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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00994552
Recruitment Status : Unknown
Verified October 2009 by Guy's and St Thomas' NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : October 14, 2009
Last Update Posted : October 14, 2009
Information provided by:
Guy's and St Thomas' NHS Foundation Trust

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
COPD Chest Wall Disease Neuromuscular Disease Obesity Hypoventilation Other: Pressure support ventilation Other: Pressure control ventilation Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Pilot Study: Comparing Physiological Parameters and Outcome Variables Using Pressure Support Ventilation Versus Pressure Controlled Ventilation in Patients With Chronic Respiratory Failure
Study Start Date : August 2009
Estimated Primary Completion Date : April 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Pressure support ventilation
Pressure support ventilation
Other: Pressure support ventilation
Pressure support ventilation

Active Comparator: Pressure control ventilation
Pressure control ventilation
Other: Pressure control ventilation
Pressure control ventilation

Primary Outcome Measures :
  1. Adherence to ventilation [ Time Frame: 6 and 12 weeks ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00994552

Contact: Katherine Brignall, MB ChB 0044 20 7188 7188 ext 88070
Contact: Patrick Murphy, MB BS 0044 20 71887188 ext 88070

United Kingdom
Guy's and St Thomas' NHS Foundation Trust Recruiting
London, United Kingdom, SE1 7EH
Contact: Karen Ignathian    00 44 207188 7188 ext 85731      
Principal Investigator: Kate Brignall, MB BS         
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
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 automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Karen Ignathian, Guy's and St Thomas' NHS Foundation Trust Identifier: NCT00994552     History of Changes
Other Study ID Numbers: 09/H0802/3
First Posted: October 14, 2009    Key Record Dates
Last Update Posted: October 14, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Respiratory Insufficiency
Neuromuscular Diseases
Respiration Disorders
Respiratory Tract Diseases
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms