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

Primary Purpose

COPD, Chest Wall Disease, Neuromuscular Disease

Status
Unknown status
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Pressure support ventilation
Pressure control ventilation
Sponsored by
Guy's and St Thomas' NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Guy's and St Thomas' NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pressure support ventilation

Pressure control ventilation

Arm Description

Pressure support ventilation

Pressure control ventilation

Outcomes

Primary Outcome Measures

Adherence to ventilation

Secondary Outcome Measures

Arterial blood gases
Health related quality of life as measured by CRQ and SRI
Breathlessness (MRC dyspnoea score)
Assessment of daytime vigilance and fatigue by the Epworth sleepiness score,Oxford sleep resistance test and the fatigue severity score.
Sleep comfort as assessed by a visual analogue scale
Spirometry: forced expiratory volume in 1s and forced vital capacity
Respiratory muscle strength: maximum inspiratory pressure, maximum expiratory pressure and sniff nasal pressure
Sleep fragmentation as assessed by actigraphy
Patient ventilator synchrony as measured by number of ineffective efforts

Full Information

First Posted
October 13, 2009
Last Updated
October 13, 2009
Sponsor
Guy's and St Thomas' NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00994552
Brief Title
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

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Chest Wall Disease, Neuromuscular Disease, Obesity Hypoventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pressure support ventilation
Arm Type
Active Comparator
Arm Description
Pressure support ventilation
Arm Title
Pressure control ventilation
Arm Type
Active Comparator
Arm Description
Pressure control ventilation
Intervention Type
Other
Intervention Name(s)
Pressure support ventilation
Intervention Description
Pressure support ventilation
Intervention Type
Other
Intervention Name(s)
Pressure control ventilation
Intervention Description
Pressure control ventilation
Primary Outcome Measure Information:
Title
Adherence to ventilation
Time Frame
6 and 12 weeks
Secondary Outcome Measure Information:
Title
Arterial blood gases
Time Frame
6 and 12 weeks
Title
Health related quality of life as measured by CRQ and SRI
Time Frame
6 and 12 weeks
Title
Breathlessness (MRC dyspnoea score)
Time Frame
6 and 12 weeks
Title
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
Title
Sleep comfort as assessed by a visual analogue scale
Time Frame
6 and 12 weeks
Title
Spirometry: forced expiratory volume in 1s and forced vital capacity
Time Frame
6 and 12 weeks
Title
Respiratory muscle strength: maximum inspiratory pressure, maximum expiratory pressure and sniff nasal pressure
Time Frame
6 and 12 weeks
Title
Sleep fragmentation as assessed by actigraphy
Time Frame
2 week perids from 4 and 10 weeks
Title
Patient ventilator synchrony as measured by number of ineffective efforts
Time Frame
6 and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine Brignall, MB ChB
Phone
0044 20 7188 7188
Ext
88070
Email
kate.brignall@gstt.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Murphy, MB BS
Phone
0044 20 71887188
Ext
88070
Email
patrick.murphy@gstt.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A Davidson, MA, MD
Organizational Affiliation
Guys's and St Thomas' NHS foundation trust
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
N Hart, MB BS, PhD
Organizational Affiliation
Guy's and St Thomas' Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
K Brignall, MB ChB
Organizational Affiliation
Guy's and St Thomas' NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Ignathian
Phone
00 44 207188 7188
Ext
85731
First Name & Middle Initial & Last Name & Degree
Kate Brignall, MB BS

12. IPD Sharing Statement

Citations:
PubMed Identifier
23271905
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.
Results Reference
derived

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

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