Chronic Respiratory FailureINSPIRERNCT05796297
Clinical Impact of Patient-ventilator Asynchrony
An observational study of Chronic Respiratory Failure and Non-invasive Ventilation, run by Nantes University Hospital at 1 site in France.
Trial summary
The investigator wish to carry out this study to explore the link between patient-ventilator asynchrony with the efficiency and tolerance of NIV but also the quality of life in patients with chronic respiratory failure on long-term ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Respiratory Failure, Non-invasive Ventilation, Asynchrony Between Patient and Ventilator
- What is being tested?
- Transcutaneous Capnography
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2023to 14 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patient with chronic respiratory insufficiency fitted with long-term NIV, whatever the reason for the chronic respiratory insufficiency. A transcutaneous capnography within 15 days preceding the follow-up consultation and obtaining the SIM card containing the machine data will be required to be included in the study.
Who may be able to join
- Women and Men aged of at least 18 years old.
- NIV equipment since 6 months ( at least)
- Chronic respiratory failure requiring NIV equipment defined by clinical symptoms (asthenia, excessive daytime sleepiness, headache, dyspnea) and:
- In case of obstructive diseases :
- Daytime hypercapnia (PaCO2 > 55 mmHg) or Daytime hypercapnia between 50-54 mmHg associated with nocturnal desaturations (at least 5 min below 88% saturation) or episodes of frequent hypercapnic exacerbations (at least 2 over the last 12 months)
- In case of restrictive diseases :
Show all 10Show fewer
- Daytime hypercapnia (PaCO2>6 kPa (kilopascal) or 45 mm Hg) or Nocturnal desaturation (SaO2 < 88%) for at least 5 minutes without obstructive sleep apnea syndrome (OSAS) found or Marker of progression of neuromuscular damage (Maximum inspiratory pressure < 60 cm H2O and forced vital capacity (FVC) less than 50% of theory)
- NIV's start from at least 6 months.
- Patient who did not object to being included in the study.
- Patient in stable condition without exacerbation (for at least 3 months)
Who cannot join
- Minor patient
- Pregnant or breastfeeding women
- Adult patient subject to enhanced protection, deprived of liberty by judicial or administrative decision.
- Patient who is physically or psychologically unable to follow the protocol in an informed manner.
- Patient with chronic respiratory failure requiring mechanical ventilation by tracheotomy
- Patient having changed center or service provider (data not available).
- Patient who objected to being included in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Impact of Patient Ventilator Asynchrony in Patients With Chronic Respiratory Failure on Long-term Ventilation : a Prospective, Monocentric, Open-label Epidemiological Study
The investigator wish to carry out this study to explore the link between patient-ventilator asynchrony with the efficiency and tolerance of NIV but also the quality of life in patients with chronic respiratory failure on long-term ventilation.
Read the detailed description
Chronic respiratory failure (CRF) is an advanced stage of many respiratory diseases marked by an inability of the respiratory system to ensure vital gas exchange. It affects approximately 3.6 million people in France.
Non-invasive ventilation (NIV) remains the reference treatment in hypercapnic respiratory failure because it reduces inspiratory muscles's work and promotes alveolar ventilation.
The establishment of the NIV is carried out most of the time following an episode of acute decompensation revealing an underlying CRF. It is carried out and supervised in hospital departments to optimize the understanding and adherence of the patient to his illness and his treatment.
Thus, monitoring is a key to measure the tolerance and effectiveness of ventilation. Classically, it is based on multi-year medical consultations, blood gases and nocturnal oximetry. In recent years, the reading of detailed data from software integrated into NIV machines has been increasingly used in current practice in association with the monitoring tools already recommended. It provides additional detailed information on compliance, leaks, apnea-hypopnea index (AHI), obstructive events and asynchrony between the patient and their ventilator.
Many patient-ventilator asynchronies have been described in studies with a negative impact on the quality of ventilation, the quality of sleep under NIV and an increased risk of mortality. However, not all asynchronies have the same consequences and are not all felt by the patient
- Conditions
- Chronic Respiratory Failure, Non-invasive Ventilation, Asynchrony Between Patient and Ventilator, Efficacy and Tolerance of Non-invasive Ventilation, Clinical Repercussions of the Various Patient-ventilator Asynchronies
- Being tested
- Transcutaneous Capnography
- Keywords
- Tolerance, Efficiency, Patient ventilator asynchrony, NIV
- Medical subject headings
- Patient-Ventilator Asynchrony
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous CapnographyDevice
Transcutaneous Capnography will be realized at patient home to monitoring nocturnal concentration of carbon dioxide during nocturnal sleeping ventilation
| Study group | Role | What they receive |
|---|---|---|
| Patient with significant patient ventilator asynchrony | Active Comparator Receives: Device: Transcutaneous Capnography | |
| Patient without significant patient ventilator asynchrony | Active Comparator Receives: Device: Transcutaneous Capnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilation's efficiency/tolerance
Presence of a significant rate of patient-ventilator asynchrony when reading the ventilation curves of the NIV machine data.
