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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

A Pilot Randomised Controlled Trial of Withdrawal of Non-invasive Ventilation in COPD Patients With Acute Hypercapnic Respiratory Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01523470
• Other study ID #: withdrawalNIV
• Status: Completed
• Phase: Phase 3
• First received: January 14, 2012
• Last updated: January 31, 2012
• Start date: November 2010
• Est. completion date: October 2011

Study information

• Verified date: January 2012
• Source: United Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Hypercapnia
• Hypercapnic Respiratory Failure
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Department of Medicine, United Christian Hospital, Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
United Christian Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	time from randomisation to recurrence of hypercapnic respiratory failure	time from randomisation to recurrence of hypercapnic respiratory failure	an average of 1 week in hospital stay, upto 3 weeks	No
Secondary	total stay in hospital	to compare the length of stay in hospital between two groups	an average of 1 week, upto 3 weeks	No