Acute Hypercapnic Respiratory FailureREMINCT02264626
Sedation During Noninvasive Ventilation (NIV)
A study testing Remifentanil in people with Acute Hypercapnic Respiratory Failure, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
In patients undergoing NIV for acute respiratory, lack of tolerance is one of the main reason of failure. This may result in a poor synchrony between the patient and the machine, leading to gross mismatching and potentially to an increased work of breathing. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Hypercapnic Respiratory Failure
- What is being tested?
- Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2014to Oct 2017
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ph<7,35 and PaCO2>50 mmHg with acute respiratory failure
- Signs of respiratory distress and poor synchrony with the ventilator as assessed on the ventilator screen and by looking patient own rate and ventilator recorded rate
Who cannot join
- Patients responding well to NIV and not showing signs of poor synchrony
Trial locations and contacts
1 site in 1 country.
stefano nava, md contact
Italy1 site, 1 recruiting
- Recruiting
San'Orsola Malpighi Hospital, Bologna ITALY
Bologna, 40138
Stefano Nava, MD, 051 6364017, stefano.nava@aosp.bo.it
Stefano Nava, MD
About this study
Official title: Effects of Remifentanil Based Sedation on Patient-ventilator Interaction, in Patients Undergoing Noninvasive Ventilation (NIV)
In patients undergoing NIV for acute respiratory, lack of tolerance is one of the main reason of failure.
This may result in a poor synchrony between the patient and the machine, leading to gross mismatching and potentially to an increased work of breathing.
The investigators aim to investigate whether in these patients poorly responding to NIV the use of a sedation protocol using remifentanil will lead to an improve patient-ventilator interaction and better compliance to NIV.
Read the detailed description
In patients undergoing NIV for acute respiratory, lack of tolerance is one of the main reason of failure.
This may result in a poor synchrony between the patient and the machine, leading to gross mismatching and potentially to an increased work of breathing.
The investigators aim to investigate whether in these patients poorly responding to NIV the use of a sedation protocol using remifentanil will lead to an improve patient-ventilator interaction and better compliance to NIV.
In this physiological study the investigators will study 15 patients at risk of failing NIV because of scarce tolerance and showing clinical signs of poor interaction with the ventilator.
Once the patient will be enrolled the investigators will record using the balloon-catheter technique the online measurement of respiratory mechanics, to assess the inspiratory muscle effort and the matching between the patient breathing pattern and that of the ventilator The investigators will also record the clinical success of sedation (i.e. need or not for endotracheal intubation)
- Conditions
- Acute Hypercapnic Respiratory Failure
- Being tested
- Remifentanil
- Keywords
- acute respiratory failure, noninvasive ventilation, sedation, patient/ventilator interaction
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Also called ultriva
infusion at a rate by 0.025 μg kg-1 min-1 every minute to a maximum of 0.15 μg kg-1 min-1.
| Study group | Role | What they receive |
|---|---|---|
| acutely ill patients | Experimental | administration of remifentanil at the infusion rate by 0.025 μg kg-1 min-1 to a maximum of 0.10 μg kg-1 min-1. Receives: Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient-ventilator interaction
patient-ventilator interaction will be assessed using the recording of respiratory mechanics to identify
Measured: one hour
matching of inspiratory timing
the patients inspiratory time vs ventilator inspiratory time
Measured: one hour
Wasted efforts
breaths unable to trigger the ventilator
Measured: one hour
Secondary outcomes (1)
NIV failure
failure will be defined as the need for intubation:
- gasping for air
- worsening of sensorium
- respiratory arrest
- retention of secretions and/ or death
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hypercapnic Respiratory FailureStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Stefano Nava, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- stefano nava, md, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02264626
- Sponsor's protocol ID
- 116/2014O
- Acronym
- REMI
- Status last verified
- Oct 2016
- First submitted
- 4 Oct 2014
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remifentanil Based Sedation on Patient-ventilator Interaction, in Patients Undergoing Noninvasive Ventilation (NIV)
- ClinicalTrials.gov ID
- NCT02264626
- Acronym / sponsor ID
- REMI / 116/2014O
- Conditions
- Acute Hypercapnic Respiratory Failure
- Keywords
- acute respiratory failure, noninvasive ventilation, sedation, patient/ventilator interaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 15 Oct 2014 (estimated)
- 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.
In patients undergoing NIV for acute respiratory, lack of tolerance is one of the main reason of failure.
This may result in a poor synchrony between the patient and the machine, leading to gross mismatching and potentially to an increased work of breathing.
The investigators aim to investigate whether in these patients poorly responding to NIV the use of a sedation protocol using remifentanil will lead to an improve patient-ventilator interaction and better compliance to NIV.
Detailed description
In patients undergoing NIV for acute respiratory, lack of tolerance is one of the main reason of failure.
This may result in a poor synchrony between the patient and the machine, leading to gross mismatching and potentially to an increased work of breathing.
The investigators aim to investigate whether in these patients poorly responding to NIV the use of a sedation protocol using remifentanil will lead to an improve patient-ventilator interaction and better compliance to NIV.
In this physiological study the investigators will study 15 patients at risk of failing NIV because of scarce tolerance and showing clinical signs of poor interaction with the ventilator.
Once the patient will be enrolled the investigators will record using the balloon-catheter technique the online measurement of respiratory mechanics, to assess the inspiratory muscle effort and the matching between the patient breathing pattern and that of the ventilator The investigators will also record the clinical success of sedation (i.e. need or not for endotracheal intubation)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acutely ill patients | Experimental | Drug: Remifentaniladministration of remifentanil at the infusion rate by 0.025 μg kg-1 min-1 to a maximum of 0.10 μg kg-1 min-1. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ph<7,35 and PaCO2>50 mmHg with acute respiratory failure
- Signs of respiratory distress and poor synchrony with the ventilator as assessed on the ventilator screen and by looking patient own rate and ventilator recorded rate
Key exclusion criteria (1 listed)
- Patients responding well to NIV and not showing signs of poor synchrony
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 |
|---|---|---|
| RemifentanilAlso: ultrivainfusion at a rate by 0.025 μg kg-1 min-1 every minute to a maximum of 0.15 μg kg-1 min-1. | Drug | acutely ill patients |
Primary outcome
patient-ventilator interaction
Time frame: one hour
patient-ventilator interaction will be assessed using the recording of respiratory mechanics to identify
matching of inspiratory timing
Time frame: one hour
the patients inspiratory time vs ventilator inspiratory time
Wasted efforts
Time frame: one hour
breaths unable to trigger the ventilator
1 secondary outcome
NIV failure
Time frame: one hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2016.
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Extracorporeal Carbon Dioxide Removal Plus Noninvasive Ventilation in Patients With COPD Not Eligible for Intubation
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
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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.
stefano nava, md contact
stefano nava, md principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remifentanil in people with Acute Hypercapnic Respiratory Failure, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Oct 2016. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact stefano nava, md (393333751828), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient-ventilator interaction (time frame: one hour). The study lists 3 primary outcomes in all. 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 11 Oct 2016.