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

Primary Purpose

Chronic Obstructive Pulmonary Disease, Hypercapnic Respiratory Failure

Status
Completed
Phase
Phase 3
Locations
Hong Kong
Study Type
Interventional
Intervention
BIPAP Synchrony
Sponsored by
United Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring non-invasive ventilator

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Department of Medicine, United Christian Hospital, Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

stepwise withdrawal of NIV

immediate withdrawal of NIV

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

time from randomisation to recurrence of hypercapnic respiratory failure
time from randomisation to recurrence of hypercapnic respiratory failure
total stay in hospital
to compare the length of stay in hospital between two groups

Full Information

First Posted
January 14, 2012
Last Updated
January 31, 2012
Sponsor
United Christian Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01523470
Brief Title
Withdrawal of Non-invasive Ventilation in Chronic Obstructive Pulmonary Disease (COPD) Patients With Acute Hypercapnic Respiratory Failure
Official Title
A Pilot Randomised Controlled Trial of Withdrawal of Non-invasive Ventilation in COPD Patients With Acute Hypercapnic Respiratory Failure
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
United Christian Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
All patients would receive standard medical treatment with inhaled bronchodilator, systemic steroid, antibiotics according to our local bacteriology. Acute NIV was initiated by trained respiratory nurses according to standardised protocols. The nurses would be at the bedside during the initial acclimatization. BIPAP vision was used to provide bi-level pressure support ventilation. Interfacing with different types of nasal or full-mask would be individualised. NIV was used for as many as possible in the first day, at least 20 hrs. Throughout the NIV treatment, the following parameters will be monitored when NIV is started: arterial blood gases, respiratory rate, heart rate and blood pressure, mental state, pulse oximetry. If a patient failed to respond to NIV, he or she would be intubated if appropriate. Criteria for failure include lack of clinical improvement with increasing dyspnea and deterioration of blood gases, hemodynamic instability, uncontrolled ventricular arrythmia, development of hypercapnic coma and cardiopulmonary arrest. A patient would be considered suitable to withdraw from the ventilator if he or she fulfil the criteria at rest.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Hypercapnic Respiratory Failure
Keywords
non-invasive ventilator

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
stepwise withdrawal of NIV
Arm Type
Active Comparator
Arm Description
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).
Arm Title
immediate withdrawal of NIV
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
BIPAP Synchrony
Other Intervention Name(s)
BIPAP Synchrony, Respironics INC, USA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Success of NIV withdrawal
Description
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.
Time Frame
an average of 4.5 day (6 days in stepwise group and 3 days in immediate group)
Secondary Outcome Measure Information:
Title
time from randomisation to recurrence of hypercapnic respiratory failure
Description
time from randomisation to recurrence of hypercapnic respiratory failure
Time Frame
an average of 1 week in hospital stay, upto 3 weeks
Title
total stay in hospital
Description
to compare the length of stay in hospital between two groups
Time Frame
an average of 1 week, upto 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Department of Medicine, United Christian Hospital, Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

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

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