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 (PSV vs ASV for)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Invasive Mechanical Ventilation; Adaptive Support Ventilation
• Intervention / Treatment: Other: Adaptive support ventilation; Other: Pressure support 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 Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • Respiratory ICU, Post Graduate Institue of Medical Education and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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:

1. 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
2. arterial blood gas analysis showing a PaCO2>45 mm of Hg with either pH <7.35 ≥7.26 or respiratory rate >30/minute
3. exclusion of other causes of acute breathlessness such as acute heart failure, pulmonary embolism, pneumonia, and pneumothorax.

Exclusion Criteria:

Patients with any one of the following criteria will be excluded from the current study:

1. non-COPD acute hyper-capneic respiratory failure.
2. hypotension (systolic blood pressure<90mmHg),
3. severe encephalopathy (Glasgow coma scale score < 8),
4. upper gastrointestinal bleeding
5. 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).
6. patients who are on home NIV.
7. failure to give consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adaptive support ventilation; Adaptive support ventilation during NIV for acute exacerbation of COPD	Other: Adaptive support ventilation; ASV during NIV; Other Names: ASV
Active Comparator: Pressure support ventilation; Pressure support ventilation during NIV for acute exacerbation of COPD	Other: Pressure support ventilation; PSV during NIV; Other Names: PSV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	28 days after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient comfort	Assess patient comfort using VAS score	28 days after discharge
Duration of mechanical ventilation	Duration of mechanical ventilation (both non-invasive and invasive)	28 days after discharge
Time to weaning	Total time to wean from positive airway pressure ventilation	28 days after discharge
ICU and hospital length of stay	Total duration of hospital and intensive care unit stay	28 days after discharge

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research
• Investigators: Study Director: Ritesh Agarwal, PGIMER,Chandigarh

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: August 17, 2016
• First Submitted That Met QC Criteria: August 19, 2016
• First Posted (Estimate): August 24, 2016

Study Record Updates

• Last Update Posted (Actual): January 3, 2018
• Last Update Submitted That Met QC Criteria: January 1, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: NK/2609/DM/105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No