Respiratory InsufficiencyPhase 4NCT00665119
Effects of Remifentanil on Respiratory Function in Mechanically Ventilated Patients
A Phase 4 study testing remifentanil in people with Respiratory Insufficiency and Respiration, Artificial, run by Fondazione Poliambulanza Istituto Ospedaliero at 1 site in Italy.
Trial summary
Sedation is widely used in mechanically ventilated patients. Propofol, benzodiazepines and opioids are the most used drugs. The study hypothesis is that sedation with remifentanil (an opioid drug) could improved respiratory pattern and effort in mechanically ventilated patients with rapid shallow breathing or high… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency, Respiration, Artificial, Conscious Sedation
- What is being tested?
- remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2008to Oct 2008
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pressure support ventilation or CPAP
- respiratory rate > 35.min-1
- respiratory rate/tidal volume > 105
Who cannot join
- vasoactive agents (dopamine lower than 5 mcg.kg-1.min-1 is not considered as vasoactive agent)
- body temperature > 38 °C
- Glasgow Coma Scale < 9
- FIO2 > 0.6
- PEEP > 10 cmH2O
- pH < 7.30
Trial locations and contacts
1 site in 1 country.
Italy1 site
Intensive Care Unit, Fondazione Poliambulanza Istituto Ospedaliero
Brescia, 25124
About this study
Official title: Effects of Remifentanil on Breathing Pattern, Respiratory Effort and Gas Exchange in Mechanically Ventilated Patients.
Sedation is widely used in mechanically ventilated patients. Propofol, benzodiazepines and opioids are the most used drugs. The study hypothesis is that sedation with remifentanil (an opioid drug) could improved respiratory pattern and effort in mechanically ventilated patients with rapid shallow breathing or high respiratory rate.
- Being tested
- remifentanil, placebo
- Keywords
- Respiratory Insufficiency, Respiration, Artificial, Remifentanil, Respiratory Mechanics, Work of Breathing
- Medical subject headings
- Respiratory Insufficiency, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remifentanilDrug
0.05 mcg.kg-1.min-1 for 30 minutes by continuous endovenous infusion
placeboDrug
NaCl 0.9 %
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Any patient alternatively receive both remifentanil and isotonic saline (placebo)infusion. The order of infusion is randomized. An interval of 30 minutes is planned between the two infusions. Receives: Drug: remifentanil; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
respiratory rate/tidal volume
Measured: before and after remifentanil infusion; before and after placebo infusion.
pressure-time product
Measured: before and after remifentanil infusion; before and after placebo infusion.
Secondary outcomes (5)
double product of respiratory system
Measured: before and after remifentanil infusion; before and after placebo infusion.
dynamic intrinsic PEEP
Measured: before and after remifentanil infusion; before and after placebo infusion.
adverse events
Measured: during all the study period
arterial pH
Measured: before and after remifentanil infusion; before and after placebo infusion.
level of sedation (RASS)
Measured: before and after remifentanil infusion; before and after placebo infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory InsufficiencyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Poliambulanza Istituto Ospedaliero
- Sponsor type
- University, hospital or other
- Investigators
- Giuseppe Natalini, MD, Principal investigator, Fondazione Poliambulanza Istituto Ospedaliero
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665119
- Sponsor's protocol ID
- FP-TIP-01
- Status last verified
- Dec 2008
- First submitted
- 18 Apr 2008
- Last updated
- 18 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Natalini G, Di Maio A, Rosano A, Ferretti P, Bertelli M, Bernardini A. Remifentanil improves breathing pattern and reduces inspiratory workload in tachypneic patients. Respir Care. 2011 Jun;56(6):827-33. doi: 10.4187/respcare.01014. Epub 2011 Feb 11.
PubMed 21333087
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remifentanil on Breathing Pattern, Respiratory Effort and Gas Exchange in Mechanically Ventilated Patients.
- ClinicalTrials.gov ID
- NCT00665119
- Acronym / sponsor ID
- FP-TIP-01
- Keywords
- Respiratory Insufficiency, Respiration, Artificial, Remifentanil, Respiratory Mechanics, Work of Breathing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Fondazione Poliambulanza Istituto OspedalieroUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 23 Apr 2008 (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.
Sedation is widely used in mechanically ventilated patients. Propofol, benzodiazepines and opioids are the most used drugs. The study hypothesis is that sedation with remifentanil (an opioid drug) could improved respiratory pattern and effort in mechanically ventilated patients with rapid shallow breathing or high respiratory rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: remifentanil, Drug: placeboAny patient alternatively receive both remifentanil and isotonic saline (placebo)infusion. The order of infusion is randomized. An interval of 30 minutes is planned between the two infusions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- pressure support ventilation or CPAP
- respiratory rate > 35.min-1
- respiratory rate/tidal volume > 105
Key exclusion criteria (6 listed)
- vasoactive agents (dopamine lower than 5 mcg.kg-1.min-1 is not considered as vasoactive agent)
- body temperature > 38 °C
- Glasgow Coma Scale < 9
- FIO2 > 0.6
- PEEP > 10 cmH2O
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 |
|---|---|---|
| remifentanil0.05 mcg.kg-1.min-1 for 30 minutes by continuous endovenous infusion | Drug | treatment |
| placeboNaCl 0.9 % | Drug | treatment |
Primary outcome
respiratory rate/tidal volume
Time frame: before and after remifentanil infusion; before and after placebo infusion.
pressure-time product
Time frame: before and after remifentanil infusion; before and after placebo infusion.
5 secondary outcomes
double product of respiratory system
Time frame: before and after remifentanil infusion; before and after placebo infusion.
dynamic intrinsic PEEP
Time frame: before and after remifentanil infusion; before and after placebo infusion.
adverse events
Time frame: during all the study period
arterial pH
Time frame: before and after remifentanil infusion; before and after placebo infusion.
level of sedation (RASS)
Time frame: before and after remifentanil infusion; before and after placebo infusion.
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 18 Dec 2008.
- Derived from this study: PubMed 21333087Natalini G, Di Maio A, Rosano A, Ferretti P, Bertelli M, Bernardini A. Remifentanil improves breathing pattern and reduces inspiratory workload in tachypneic patients. Respir Care. 2011 Jun;56(6):827-33. doi: 10.4187/respcare.01014. Epub 2011 Feb 11.
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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.
Giuseppe Natalini, MD principal investigator
Fondazione Poliambulanza Istituto Ospedaliero
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing remifentanil in people with Respiratory Insufficiency and Respiration, Artificial, run by Fondazione Poliambulanza Istituto Ospedaliero 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 3 inclusion and 6 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 18 Dec 2008. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
respiratory rate/tidal volume (time frame: before and after remifentanil infusion; before and after placebo infusion.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00665119, which also lists 1 linked publication.
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 18 Dec 2008.