Cuff OverinflationNCT02109003
Efficiency of a Mechanical Device in Controlling Tracheal Cuff Pressure in Intubated Critically Ill Patients
A study testing Pressure easy® device in people with Cuff Overinflation and Cuff Underinflation, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
Despite intermittent control of tracheal cuff pressure using a manual manometer, cuff underinflation and overinflation frequently occur in critically ill patients, resulting in increased risk for microaspiration and tracheal ischemic lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cuff Overinflation, Cuff Underinflation
- What is being tested?
- Pressure easy® device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2014to Dec 2014
- 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
- Patients intubated in the ICU with a polyvinyl chloride (PVC) cuffed tracheal tube.
- Predicted duration of mechanical ventilation > or = 48h.
- Age > or = 18 years.
- Signed informed consent.
Who cannot join
- Anticipated duration of mechanical ventilation<48h after randomization.
- Tracheostomized patients.
- Patients with contraindication for semirecumbent position.
- Patients participating to another trial that might influence this study results.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Area de Críticos, Hospital de Sabadell, Corporación Sanitaria y Universitaria Parc Taulí
Sabadell, Barcelona, 08208
About this study
Official title: Efficiency of PressureEasy in Controlling Tracheal Cuff Pressure in Intubated Critically Ill Patients
Despite intermittent control of tracheal cuff pressure using a manual manometer, cuff underinflation and overinflation frequently occur in critically ill patients, resulting in increased risk for microaspiration and tracheal ischemic lesions.
Read the detailed description
The aim of this study is to determine the efficiency of Pressure easy® device (Smiths medical cuff pressure controller) in continuous control of tracheal cuff pressure.
- Conditions
- Cuff Overinflation, Cuff Underinflation
- Being tested
- Pressure easy® device, Manual control of Pcuff followed by continuous control.
- Keywords
- tracheal cuff, cuff overinflation, cuff underinflation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure easy® deviceDevice
Also called Pressure easy® device (Smiths medical cuff pressure controller)
Continuous control of tracheal cuff pressure using a mechanical device for 24h followed by manual control of cuff pressure using a manometer.
Manual control of Pcuff followed by continuous control.Device
Control 24h with manual control using a manometer followed by 24h of continuous control using a mechanical device.
| Study group | Role | What they receive |
|---|---|---|
| Continuous control of Pcuff followed by manual control | Experimental | Patients receive continuous control of cuff pressure with Pressure easy® device for 24h, followed by discontinuous control (every 4 hours) with a manual manometer for 24 h. Receives: Device: Pressure easy® device |
| Manual control of Pcuff followed by continuous control. | Active comparator | Patients receive the reverse sequence (manual control followed by continuous control of Pcuff) Receives: Device: Manual control of Pcuff followed by continuous control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of recording time spent with cuff overinflation or underinflation
Continuous recording of cuff pressure will be performed during two 24-h periods (with or without Pressure easy® device)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2014
- Study completionDec 2014
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 Cuff OverinflationStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Artigas Raventós, Corporacion Parc Tauli
- Investigators
- Andrey Rodriguez, MD, Principal investigator, Critical Care Unit. Hospital de Sabadell, Corporación Sanitaria y Universitaria Parc Taulí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109003
- Sponsor's protocol ID
- EPREI
- Status last verified
- May 2015
- First submitted
- 7 Apr 2014
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Nseir S, Rodriguez A, Saludes P, De Jonckheere J, Valles J, Artigas A, Martin-Loeches I. Efficiency of a mechanical device in controlling tracheal cuff pressure in intubated critically ill patients: a randomized controlled study. Ann Intensive Care. 2015 Dec;5(1):54. doi: 10.1186/s13613-015-0054-z. Epub 2015 Jun 2.
PubMed 26059205
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of PressureEasy in Controlling Tracheal Cuff Pressure in Intubated Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02109003
- Acronym / sponsor ID
- EPREI
- Conditions
- Cuff Overinflation, Cuff Underinflation
- Keywords
- tracheal cuff, cuff overinflation, cuff underinflation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Apr 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.
Despite intermittent control of tracheal cuff pressure using a manual manometer, cuff underinflation and overinflation frequently occur in critically ill patients, resulting in increased risk for microaspiration and tracheal ischemic lesions.
Detailed description
The aim of this study is to determine the efficiency of Pressure easy® device (Smiths medical cuff pressure controller) in continuous control of tracheal cuff pressure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous control of Pcuff followed by manual control | Experimental | Device: Pressure easy® devicePatients receive continuous control of cuff pressure with Pressure easy® device for 24h, followed by discontinuous control (every 4 hours) with a manual manometer for 24 h. |
| Manual control of Pcuff followed by continuous control. | Active comparator | Device: Manual control of Pcuff followed by continuous control.Patients receive the reverse sequence (manual control followed by continuous control of Pcuff) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients intubated in the ICU with a polyvinyl chloride (PVC) cuffed tracheal tube.
- Predicted duration of mechanical ventilation > or = 48h.
- Age > or = 18 years.
- Signed informed consent.
Key exclusion criteria (4 listed)
- Anticipated duration of mechanical ventilation<48h after randomization.
- Tracheostomized patients.
- Patients with contraindication for semirecumbent position.
- Patients participating to another trial that might influence this study results.
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 |
|---|---|---|
| Pressure easy® deviceAlso: Pressure easy® device (Smiths medical cuff pressure controller)Continuous control of tracheal cuff pressure using a mechanical device for 24h followed by manual control of cuff pressure using a manometer. | Device | Continuous control of Pcuff followed by manual control |
| Manual control of Pcuff followed by continuous control.Control 24h with manual control using a manometer followed by 24h of continuous control using a mechanical device. | Device | Manual control of Pcuff followed by continuous control. |
Primary outcome
Percentage of recording time spent with cuff overinflation or underinflation
Time frame: 48 hours
Continuous recording of cuff pressure will be performed during two 24-h periods (with or without Pressure easy® device)
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 2 Jun 2015.
- Derived from this study: PubMed 26059205Nseir S, Rodriguez A, Saludes P, De Jonckheere J, Valles J, Artigas A, Martin-Loeches I. Efficiency of a mechanical device in controlling tracheal cuff pressure in intubated critically ill patients: a randomized controlled study. Ann Intensive Care. 2015 Dec;5(1):54. doi: 10.1186/s13613-015-0054-z. Epub 2015 Jun 2.
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.
Andrey Rodriguez, MD principal investigator
Critical Care Unit. Hospital de Sabadell, Corporación Sanitaria y Universitaria Parc Taulí
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressure easy® device in people with Cuff Overinflation and Cuff Underinflation, run by Corporacion Parc Tauli at 1 site in Spain.
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 4 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 2 Jun 2015. 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 Spain. 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?
Percentage of recording time spent with cuff overinflation or underinflation (time frame: 48 hours). 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 NCT02109003, 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 2 Jun 2015.