Clinical trial NCT00994552: Comparison of Pressure Support and Pressure Control Ventilation in Chronic Respiratory Failure
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: COPD
Chest Wall Disease
Neuromuscular Disease
Obesity Hypoventilation
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2009-10-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Adherence to ventilation
timeFrame: 6 and 12 weeks
Secondary outcomes:
measure: Arterial blood gases
timeFrame: 6 and 12 weeks
measure: Health related quality of life as measured by CRQ and SRI
timeFrame: 6 and 12 weeks
measure: Breathlessness (MRC dyspnoea score)
timeFrame: 6 and 12 weeks
measure: Assessment of daytime vigilance and fatigue by the Epworth sleepiness score,Oxford sleep resistance test and the fatigue severity score.
timeFrame: 6 and 12 weeks
measure: Sleep comfort as assessed by a visual analogue scale
timeFrame: 6 and 12 weeks
measure: Spirometry: forced expiratory volume in 1s and forced vital capacity
timeFrame: 6 and 12 weeks
measure: Respiratory muscle strength: maximum inspiratory pressure, maximum expiratory pressure and sniff nasal pressure
timeFrame: 6 and 12 weeks
measure: Sleep fragmentation as assessed by actigraphy
timeFrame: 2 week perids from 4 and 10 weeks
measure: Patient ventilator synchrony as measured by number of ineffective efforts
timeFrame: 6 and 12 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
Study officials:
affiliation: Guys's and St Thomas' NHS foundation trust
name: A Davidson, MA, MD
role: STUDY_CHAIR
affiliation: Guy's and St Thomas' Foundation Trust
name: N Hart, MB BS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: K Brignall, MB ChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.