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CompletedNCT03401463Updated Jul 31, 2018

Assesment of the Endotracheal Tube Cuff Pressure Values in ICU Pateints Before and After Training Seminar

An interventional study of traning seminar in Respiratory Tract Diseases, Respiratory Tract Infections and Pneumonia, Ventilator-Associated, sponsored by Jagiellonian University. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-31.

Sponsored by Jagiellonian University · Not applicable, Interventional, and Prevention

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Phase
Not applicable
Study type
Interventional
Enrollment
188
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Respiratory Tract Diseases
  • Respiratory Tract Infections
  • Pneumonia, Ventilator-Associated
  • Ventilator-Induced Lung Injury

Keywords

  • endotracheal tube cuff pressure
  • Ventilator-Induced Lung Injury
  • traning
03

In context

Respiratory Tract Diseases

410 studies on the registry are indexed under Respiratory Tract Diseases; 59 are open to participants now.

This study's enrollment of 188 is above the median of 117 across 316 interventional studies indexed under Respiratory Tract Diseases.

Browse Respiratory Tract Diseases studies →

Lead sponsor

Jagiellonian University is the lead sponsor of 161 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Mechanically ventilated patients intubated in a medical intensive care unit

Exclusion criteria

Exclusion Criteria:

  • Patient requiring prone positioning, tracheo-esophageal fistula, lung transplant and neutropenic patients
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
188 participants (actual)

Study arms

  • Active comparator
    once a day

    Cuff pressure checks once a day.

    Other: traning seminar

  • Active comparator
    three times a day

    Cuff pressure checks three times a day

    Other: traning seminar

Interventions

  • Othertraning seminar

    There will be provided 30 min training seminar on the function of endotracheal cuff and cuff pressure.

06

What researchers measure

Primary outcomes

  1. monitoring of cuff pressures

    The effectiveness of pressure monitoring in various time intervals

    Time frame: 1 year

Secondary outcomes

  1. preventing complications of incorrect pressure in tracheal cuff

    preventing of an VAP or airway damage

    Time frame: 5 years

07

Study locations

1 site
  • University Hospital
    Kraków, 31-501, Poland
08

References and documents

Individual participant data

Plan to share: Undecided — We are undecided on this point.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Jun 2018, 8 months.

Of 46 non-industry interventional studies with no phase under Respiratory Tract Diseases, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 74. This study's 8 months is below that.

Counting every sponsor, half of 52 studies reached it within 30 months; a quarter within 11 and three quarters within 74.

Respiratory Tract Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 3, 2018
First posted
Jan 17, 2018
StartActual
Oct 26, 2017
Primary completionActual
Jun 30, 2018
CompletionActual
Jul 5, 2018
Last update
Jul 31, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03401463
Responsible party
Tomasz Skladzien (MD PhD, Principal Investigator, Jagiellonian University) — Principal investigator
First posted
Jan 17, 2018
Start date
Oct 26, 2017
Primary completion
Jun 30, 2018
Completion
Jul 5, 2018
Last update
Jul 31, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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