Withdrawal of Non-invasive Ventilation in Chronic Obstructive Pulmonary Disease (COPD) Patients With Acute Hypercapnic Respiratory Failure

NCT01523470 | Completed Phase 3 DMC

• 1 other identifier: withdrawalNIV
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators design a pilot randomised, single-centred, controlled trial to compare different withdrawal methods of Non-invasive ventilation. Our study aims at comparing stepwise withdrawal of Non-invasive ventilation versus immediate withdrawal of Non-invasive ventilation. The primary endpoint is to compare the rate of success between two withdrawal methods. The investigators define success as no recurrence of acute hypercapnic respiratory failure or restitution of Non-invasive ventilation within 48 hours after NIV is stopped. The secondary endpoints include time to recurrence of acute hypercapnic respiratory failure measured from the time of randomisation, the total days of Non-invasive ventilation use and the days of hospitalisation. Results from this trial will inform design of future randomised trial in this area.

Conditions

Chronic Obstructive Pulmonary Disease; Hypercapnic Respiratory Failure

Keywords

non-invasive ventilator

Outcome Measures

Primary Outcomes (1)

• Success of NIV withdrawal

  Success of NIV withdrawal would be considered if there is no deterioration of clinical condition or arterial blood gases from time of randomisation to 48 hours after complete withdrawal of NIV.

  an average of 4.5 day (6 days in stepwise group and 3 days in immediate group)

Secondary Outcomes (2)

• time from randomisation to recurrence of hypercapnic respiratory failure

  an average of 1 week in hospital stay, upto 3 weeks

• total stay in hospital

  an average of 1 week, upto 3 weeks

Study Arms (2)

stepwise withdrawal of NIV

ACTIVE COMPARATOR

On the day of decision of withdrawal (day0), the duration of non-invasive ventilator (NIV) will be decreased to 16 hours. On the following day (day1), the duration of NIV will be further decreased to 12 hours. The duration will be further decreased to 8 hours at night on the following day (day 2), and it will be stopped on the day after (day 3). Vital signs and blood gases will be monitored for a total of 5 days after withdrawal is planned (day 0 to day 5).

Device: BIPAP Synchrony

immediate withdrawal of NIV

EXPERIMENTAL

The patient will have immediate withdrawal of non-invasive ventilator (NIV). Vital signs and blood gases will be monitored for 2 more days after NIV is stopped (day 0-2).

Device: BIPAP Synchrony

Interventions

BIPAP Synchrony DEVICE

BIPAP Synchrony is a machine for non-invasive ventilation for acute hypercapnic respiratory failure in chronic obstructive airway disease exacerbation. It is a temporary measure. It is proven to be effective and reduce mortality and intubation in COAD exacerbation. However, the method of withdrawal of the machine remained controversial.

Also known as: BIPAP Synchrony, Respironics INC, USA

immediate withdrawal of NIV; stepwise withdrawal of NIV

Eligibility Criteria

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

You may qualify if:

• COPD patients with AHRF requiring NIV
• the patient is cooperative with NIV treatment
• the patient is willing to give their written informed consent to participate in the study
• patient is stabilised after acute treatment after NIV as evidenced by ALL of the below::
• normalisation of arterial pH
• clinical stability as evidenced by
• SpO2 \> 88% on 2LO2 or less
• respiratory rate \< 25
• heart rate \< 120 bpm
• systolic blood pressure \> 90 mmHg
• patient not in agitation, diaphoresis or anxiety

You may not qualify if:

• patients with non-COPD causes of AHRF, for example, chest infection and heart failure
• patients who are currently on home NIV
• patients who have contraindications to NIV and those who refused or failed NIV during an initial 15 minutes acclimatization period
• other significant co-morbid conditions that in the investigators' view , would confer an adverse prognosis during the study period

Sponsors & Collaborators

• United Christian Hospital: lead

Study Sites (1)

Department of Medicine, United Christian Hospital, Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: January 14, 2012
• First Posted: February 1, 2012
• Study Start: November 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: February 1, 2012

Record last verified: 2012-01

Locations

HK (1)