In COPD patients with chronic hypercapnic respiratory failure, the prognosis is poor and the treatment with non invasive ventilation is actually well established. However the best mode of ventilation is not well known.
In severe COPD patients various disorders of respiratory mechanics result in insufficient ventilation, which can be life-threatening or create NIV discomfort. The main characteristic of these disorders is a cyclical closing of small airways that can limit an expiratory flow and provoked some fluctuations in flow curve. To our knowledge, the management of dynamic hyperinflation seems to play an important role in explaining the effect of the NIV. Few studies have examined the effects of the machine's adjustments on dynamic hyperinflation.
The main objective of this study is to analyze the impact of specific ventilatory modes supposed to reduce the dynamic hyperinflation on the hematosis, by studying transcutaneous pressure of carbon dioxide, in severe hypercapnic COPD patients ventilated by NIV. Two modes of ventilation will be compared. First one is an algorithmic mode developed by the company Löwenstein (AirTrap Control, Trigger Lockout and the Expiratory Pressure Ramp). The second one is a standard algorithmic mode, used in the same ventilator. These two ventilatory modes will be evaluated in each patient, during two consecutive nights in current living conditions at home.
Condition or disease | Intervention/treatment |
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Chronic Obstructive Pulmonary Disease Hypercapnia | Device: Non Invasive Ventilation |
Study Type : | Observational |
Estimated Enrollment : | 15 participants |
Observational Model: | Case-Crossover |
Time Perspective: | Prospective |
Official Title: | Non-invasive Home Ventilation in Patients With Severe Hypercapnic COPD: Standard Versus Löwenstein Mode of Management of Dynamic Hyperinflation; Effects on Hematosis and Sleep. |
Actual Study Start Date : | June 27, 2019 |
Estimated Primary Completion Date : | June 2020 |
Estimated Study Completion Date : | September 2020 |
Group/Cohort | Intervention/treatment |
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standard mode
after adjusting pressure and different modes of ventilation to each individual patient. Each one of them will receive NIV using Löwenstein mode during one night at home. Patients will be under transcutaneous PCO2 measurement and polysomnographic surveillance.
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Device: Non Invasive Ventilation
NIV using standard mode or Lowenstein mode
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Lowenstein mode
after adjusting pressure and different modes of ventilation to each individual patient. Each one of them will receive NIV without Löwenstein mode during one night at home. Patients will be under transcutaneous PCO2 measurement and polysomnographic surveillance.
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Device: Non Invasive Ventilation
NIV using standard mode or Lowenstein mode
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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contact: Frédéric Claudé | 0381669293 | fclaude@chu-besancon.fr | |
Contact: Lucie Laurent | 0381669293 | llaurent@chu-besancon.fr |
France | |
CHRU Jean Minjoz | Recruiting |
Besançon, Doubs, France, 25000 | |
Contact: Frédéric Claude fclaude@chu-besancon.fr |
Tracking Information | |||||
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First Submitted Date | April 29, 2019 | ||||
First Posted Date | May 2, 2019 | ||||
Last Update Posted Date | April 6, 2020 | ||||
Actual Study Start Date | June 27, 2019 | ||||
Estimated Primary Completion Date | June 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Mean carbon dioxide partial pressure-level during non invasive ventilation [ Time Frame: 2 nights ] Mean pCO2 level over night calculated using transcutaneous measurement of partial pressure of carbon dioxide under non invasive ventilation. Device : transcutaneous capnography (PtcCO2); SenTec Digital Monitoring System
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Original Primary Outcome Measures |
Mean Arterial carbon dioxide partial pressure-level during non invasive ventilation [ Time Frame: 2 nights ] Mean pCO2 level over night calculated using transcutaneous measurement of partial pressure of carbon dioxide under non invasive ventilation. Device : transcutaneous capnography (PtcCO2) SenTec Digital Monitoring System
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Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Non-invasive Home Ventilation in Patients With Severe Hypercapnic Chronic Obstructive Pulmonary Disease | ||||
Official Title | Non-invasive Home Ventilation in Patients With Severe Hypercapnic COPD: Standard Versus Löwenstein Mode of Management of Dynamic Hyperinflation; Effects on Hematosis and Sleep. | ||||
Brief Summary |
In COPD patients with chronic hypercapnic respiratory failure, the prognosis is poor and the treatment with non invasive ventilation is actually well established. However the best mode of ventilation is not well known. In severe COPD patients various disorders of respiratory mechanics result in insufficient ventilation, which can be life-threatening or create NIV discomfort. The main characteristic of these disorders is a cyclical closing of small airways that can limit an expiratory flow and provoked some fluctuations in flow curve. To our knowledge, the management of dynamic hyperinflation seems to play an important role in explaining the effect of the NIV. Few studies have examined the effects of the machine's adjustments on dynamic hyperinflation. The main objective of this study is to analyze the impact of specific ventilatory modes supposed to reduce the dynamic hyperinflation on the hematosis, by studying transcutaneous pressure of carbon dioxide, in severe hypercapnic COPD patients ventilated by NIV. Two modes of ventilation will be compared. First one is an algorithmic mode developed by the company Löwenstein (AirTrap Control, Trigger Lockout and the Expiratory Pressure Ramp). The second one is a standard algorithmic mode, used in the same ventilator. These two ventilatory modes will be evaluated in each patient, during two consecutive nights in current living conditions at home. |
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Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Case-Crossover Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Patients followed in the pneumology department of the Besançon university hospital. | ||||
Condition |
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Intervention | Device: Non Invasive Ventilation
NIV using standard mode or Lowenstein mode
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Unknown status | ||||
Estimated Enrollment |
15 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | September 2020 | ||||
Estimated Primary Completion Date | June 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Older Adult | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03934749 | ||||
Other Study ID Numbers | 2018-A02135-50 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Centre Hospitalier Universitaire de Besancon | ||||
Study Sponsor | Centre Hospitalier Universitaire de Besancon | ||||
Collaborators | Not Provided | ||||
Investigators | Not Provided | ||||
PRS Account | Centre Hospitalier Universitaire de Besancon | ||||
Verification Date | April 2019 |