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

October 13, 2009
October 13, 2009
August 2009
April 2010   (final data collection date for primary outcome measure)
Adherence to ventilation [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • COPD
  • Chest Wall Disease
  • Neuromuscular Disease
  • Obesity Hypoventilation
  • Other: Pressure support ventilation
    Pressure support ventilation
  • Other: Pressure control ventilation
    Pressure control ventilation
  • Active Comparator: Pressure support ventilation
    Pressure support ventilation
    Intervention: Other: Pressure support ventilation
  • Active Comparator: Pressure control ventilation
    Pressure control ventilation
    Intervention: Other: Pressure control ventilation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Not Provided
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
United Kingdom
 
NCT00994552
09/H0802/3
No
Karen Ignathian, Guy's and St Thomas' NHS Foundation Trust
Guy's and St Thomas' NHS Foundation Trust
Not Provided
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
Guy's and St Thomas' NHS Foundation Trust
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP