Intubation ComplicationsNCT01550978
Evaluation of the Safety and Efficacy of the AnapnoGuard 100 System
A study testing AnapnoGuard 100 System in people with Intubation Complications, run by Hospitech Respiration at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate the safety of using the AnapnoGuard 100 system during the course of mechanical ventilation and intubation of critical care patients in Intensive Care Unit. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Intubation Complications
- What is being tested?
- AnapnoGuard 100 System
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2012to May 2015
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 21 (men and women);
- Patient is admitted to ICU and expected to receive mechanical ventilation for more than 12 hours
- Absence of clear signs of pneumonia and lung contusion on chest X ray;
- For study patients, connection of the ETT to the AnapnoGuard system less than 6 hours from intubation initiation;
- No fever or fever from a known non chest/lung origin;
Who cannot join
- Patients who had been treated with mechanical ventilation during the last 3 months;
- Patients with facial, oropharyngeal or neck trauma
- BMI > 40
- Pregnant women
- Patients ventilated in prone position
- Difficult intubation (defined as more than 3 intubation attempts)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safety of Using the AnapnoGuard 100 System in Intubated Critical Care Patients
The purpose of this study is to evaluate the safety of using the AnapnoGuard 100 system during the course of mechanical ventilation and intubation of critical care patients in Intensive Care Unit.
- Conditions
- Intubation Complications
- Being tested
- AnapnoGuard 100 System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnapnoGuard 100 SystemDevice
AnapnoGuard™ 100 Respiratory Guard System is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube's cuff.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Patients intubated with AnapnoGuard EndoTracheal Tube and connected to the AnapnoGuard 100 Control System Receives: Device: AnapnoGuard 100 System |
| Control Group | No intervention | Patients intubated with the Standard of Care EndoTracheal Tube and Connected to a Suction Regulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of AE (adverse events) and SAE (serious adverse events)
Measured: participants will be followed for the entire duration of intubation (an expected average of 8 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionMay 2015
- Study completionMay 2015
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 Intubation ComplicationsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospitech Respiration
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Massimo Antonelli, Prof., Principal investigator, Director of General ICU and Institute of Anesthesiology and Intensive Care, Policlinico Universitario A. Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550978
- Sponsor's protocol ID
- HST-AG-04
- Status last verified
- Feb 2016
- First submitted
- 21 Feb 2012
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
De Pascale G, Pennisi MA, Vallecoccia MS, Bello G, Maviglia R, Montini L, Di Gravio V, Cutuli SL, Conti G, Antonelli M. CO2 driven endotracheal tube cuff control in critically ill patients: A randomized controlled study. PLoS One. 2017 May 11;12(5):e0175476. doi: 10.1371/journal.pone.0175476. eCollection 2017.
PubMed 28493877
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety of Using the AnapnoGuard 100 System in Intubated Critical Care Patients
- ClinicalTrials.gov ID
- NCT01550978
- Acronym / sponsor ID
- HST-AG-04
- Conditions
- Intubation Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospitech RespirationIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 12 Mar 2012 (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 evaluate the safety of using the AnapnoGuard 100 system during the course of mechanical ventilation and intubation of critical care patients in Intensive Care Unit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Device: AnapnoGuard 100 SystemPatients intubated with AnapnoGuard EndoTracheal Tube and connected to the AnapnoGuard 100 Control System |
| Control Group | No intervention | –Patients intubated with the Standard of Care EndoTracheal Tube and Connected to a Suction Regulator |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age above 21 (men and women);
- Patient is admitted to ICU and expected to receive mechanical ventilation for more than 12 hours
- Absence of clear signs of pneumonia and lung contusion on chest X ray;
- For study patients, connection of the ETT to the AnapnoGuard system less than 6 hours from intubation initiation;
- No fever or fever from a known non chest/lung origin;
Key exclusion criteria (6 listed)
- Patients who had been treated with mechanical ventilation during the last 3 months;
- Patients with facial, oropharyngeal or neck trauma
- BMI > 40
- Pregnant women
- Patients ventilated in prone position
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 |
|---|---|---|
| AnapnoGuard 100 SystemAnapnoGuard™ 100 Respiratory Guard System is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube's cuff. | Device | Study Group |
Primary outcome
Rate of AE (adverse events) and SAE (serious adverse events)
Time frame: participants will be followed for the entire duration of intubation (an expected average of 8 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 19 Feb 2016.
- Derived from this study: PubMed 28493877De Pascale G, Pennisi MA, Vallecoccia MS, Bello G, Maviglia R, Montini L, Di Gravio V, Cutuli SL, Conti G, Antonelli M. CO2 driven endotracheal tube cuff control in critically ill patients: A randomized controlled study. PLoS One. 2017 May 11;12(5):e0175476. doi: 10.1371/journal.pone.0175476. eCollection 2017.
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The ED-AWARENESS-2 Trial
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Cardiovascular History and Hemodynamic Complications After Intubation in ICU
Hemodynamic Complications
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Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
Postoperative Pulmonary Complications
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Establish Whether Hyperangulated Videolaryngoscopy (HAVL) Can be Used to Facilitate Tracheal Intubation Effectively and Safely in Unselected Adult Patients; Describe the Population in Whom HAVL Fails to Facilitate Tracheal Intubation Successfully, Identifying Any Contributory Characteristics.
Intubation Skill, Intubation Complications
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.
Massimo Antonelli, Prof. principal investigator
Director of General ICU and Institute of Anesthesiology and Intensive Care, Policlinico Universitario A. Gemelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AnapnoGuard 100 System in people with Intubation Complications, run by Hospitech Respiration 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 5 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 19 Feb 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?
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?
Rate of AE (adverse events) and SAE (serious adverse events) (time frame: participants will be followed for the entire duration of intubation (an expected average of 8 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 NCT01550978, 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 19 Feb 2016.