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

COPD Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00994552
• Other study ID #: 09/H0802/3
• Status: Recruiting
• Phase: Phase 4
• First received: October 13, 2009
• Last updated: October 13, 2009
• Start date: August 2009

Study information

• Verified date: October 2009
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Katherine Brignall, MB ChB
• Phone: 0044 20 7188 7188
• Email: kate.brignall[@]gstt.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chest Wall Disease
• COPD
• Hypoventilation
• Neuromuscular Disease
• Neuromuscular Diseases
• Obesity Hypoventilation
• Respiratory Insufficiency

Intervention

Other:
• Pressure support ventilation
Pressure support ventilation
• Pressure control ventilation
Pressure control ventilation

Locations

Country	Name	City	State
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to ventilation		6 and 12 weeks	No
Secondary	Arterial blood gases		6 and 12 weeks	No
Secondary	Health related quality of life as measured by CRQ and SRI		6 and 12 weeks	No
Secondary	Breathlessness (MRC dyspnoea score)		6 and 12 weeks	No
Secondary	Assessment of daytime vigilance and fatigue by the Epworth sleepiness score,Oxford sleep resistance test and the fatigue severity score.		6 and 12 weeks	No
Secondary	Sleep comfort as assessed by a visual analogue scale		6 and 12 weeks	No
Secondary	Spirometry: forced expiratory volume in 1s and forced vital capacity		6 and 12 weeks	No
Secondary	Respiratory muscle strength: maximum inspiratory pressure, maximum expiratory pressure and sniff nasal pressure		6 and 12 weeks	No
Secondary	Sleep fragmentation as assessed by actigraphy		2 week perids from 4 and 10 weeks	No
Secondary	Patient ventilator synchrony as measured by number of ineffective efforts		6 and 12 weeks	No