NCT01174316

Brief Summary

The aim of the study is to compare the efficacy and tolerance of autotitrating non-invasive ventilation (NIV) versus standard NIV in patients admitted to hospital with acute exacerbation of chronic respiratory failure. The investigators hypothesise that autotitrating NIV will ventilate patients with acute exacerbations of chronic respiratory failure as effectively as standard NIV.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 3, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2011

Completed
Last Updated

April 19, 2021

Status Verified

April 1, 2021

Enrollment Period

7 months

First QC Date

August 2, 2010

Last Update Submit

April 14, 2021

Conditions

Respiratory FailureNeuromuscular DiseaseChest Wall DisorderChronic Obstructive Pulmonary DiseaseObesity Hypoventilation Syndrome

Keywords

Acute exacerbationRespiratory insufficiencyRespiratory failureHypercapniaHypoventilationSleepHypoxiaTitrationNon Invasive Ventilation

Outcome Measures

Primary Outcomes (1)

  • pH at 1+ hour

    pH of arterial blood after 1 hour of treatment with non-invasive ventialtion compared baseline value

    1 hour

Secondary Outcomes (8)

  • pH at 4+ hours

    4+ hours of NIV treatment

  • Respiratory Rate at 1+ hour

    1+ hour of NIV treatment

  • Respiratory rate at 4+ hours

    4+ hours of NIV treatment

  • overnight mean transcutaneous carbon dioxide

    24 hours

  • PaCO2 at 1+ hours

    1+ hours of NIV treatment

  • +3 more secondary outcomes

Study Arms (2)

autotitrating NIV

EXPERIMENTAL

approximately 24 hours using autotitrating non-invasive ventilation for as many hours as possible whilst an inpatient in hospital

Device: AutoVPAP™

Standard non-invasive ventilation

ACTIVE COMPARATOR

approximately 24 hours using standard non-invasive ventilation for as many hours as possible whilst an inpatient in hospital.

Device: VPAPIIIST-A™

Interventions

AutoVPAP™DEVICE

Automatically titrated non-invasive ventilator, with target gross alveolar ventilation, end expiratory positive pressure, and back up respiratory rate determined by the clinician based on height and weight. The NIV must be used for as many hours as possible over the 24 hour period but breaks for meals, physiotherapy and bathroom are allowed.

Also known as: autotitrating variable positive airway pressure, autotitrating NIV, automatically titrating NIV
autotitrating NIV
VPAPIIIST-A™DEVICE

Standard non-invasive ventilator, with inspiratory and expiratory positive pressure determined by the healthcare professional. The NIV must be used for as many hours as possible over the 24 hour period but breaks for meals, physiotherapy and bathroom are allowed.

Also known as: standard NIV, standard non-invasive ventilator, variable positive airway pressure, VPAP
Standard non-invasive ventilation

Eligibility Criteria

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

You may qualify if:

  • patients admitted or transferred to Royal Brompton Hospital with acute exacerbation of chronic respiratory failure, or inpatients who suffer a deterioration in respiratory status, defined as 7.25 \< pH \< 7.35, PaCO2 \> 6.0kPa, and respiratory rate \> 20bpm

You may not qualify if:

  • \< 18 years old
  • pH \< 7.25
  • need for immediate intubation
  • uncontrolled cardiac failure
  • hypotensive (systolic blood pressure \< 90mmHg)
  • acute myocardial infarction
  • acute dysrhythmia
  • other system failure (e.g. acute renal failure, liver failure)
  • moderate or severe bulbar weakness
  • inability to understand rationale and/or consent form for study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Respiratory InsufficiencyNeuromuscular DiseasesPulmonary Disease, Chronic ObstructiveObesity Hypoventilation SyndromeHypercapniaHypoventilationHypoxia

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesNervous System DiseasesLung Diseases, ObstructiveLung DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSleep Apnea, ObstructiveSleep Apnea SyndromesApneaSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Anita Simonds, MD, FRCP

    Royal Brompton & Harefield Hospital NHS Trust

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2010

First Posted

August 3, 2010

Study Start

August 1, 2010

Primary Completion

March 1, 2011

Study Completion

May 10, 2011

Last Updated

April 19, 2021

Record last verified: 2021-04

Locations

GB(1)