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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lun Chung Tat, United Christian Hospital
ClinicalTrials.gov Identifier:
NCT01523470
First received: January 14, 2012
Last updated: January 31, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Hypercapnic Respiratory Failure
Device: BIPAP Synchrony
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Randomised Controlled Trial of Withdrawal of Non-invasive Ventilation in COPD Patients With Acute Hypercapnic Respiratory Failure

Resource links provided by NLM:


Further study details as provided by United Christian Hospital:

Primary Outcome Measures:
  • Success of NIV withdrawal [ Time Frame: an average of 4.5 day (6 days in stepwise group and 3 days in immediate group) ] [ Designated as safety issue: No ]
    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 Frame: an average of 1 week in hospital stay, upto 3 weeks ] [ Designated as safety issue: No ]
    time from randomisation to recurrence of hypercapnic respiratory failure

  • total stay in hospital [ Time Frame: an average of 1 week, upto 3 weeks ] [ Designated as safety issue: No ]
    to compare the length of stay in hospital between two groups


Enrollment: 60
Study Start Date: November 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: stepwise withdrawal of NIV
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
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.
Other Name: BIPAP Synchrony, Respironics INC, USA
Experimental: immediate withdrawal of NIV
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
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.
Other Name: BIPAP Synchrony, Respironics INC, USA

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01523470

Locations
Hong Kong
Department of Medicine, United Christian Hospital, Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
United Christian Hospital
  More Information

No publications provided

Responsible Party: Lun Chung Tat, Resident, United Christian Hospital
ClinicalTrials.gov Identifier: NCT01523470     History of Changes
Other Study ID Numbers: withdrawalNIV
Study First Received: January 14, 2012
Last Updated: January 31, 2012
Health Authority: Hong Kong: Ethics Committee

Keywords provided by United Christian Hospital:
non-invasive ventilator

Additional relevant MeSH terms:
Hypercapnia
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Hypoventilation
Respiratory Insufficiency
Lung Diseases, Obstructive
Signs and Symptoms, Respiratory
Signs and Symptoms
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 24, 2014