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Pneumonia, Ventilator-AssociatedNCT02950519

Endotracheal Tube Cuff Pressures in Ventilated Patients

A study testing monitoring of cuff pressures in people with Pneumonia, Ventilator-Associated, run by Barnes-Jewish Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There is no accepted standard for the frequency of monitoring endotracheal tube cuff pressures (ETCP). Investigators plan on comparing two strategies for monitoring ETCP in mechanically ventilated patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pneumonia, Ventilator-Associated
What is being tested?
monitoring of cuff pressures
Could I receive a placebo?
No, everyone receives an active treatment
How many people
305 participants
Where
1 siteUnited States
Study dates
Oct 2016to Dec 2017
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, lung transplant and neutropenic patients

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Assessing Endotracheal Tube Cuff Pressures in Mechanically Ventilated Patients

There is no accepted standard for the frequency of monitoring endotracheal tube cuff pressures (ETCP). Investigators plan on comparing two strategies for monitoring ETCP in mechanically ventilated patients. The two strategies will be the currently employed practice at Barnes-Jewish Hospital (BJH) which requires ETCP to be assessed immediately after the endotracheal tube is placed and after any manipulation of the endotracheal tube to include repositioning, manipulation of the cuff volume, or presence of an audible leak. Investigator will compare this current practice to a more intensive monitoring of ETCP which is employed at some hospitals and includes the same elements as noted in the current practice plus monitoring ETCP every work shift (every 8 hours or three times per day).

Read the detailed description

There is no accepted standard for the frequency of monitoring endotracheal tube cuff pressures (ETCP). Investigator plans on comparing two strategies for monitoring ETCP in mechanically ventilated patients. The two strategies will be the currently employed practice at Barnes-Jewish Hospital (BJH) which requires ETCP to be assessed immediately after the endotracheal tube is placed and after any manipulation of the endotracheal tube to include repositioning, manipulation of the cuff volume, or presence of an audible leak. The alternate practice will be pre-scheduled as is performed at other hospitals and includes the same elements as noted in the current practice but also require monitoring ETCP a minimum of every work shift (every 8 hours or three times per day). The ETCP will be assessed using a standard manometer. The two practices will be compared by assessing patients assigned to odd and even beds in the medical ICU (8400 ICU) with alternate methods. Specifically, patients in odd numbered rooms will have ETCP checked per the current Barnes-Jewish practice and those in even rooms having the additional checks of ETCP performed immediately following intubation as well as every shift and when when assessed required by respiratory therapist. It is important to note that the respiratory therapists performing ETCP assessments are simply performing a routine 2- 3 minute task (per cuff pressure measurement) while taking care of patients on mechanical ventilation.

Our hypothesis is that increased monitoring frequency of ETCP will not result in a decrease in the duration of mechanical ventilation for patients admitted to the medical intensive care unit (ICU) of BJH or a reduction in ventilator-associated events.

Currently there is no accepted gold standard for the frequency of monitoring ETCP. There are widely different strategies reported for monitoring ETCP to include continuous monitoring. The goal of ETCP monitoring is to maintain the ETCP between 20-30 cmH2O in order to minimize cuff leaks and pressure injury to the tracheal mucosa. It is known that 20 to 30% of the time the ETCP may deviate above or below this threshold. However, the impact of such deviation on clinical outcomes is not well described in the medical literature. The two most common methods for assessing ETCP is the use of a manometer and/or setting a minimal leak, with the former being the most accepted method. However, the optimal frequency for conducting manometric monitoring of ETCP is unknown. One recent study suggests that the act of measuring ETCP frequently in order to achieve a desired pressure level results in the removal of air from the cuff and can result in under inflation of the cuff. However, a recent animal study suggests that the material used to manufacture the endotracheal tube cuff may play a more important role in determining the presence or absence of mucosal injury, with polyurethane being better than polyvinylchloride. The main problem with these studies is the failure to assess clinical outcomes at the bedside with the use of various strategies to maintain an appropriate endotracheal tube cuff seal. A recent survey of intensivists in Queensland Australia and accompanying systematic literature review made the following conclusions regarding ETCP monitoring: "Twenty-eight out of twenty-nine respondents reported routinely monitoring tracheal cuff function, primarily employing cuff pressure measurement (26/28). Target cuff pressures varied, with 3/26 respondents aiming for 10 to 20 cmH2O, 10/26 for 21 to 25 cmH2O, and 13/26 for 26 to 30 cmH2O. Fifteen out of twenty-nine reported they had no current guideline or protocol for tracheal cuff management and only 16/29 indicated there was a dedicated area in the clinical record for reporting cuff intervention. The results indicated that many ICUs across Queensland routinely measure tracheal cuff function, with most utilising pressure monitoring devices. Consistent with existing literature, the optimum cuff pressure remains uncertain. Most, however, considered that this should be a routine part of ICU care". Thus, the available literature on ETCP and their relationship to clinical outcomes is lacking.

Being tested
monitoring of cuff pressures
Medical subject headings
Pneumonia, Ventilator-Associated

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • monitoring of cuff pressuresOther

    Cuff pressure will be checked per standard and additionally a minimum of every 8 hours.

Study groups in NCT02950519
Study groupRoleWhat they receive
As needed Cuff Pressure ChecksActive comparatorCuff pressure checks upon intubation and after any manipulation of ET tube
Receives: Other: monitoring of cuff pressures
Cuff Pressure checks every 8 hrsExperimentalCuff pressure checks upon intubation, after manipulation of ET tube, and minimum of 8 hr interval
Receives: Other: monitoring of cuff pressures

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ventilator Associated Condition (VAC) as defined by CDC

    Lung Condition that developed in association with mechanical ventilation

    Measured: 48 hours after intubation

Secondary outcomes (3)
  1. Length of stay (hospital)

    Through hospital admission until hospital discharge for patients admitted and discharged for a period up to 6 months

    Measured: Time in days of hospital stay for patients admitted and discharged for a period up to 6 months

  2. Hospital mortality

    Through hospital admission until hospital discharge up to a period of 6 months

    Measured: Any time during hospitalization up to a period of 6 months

  3. Ventilator Associated Pneumonia (VAP)

    Pneumonia that developed in association with mechanical ventilation

    Measured: 48 hrs after intubation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionNov 2017
  4. Study completionDec 2017

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
305 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02950519
Sponsor's protocol ID
201605155
Status last verified
Jan 2018
First submitted
6 Oct 2016
Last updated
18 Jan 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided: We are undecided on this point.

Questions about this trial

What is this clinical trial studying?

A study testing monitoring of cuff pressures in people with Pneumonia, Ventilator-Associated, run by Barnes-Jewish Hospital at 1 site in United States.

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 18 Jan 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 United States. 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?

Ventilator Associated Condition (VAC) as defined by CDC (time frame: 48 hours after intubation). 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 18 Jan 2018.

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