Inadequate or Impaired Breathing Pattern or VentilationNCT01322659
Weaning Using Noninvasive Positive Pressure Ventilation by Means of Helmet in Patients With Acute Respiratory Failure
A study testing Helmet and Endotracheal tube in people with Inadequate or Impaired Breathing Pattern or Ventilation, run by University of Padova at 1 site in Italy.
Trial summary
The purpose of this study is to determine whether helmet is effective as device for noninvasive positive pressure ventilation in the weaning from mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inadequate or Impaired Breathing Pattern or Ventilation
- What is being tested?
- Helmet and Endotracheal tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2010to Jan 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- endotracheal mechanical ventilation for 48 hours or more for acute respiratory failure,
- patient ready to be weaned (steady respiratory and hemodynamic conditions for 24 hours),
- spontaneous breathing trial failure
- written informed consent obtained (patient or family)
Who cannot join
- respiratory and hemodynamic instability
- initial difficult intubation
- bronchial hypersecretion at the weaning time
- non cooperant patient
- recent history of upper gastro-intestinal surgery
- recent history of myocardial infarction
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether helmet is effective as device for noninvasive positive pressure ventilation in the weaning from mechanical ventilation.
Read the detailed description
The clinical efficacy of noninvasive positive pressure ventilation (NPPV) has been demonstrated. Interest has emerged in using NPPV to facilitate earlier removal of an endotracheal tube and decrease complications associated with prolonged intubation. Studies assessing NPPV in weaning are not enough and generally are performed with face masks as device for NPPV. This study assesses the efficacy of helmet as device for NPPV during weaning from mechanical ventilation in an ICU and compares this procedure with invasive mechanical complication (IMV) by analyzing respiratory parameters, clinical course and complications.
- Being tested
- Helmet, Endotracheal tube
- Keywords
- Mechanical ventilation, Weaning, Noninvasive ventilation, Acute respiratory failure, Helmet
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HelmetDevice
Weaning from mechanical ventilation with noninvasive positive pressure ventilation delivered by means of the helmet
Endotracheal tubeDevice
Weaning from mechanical ventilation with invasive mechanical ventilation delivered by means of the endotracheal tube
| Study group | Role | What they receive |
|---|---|---|
| Helmet NPPV | Active comparator | Weaning from mechanical ventilation with noninvasive positive pressure ventilation (NPPV)delivered by means of the helmet Receives: Device: Helmet |
| ETT IMV | Sham comparator | Weaning from mechanical ventilation with standard invasive mechanical ventilation (IMV) delivered by means of the endotracheal tube (ETT) Receives: Device: Endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weaning using noninvasive positive pressure ventilation by means of helmet in patients with acute respiratory failure
Main end-point defined as the weaning success/failure rate
Measured: 30 days
Secondary outcomes (1)
Weaning using noninvasive positive pressure ventilation by means of helmet in patients with acute respiratory failure
- Intubation duration
- Total duration of mechanical ventilation (endotracheal and non invasive)
- Weaning process duration
- Stress response evaluation
- Daily duration of ventilatory support
- ICU lentgh of stay
- Hospital lentgh of stay
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startMar 2010
- Primary completionJan 2013
- Study completionJan 2013
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 Inadequate or Impaired Breathing Pattern or VentilationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michele Carron, MD, Principal investigator, University medical hospital of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322659
- Sponsor's protocol ID
- 1926P
- Status last verified
- Mar 2011
- First submitted
- 21 Mar 2011
- Last updated
- 31 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Carron M, Rossi S, Carollo C, Ori C. Comparison of invasive and noninvasive positive pressure ventilation delivered by means of a helmet for weaning of patients from mechanical ventilation. J Crit Care. 2014 Aug;29(4):580-5. doi: 10.1016/j.jcrc.2014.03.035. Epub 2014 Apr 5.
PubMed 24793658
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weaning Using Noninvasive Positive Pressure Ventilation by Means of Helmet in Patients With Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT01322659
- Acronym / sponsor ID
- 1926P
- Keywords
- Mechanical ventilation, Weaning, Noninvasive ventilation, Acute respiratory failure, Helmet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 24 Mar 2011 (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.
The purpose of this study is to determine whether helmet is effective as device for noninvasive positive pressure ventilation in the weaning from mechanical ventilation.
Detailed description
The clinical efficacy of noninvasive positive pressure ventilation (NPPV) has been demonstrated. Interest has emerged in using NPPV to facilitate earlier removal of an endotracheal tube and decrease complications associated with prolonged intubation. Studies assessing NPPV in weaning are not enough and generally are performed with face masks as device for NPPV. This study assesses the efficacy of helmet as device for NPPV during weaning from mechanical ventilation in an ICU and compares this procedure with invasive mechanical complication (IMV) by analyzing respiratory parameters, clinical course and complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Helmet NPPV | Active comparator | Device: HelmetWeaning from mechanical ventilation with noninvasive positive pressure ventilation (NPPV)delivered by means of the helmet |
| ETT IMV | Sham comparator | Device: Endotracheal tubeWeaning from mechanical ventilation with standard invasive mechanical ventilation (IMV) delivered by means of the endotracheal tube (ETT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- endotracheal mechanical ventilation for 48 hours or more for acute respiratory failure,
- patient ready to be weaned (steady respiratory and hemodynamic conditions for 24 hours),
- spontaneous breathing trial failure
- written informed consent obtained (patient or family)
Key exclusion criteria (6 listed)
- respiratory and hemodynamic instability
- initial difficult intubation
- bronchial hypersecretion at the weaning time
- non cooperant patient
- recent history of upper gastro-intestinal surgery
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 |
|---|---|---|
| HelmetWeaning from mechanical ventilation with noninvasive positive pressure ventilation delivered by means of the helmet | Device | Helmet NPPV |
| Endotracheal tubeWeaning from mechanical ventilation with invasive mechanical ventilation delivered by means of the endotracheal tube | Device | ETT IMV |
Primary outcome
Weaning using noninvasive positive pressure ventilation by means of helmet in patients with acute respiratory failure
Time frame: 30 days
Main end-point defined as the weaning success/failure rate
1 secondary outcome
Weaning using noninvasive positive pressure ventilation by means of helmet in patients with acute respiratory failure
Time frame: 180 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 31 Jan 2013.
- Derived from this study: PubMed 24793658Carron M, Rossi S, Carollo C, Ori C. Comparison of invasive and noninvasive positive pressure ventilation delivered by means of a helmet for weaning of patients from mechanical ventilation. J Crit Care. 2014 Aug;29(4):580-5. doi: 10.1016/j.jcrc.2014.03.035. Epub 2014 Apr 5.
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.
Michele Carron, MD principal investigator
University medical hospital of Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Helmet and Endotracheal tube in people with Inadequate or Impaired Breathing Pattern or Ventilation, run by University of Padova 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 4 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 31 Jan 2013. 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. Some participants in this study may receive a placebo. 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?
Weaning using noninvasive positive pressure ventilation by means of helmet in patients with acute respiratory failure (time frame: 30 days). 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 NCT01322659, 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 31 Jan 2013.