Comparison of Pressure Support and Pressure Control Ventilation in Chronic Respiratory Failure

A Pilot Study: Comparing Physiological Parameters and Outcome Variables Using Pressure Support Ventilation Versus Pressure Controlled Ventilation in Patients With Chronic Respiratory Failure

This study is looking at whether there is a difference in outcomes using two different types of breathing support in those patients who have chronic respiratory failure (patients who under-breathe).

There is little data to demonstrate which mode of ventilation is better in terms of physiological outcomes and outcome data relating to patient symptoms.

We hypothesize that one type of breathing support: pressure support ventilation would be more comfortable for patients as it more closely matches a patient's own respiratory pattern and and so leads to improved adherence and consequent improvement in quality of life.

Patients with respiratory failure will be randomly assigned to receive either pressure support ventilation or pressure control ventilation for the first 6 weeks and then cross-over to receive the mode not previously used for a further 6 weeks. They will have baseline data recorded and then be followed up after each 6 week block.

Study Overview

• Status: Unknown
• Conditions: COPD; Neuromuscular Disease; Chest Wall Disease; Obesity Hypoventilation
• Intervention / Treatment: Other: Pressure support ventilation; Other: Pressure control ventilation

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 7EH
    • Recruiting
    • Guy's and St Thomas' NHS Foundation Trust
    • Contact: Karen Ignathian; Phone Number: 85731 00 44 207188 7188
    • Principal Investigator: Kate Brignall, MB BS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with chest wall deformity, neuromuscular disease or obesity hypoventilation syndrome with an FEV1/FVC ratio of >70% and VC <50% predicted or patients with COPD with a FEV1/FVC ratio of <70% an FEV1 <50% predicted

• Stable

  • pH >7.35
  • ESS <18
  • Symptomatically stable with clinical resolution of intercurrent infection: normal C reactive protein, white cell count and afebrile
• Daytime symptoms compatible with nocturnal hypoventilation i.e. poor sleep, morning headache, daytime somnolence, shortness of breath
• Arterial carbon dioxide partial pressure (PaCO2) > 6.0kPa during day with evidence of nocturnal hypoventilation (TcCO2 >7.5KPa or a rise in TcCO2 of >1 KPa)
• No prior domiciliary ventilation use
• Patients with COPD must be established on optimal medical treatment prior to enrolment

Exclusion Criteria:

• Psychological, social or geographical situation that would impair compliance with the schedule
• Patients who have underlying malignancy or severe cardiac dysfunction (ejection fraction <40%)
• Complex OSA

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pressure support ventilation	Other: Pressure support ventilation; Pressure support ventilation
Active Comparator: Pressure control ventilation	Other: Pressure control ventilation; Pressure control ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adherence to ventilation	6 and 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Arterial blood gases	6 and 12 weeks
Health related quality of life as measured by CRQ and SRI	6 and 12 weeks
Breathlessness (MRC dyspnoea score)	6 and 12 weeks
Assessment of daytime vigilance and fatigue by the Epworth sleepiness score,Oxford sleep resistance test and the fatigue severity score.	6 and 12 weeks
Sleep comfort as assessed by a visual analogue scale	6 and 12 weeks
Spirometry: forced expiratory volume in 1s and forced vital capacity	6 and 12 weeks
Respiratory muscle strength: maximum inspiratory pressure, maximum expiratory pressure and sniff nasal pressure	6 and 12 weeks
Sleep fragmentation as assessed by actigraphy	2 week perids from 4 and 10 weeks
Patient ventilator synchrony as measured by number of ineffective efforts	6 and 12 weeks

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Investigators: Study Chair: A Davidson, MA, MD, Guys's and St Thomas' NHS foundation trust; Principal Investigator: N Hart, MB BS, PhD, Guy's and St Thomas' Foundation Trust; Principal Investigator: K Brignall, MB ChB, Guy's and St Thomas' NHS Foundation Trust

Publications and helpful links

General Publications

• Murphy PB, Brignall K, Moxham J, Polkey MI, Davidson AC, Hart N. High pressure versus high intensity noninvasive ventilation in stable hypercapnic chronic obstructive pulmonary disease: a randomized crossover trial. Int J Chron Obstruct Pulmon Dis. 2012;7:811-8. doi: 10.2147/COPD.S36151. Epub 2012 Dec 11.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Anticipated): April 1, 2010

Study Registration Dates

• First Submitted: October 13, 2009
• First Submitted That Met QC Criteria: October 13, 2009
• First Posted (Estimate): October 14, 2009

Study Record Updates

• Last Update Posted (Estimate): October 14, 2009
• Last Update Submitted That Met QC Criteria: October 13, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypoventilation; Neuromuscular Diseases
• Other Study ID Numbers: 09/H0802/3