NCT00994552

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Last Updated

October 14, 2009

Status Verified

October 1, 2009

Enrollment Period

8 months

First QC Date

October 13, 2009

Last Update Submit

October 13, 2009

Conditions

COPDChest Wall DiseaseNeuromuscular DiseaseObesity Hypoventilation

Outcome Measures

Primary Outcomes (1)

  • Adherence to ventilation

    6 and 12 weeks

Secondary Outcomes (9)

  • Arterial blood gases

    6 and 12 weeks

  • Health related quality of life as measured by CRQ and SRI

    6 and 12 weeks

  • Breathlessness (MRC dyspnoea score)

    6 and 12 weeks

  • Assessment of daytime vigilance and fatigue by the Epworth sleepiness score,Oxford sleep resistance test and the fatigue severity score.

    6 and 12 weeks

  • Sleep comfort as assessed by a visual analogue scale

    6 and 12 weeks

  • +4 more secondary outcomes

Study Arms (2)

Pressure support ventilation

ACTIVE COMPARATOR

Pressure support ventilation

Other: Pressure support ventilation

Pressure control ventilation

ACTIVE COMPARATOR

Pressure control ventilation

Other: Pressure control ventilation

Interventions

Pressure support ventilationOTHER

Pressure support ventilation

Pressure support ventilation
Pressure control ventilationOTHER

Pressure control ventilation

Pressure control ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

    PMID: 23271905DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveNeuromuscular Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNervous System Diseases

Study Officials

  • A Davidson, MA, MD

    Guys's and St Thomas' NHS foundation trust

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Brignall, MB ChB

CONTACT

0044 20 7188 7188kate.brignall@gstt.nhs.uk

Patrick Murphy, MB BS

CONTACT

0044 20 71887188patrick.murphy@gstt.nhs.uk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 13, 2009

First Posted

October 14, 2009

Study Start

August 1, 2009

Primary Completion

April 1, 2010

Last Updated

October 14, 2009

Record last verified: 2009-10

Locations

GB(1)