)

PSV arm

ACTIVE COMPARATOR

Delivery of NIV using PSV mode

Procedure: PSV mode during NIV

ASV intellisync arm

EXPERIMENTAL

Delivery of NIV using Intelllisync ASV

Procedure: ASV intellisync

Interventions

PSV mode during NIV PROCEDURE

NIV will be delivered using PSV mode of ventilation

PSV arm

ASV intellisync PROCEDURE

ASV intellisync mode will be used to deliver NIV

ASV intellisync arm

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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 \<90 mmHg).
• Severe impairment of consciousness (Glasgow coma scale score \<8).
• Inability to clear respiratory secretions.
• 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.
• Patient already on home NIV therapy for chronic respiratory failure.
• Failure to provide informed consent.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Respiratory ICU, Department of Pulmonary Medicine, PGIMER

Chandigarh, Chandigarh, 160012, India

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: December 1, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

IN (1)