Measured: Up to 14 days
Secondary outcomes (2)
Estimation of quality of life with non-invasive ventilation
Estimation of perceived quality of life through the S3-Non Invasive Ventilation questionnaire (scale from 0 to 4 ; 0 being the worst outcome)
Measured: Up to 14 days
Estimation of quality of sleep with non-invasive ventilation
Estimation of perceived quality of sleep through the Epworth sleepiness scale (scale from 0 to 3 ; 3 being the worst outcome)
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Jun 2023
- Primary completion14 Apr 2024
- Study completion14 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JAFFRE, PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796297
- Sponsor's protocol ID
- RC23_0099
- Acronym
- INSPIRER
- Status last verified
- Mar 2025
- First submitted
- 8 Mar 2023
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of Patient Ventilator Asynchrony in Patients With Chronic Respiratory Failure on Long-term Ventilation : a Prospective, Monocentric, Open-label Epidemiological Study
- ClinicalTrials.gov ID
- NCT05796297
- Acronym / sponsor ID
- INSPIRER / RC23_0099
- Conditions
- Chronic Respiratory Failure, Non-invasive Ventilation, Asynchrony Between Patient and Ventilator, Efficacy and Tolerance of Non-invasive Ventilation, Clinical Repercussions of the Various Patient-ventilator Asynchronies
- Keywords
- Tolerance, Efficiency, Patient ventilator asynchrony, NIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 14 Apr 2024 (actual)
- Study completion
- 14 Apr 2024 (actual)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigator wish to carry out this study to explore the link between patient-ventilator asynchrony with the efficiency and tolerance of NIV but also the quality of life in patients with chronic respiratory failure on long-term ventilation.
Detailed description
Chronic respiratory failure (CRF) is an advanced stage of many respiratory diseases marked by an inability of the respiratory system to ensure vital gas exchange. It affects approximately 3.6 million people in France.
Non-invasive ventilation (NIV) remains the reference treatment in hypercapnic respiratory failure because it reduces inspiratory muscles's work and promotes alveolar ventilation.
The establishment of the NIV is carried out most of the time following an episode of acute decompensation revealing an underlying CRF. It is carried out and supervised in hospital departments to optimize the understanding and adherence of the patient to his illness and his treatment.
Thus, monitoring is a key to measure the tolerance and effectiveness of ventilation. Classically, it is based on multi-year medical consultations, blood gases and nocturnal oximetry. In recent years, the reading of detailed data from software integrated into NIV machines has been increasingly used in current practice in association with the monitoring tools already recommended. It provides additional detailed information on compliance, leaks, apnea-hypopnea index (AHI), obstructive events and asynchrony between the patient and their ventilator.
Many patient-ventilator asynchronies have been described in studies with a negative impact on the quality of ventilation, the quality of sleep under NIV and an increased risk of mortality. However, not all asynchronies have the same consequences and are not all felt by the patient
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with significant patient ventilator asynchrony | – | Device: Transcutaneous CapnographyActive Comparator |
| Patient without significant patient ventilator asynchrony | – | Device: Transcutaneous CapnographyActive Comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient with chronic respiratory insufficiency fitted with long-term NIV, whatever the reason for the chronic respiratory insufficiency. A transcutaneous capnography within 15 days preceding the follow-up consultation and obtaining the SIM card containing the machine data will be required to be included in the study.
Key inclusion criteria (10 listed)
- Women and Men aged of at least 18 years old.
- NIV equipment since 6 months ( at least)
- Chronic respiratory failure requiring NIV equipment defined by clinical symptoms (asthenia, excessive daytime sleepiness, headache, dyspnea) and:
- Daytime hypercapnia (PaCO2 > 55 mmHg) or Daytime hypercapnia between 50-54 mmHg associated with nocturnal desaturations (at least 5 min below 88% saturation) or episodes of frequent hypercapnic exacerbations (at least 2 over the last 12 months)
- Daytime hypercapnia (PaCO2>6 kPa (kilopascal) or 45 mm Hg) or Nocturnal desaturation (SaO2 < 88%) for at least 5 minutes without obstructive sleep apnea syndrome (OSAS) found or Marker of progression of neuromuscular damage (Maximum inspiratory pressure < 60 cm H2O and forced vital capacity (FVC) less than 50% of theory)
Key exclusion criteria (7 listed)
- Minor patient
- Pregnant or breastfeeding women
- Adult patient subject to enhanced protection, deprived of liberty by judicial or administrative decision.
- Patient who is physically or psychologically unable to follow the protocol in an informed manner.
- Patient with chronic respiratory failure requiring mechanical ventilation by tracheotomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous CapnographyTranscutaneous Capnography will be realized at patient home to monitoring nocturnal concentration of carbon dioxide during nocturnal sleeping ventilation | Device | Patient with significant patient ventilator asynchrony, Patient without significant patient ventilator asynchrony |
Primary outcome
Ventilation's efficiency/tolerance
Time frame: Up to 14 days
Presence of a significant rate of patient-ventilator asynchrony when reading the ventilation curves of the NIV machine data.
2 secondary outcomes
Estimation of quality of life with non-invasive ventilation
Time frame: Up to 14 days
Estimation of quality of sleep with non-invasive ventilation
Time frame: Up to 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JAFFRE, PH principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Respiratory Failure and Non-invasive Ventilation, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilation's efficiency/tolerance (time frame: Up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.