Respiratory Tract DiseasesNCT03401463
Assesment of the Endotracheal Tube Cuff Pressure Values in ICU Pateints Before and After Training Seminar
A study testing traning seminar in people with Respiratory Tract Diseases and Respiratory Tract Infections, run by Jagiellonian University at 1 site in Poland.
Trial summary
There is no accepted standard for the frequency of monitoring endotracheal tube cuff pressures (ETCP). the investigators plan on comparing two strategies for monitoring ETCP in mechanically ventilated patients. Nowadays ETCP is evaluated once every 24 hours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Tract Diseases, Respiratory Tract Infections, Pneumonia, Ventilator-Associated
- What is being tested?
- traning seminar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 sitePoland
- Study dates
- 26 Oct 2017to 5 Jul 2018
- 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
- Mechanically ventilated patients intubated in a medical intensive care unit
Who cannot join
- Patient requiring prone positioning, tracheo-esophageal fistula, lung transplant and neutropenic patients
Trial locations and contacts
1 site in 1 country.
About this study
There is no accepted standard for the frequency of monitoring endotracheal tube cuff pressures (ETCP). the investigators plan on comparing two strategies for monitoring ETCP in mechanically ventilated patients.
Nowadays ETCP is evaluated once every 24 hours. Next, the investigator want to conduct training for medical and nursing staff. After the training, ETCP will be measured every 8 hours.
The aim of the study is to prove that more frequent pressure control (3 times a day) reduces the occurrence of abnormal ETCP.
- Conditions
- Respiratory Tract Diseases, Respiratory Tract Infections, Pneumonia, Ventilator-Associated, Ventilator-Induced Lung Injury
- Being tested
- traning seminar
- Keywords
- endotracheal tube cuff pressure, Ventilator-Induced Lung Injury, traning
- Medical subject headings
- Respiratory Tract Diseases, Respiratory Tract Infections, Pneumonia, Ventilator-Associated, Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traning seminarOther
There will be provided 30 min training seminar on the function of endotracheal cuff and cuff pressure.
| Study group | Role | What they receive |
|---|---|---|
| once a day | Active comparator | Cuff pressure checks once a day. Receives: Other: traning seminar |
| three times a day | Active comparator | Cuff pressure checks three times a day Receives: Other: traning seminar |
What is being measured
The primary outcome is the main question the study is designed to answer.
monitoring of cuff pressures
The effectiveness of pressure monitoring in various time intervals
Measured: 1 year
Secondary outcomes (1)
preventing complications of incorrect pressure in tracheal cuff
preventing of an VAP or airway damage
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start26 Oct 2017
- Primary completion30 Jun 2018
- Study completion5 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract DiseasesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study will include patients staying in the intensive care unit, requiring ventilation of the artificial airways in the form of endotracheal or tracheostomy tube. Patients will be over 18 years of age.
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Skladzien, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03401463
- Sponsor's protocol ID
- 1072.6120.194.2017
- Status last verified
- Jul 2018
- First submitted
- 3 Jan 2018
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are undecided on this point.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment of the Endotracheal Tube Cuff Pressure Values in ICU Pateints Before and After Training Seminar
- ClinicalTrials.gov ID
- NCT03401463
- Acronym / sponsor ID
- 1072.6120.194.2017
- Conditions
- Respiratory Tract Diseases, Respiratory Tract Infections, Pneumonia, Ventilator-Associated, Ventilator-Induced Lung Injury
- Keywords
- endotracheal tube cuff pressure, Ventilator-Induced Lung Injury, traning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 26 Oct 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 5 Jul 2018 (actual)
- First posted
- 17 Jan 2018 (actual)
- 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.
There is no accepted standard for the frequency of monitoring endotracheal tube cuff pressures (ETCP). the investigators plan on comparing two strategies for monitoring ETCP in mechanically ventilated patients.
Nowadays ETCP is evaluated once every 24 hours. Next, the investigator want to conduct training for medical and nursing staff. After the training, ETCP will be measured every 8 hours.
The aim of the study is to prove that more frequent pressure control (3 times a day) reduces the occurrence of abnormal ETCP.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will include patients staying in the intensive care unit, requiring ventilation of the artificial airways in the form of endotracheal or tracheostomy tube. Patients will be over 18 years of age.
| Arm | Type | Receives |
|---|---|---|
| once a day | Active comparator | Other: traning seminarCuff pressure checks once a day. |
| three times a day | Active comparator | Other: traning seminarCuff pressure checks three times a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mechanically ventilated patients intubated in a medical intensive care unit
Key exclusion criteria (1 listed)
- Patient requiring prone positioning, tracheo-esophageal fistula, lung transplant and neutropenic patients
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 |
|---|---|---|
| traning seminarThere will be provided 30 min training seminar on the function of endotracheal cuff and cuff pressure. | Other | once a day, three times a day |
Primary outcome
monitoring of cuff pressures
Time frame: 1 year
The effectiveness of pressure monitoring in various time intervals
1 secondary outcome
preventing complications of incorrect pressure in tracheal cuff
Time frame: 5 years
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 Jul 2018.
- Individual participant dataSharing planned: Undecided. We are undecided on this point.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traning seminar in people with Respiratory Tract Diseases and Respiratory Tract Infections, run by Jagiellonian University at 1 site in Poland.
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 1 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: finished, as of the sponsor's last update on 31 Jul 2018. 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 Poland. 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?
monitoring of cuff pressures (time frame: 1 year). 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 31 Jul 2018; AzTrials last refreshed its copy on 8 Nov 2026.