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
Recruitment status was Recruiting
Sponsor:
Guy's and St Thomas' NHS Foundation Trust
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
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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
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 May 19, 2013