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

NCT02877524 | Completed DMC

• 1 other identifier: NK/2609/DM/105
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Obstructive Pulmonary Disease; Invasive Mechanical Ventilation; Adaptive Support Ventilation

Outcome Measures

Primary Outcomes (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

  28 days after discharge

Secondary Outcomes (4)

• Patient comfort

  28 days after discharge

• Duration of mechanical ventilation

  28 days after discharge

• Time to weaning

  28 days after discharge

• ICU and hospital length of stay

  28 days after discharge

Study Arms (2)

Adaptive support ventilation

EXPERIMENTAL

Adaptive support ventilation during NIV for acute exacerbation of COPD

Other: Adaptive support ventilation

Pressure support ventilation

ACTIVE COMPARATOR

Pressure support ventilation during NIV for acute exacerbation of COPD

Other: Pressure support ventilation

Interventions

Adaptive support ventilation OTHER

ASV during NIV

Also known as: ASV

Adaptive support ventilation

Pressure support ventilation OTHER

PSV during NIV

Also known as: PSV

Pressure support ventilation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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\<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.

Sponsors & Collaborators

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

Study Sites (1)

Respiratory ICU, Post Graduate Institue of Medical Education and Research

Chandigarh, 160012, India

Location

Related Publications (1)

• 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.

  PMID: 31161812 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ritesh Agarwal

  PGIMER,Chandigarh

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Pulmonary Medicine

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 24, 2016
• Study Start: September 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: January 3, 2018

Record last verified: 2018-01

Locations

IN (1)