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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Guy's and St Thomas' NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00994552
First received: October 13, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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 Intervention Phase
COPD
Chest Wall Disease
Neuromuscular Disease
Obesity Hypoventilation
Other: Pressure support ventilation
Other: Pressure control ventilation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Guy's and St Thomas' NHS Foundation Trust:

Primary Outcome Measures:
  • Adherence to ventilation [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Arterial blood gases [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]
  • Health related quality of life as measured by CRQ and SRI [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]
  • Breathlessness (MRC dyspnoea score) [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Sleep comfort as assessed by a visual analogue scale [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]
  • Spirometry: forced expiratory volume in 1s and forced vital capacity [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]
  • Respiratory muscle strength: maximum inspiratory pressure, maximum expiratory pressure and sniff nasal pressure [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]
  • Sleep fragmentation as assessed by actigraphy [ Time Frame: 2 week perids from 4 and 10 weeks ] [ Designated as safety issue: No ]
  • Patient ventilator synchrony as measured by number of ineffective efforts [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2009
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00994552

Contacts
Contact: Katherine Brignall, MB ChB 0044 20 7188 7188 ext 88070 kate.brignall@gstt.nhs.uk
Contact: Patrick Murphy, MB BS 0044 20 71887188 ext 88070 patrick.murphy@gstt.nhs.uk

Locations
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
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
  More Information

No publications provided by Guy's and St Thomas' NHS Foundation Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karen Ignathian, Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00994552     History of Changes
Other Study ID Numbers: 09/H0802/3
Study First Received: October 13, 2009
Last Updated: October 13, 2009
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Neuromuscular Diseases
Obesity
Hypoventilation
Respiratory Insufficiency
Nervous System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on August 20, 2014