NCT01986413

Brief Summary

Aim of this prospective randomized trial is to compare non invasive ventilation (NIV) with pressure control (BiPAP-ST) to volume assured pressure support (iVAPS) with regards to sleep quality and alveolar ventilation in patients with routine NIV initiation after COPD exacerbation. 20 patients with COPD and chronic hypercapnic respiratory failure will spent two nights on NIV, one with spontaneous timed pressure controlled bilevel ventilation (BiPAP-ST) and one with the advanced mode of intelligent volume assured pressure support (iVAPS). Patients will spend the treatment nights in randomized order under polysomnographic surveillance, including transcutaneous PCO2 measurement. Besides the number of arousals and PCO2 values over night the sleep quality will be judged with regards to especially adjusted respiratory event criteria like unintentional leaks, patient ventilator asynchrony, and decrease of ventilatory drive.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 18, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

March 24, 2015

Status Verified

March 1, 2015

Enrollment Period

10 months

First QC Date

November 11, 2013

Last Update Submit

March 23, 2015

Conditions

COPDChronic Hypercapnic Respiratory Failure

Keywords

COPDchronic hypercapnic respiratory failureNIVrespiratory eventsIVAPS

Outcome Measures

Primary Outcomes (1)

  • Number of respiratory events during non invasive ventilation

    Unintentional leak, patient ventilator asynchrony, decrease of ventilatory drive, Apnoea, Hypopnea

    2 nights

Secondary Outcomes (1)

  • Sleep efficiency

    2 nights

Other Outcomes (1)

  • mean PCO2-level during non invasive ventilation

    2 nights

Study Arms (2)

BIPAP ST

ACTIVE COMPARATOR

one night, NIV with pressure controlled ventilation (BIPAP ST) with individually titrated pressure parameters.

Device: pressure controlled ventilation BIPAP STDevice: NIV

IVAPS

EXPERIMENTAL

one night, NIV with volume assured pressure support (IVAPS).The pressure parameters will be adjusted according to the BIPAP pressure levels.

Device: volume assured pressure support IVAPSDevice: NIV

Interventions

pressure controlled ventilation BIPAP STDEVICE

spontaneous timed pressure controled bilevel ventilation

Also known as: Stellar™ 150, ResMed
BIPAP ST
volume assured pressure support IVAPSDEVICE

intelligent volume assured Pressure Support

Also known as: Stellar™ 150 with iVAPS
IVAPS
NIVDEVICE

Patients with COPD and chronic hypercapnic respiratory failure will spent two nights on NIV, one with spontaneous timed pressure controlled bilevel ventilation (BiPAP ST) and one with the advanced mode of intelligent volume assured pressure support (IVAPS). Patients will spend the treatment nights in randomized order under polysomnographic surveillance, including transcutaneous PCO2 measurement.

Also known as: Stellar™ 150, ResMed
BIPAP STIVAPS

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable respiratory insufficiency
  • Hypercapnia \>50 mmHG
  • Clinically required NIV
  • Capable of giving consent

You may not qualify if:

  • Existing ventilatory support
  • Invasive ventilation
  • Any other severe physical disease that requires immediate medical assistance
  • Acute hypercapnic decompensation with pH \<7.30 in routine BGA
  • Circumstances that doesn't allow mask ventilation (e.g. facial deformation)
  • Participation in a clinical trial within the last 4 weeks
  • Pregnancy or nursing period
  • Drug addiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helios Klinik Hagen

Hagen, North Rhine-Westphalia, 58091, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Georg Nilius, MD

    Helios Klinik Hagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med.

Study Record Dates

First Submitted

November 11, 2013

First Posted

November 18, 2013

Study Start

July 1, 2013

Primary Completion

May 1, 2014

Study Completion

June 1, 2014

Last Updated

March 24, 2015

Record last verified: 2015-03

Locations

DE(1)