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.
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.
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.
- Conditions
- Pneumonia, Ventilator-Associated
- 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 group | Role | What they receive |
|---|---|---|
| As needed Cuff Pressure Checks | Active comparator | Cuff pressure checks upon intubation and after any manipulation of ET tube Receives: Other: monitoring of cuff pressures |
| Cuff Pressure checks every 8 hrs | Experimental | Cuff 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.
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)
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
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
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.
- First posted1 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionNov 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, Ventilator-AssociatedStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barnes-Jewish Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peggy Watts, Barnes-Jewish Hospital
- Investigators
- Marin Kollef, MD, Principal investigator, Washington University School of Medicine
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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Endotracheal Tube Cuff Pressures in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT02950519
- Acronym / sponsor ID
- 201605155
- Conditions
- Pneumonia, Ventilator-Associated
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Barnes-Jewish HospitalUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Nov 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 1 Nov 2016 (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.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| As needed Cuff Pressure Checks | Active comparator | Other: monitoring of cuff pressuresCuff pressure checks upon intubation and after any manipulation of ET tube |
| Cuff Pressure checks every 8 hrs | Experimental | Other: monitoring of cuff pressuresCuff pressure checks upon intubation, after manipulation of ET tube, and minimum of 8 hr interval |
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, 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 |
|---|---|---|
| monitoring of cuff pressuresCuff pressure will be checked per standard and additionally a minimum of every 8 hours. | Other | As needed Cuff Pressure Checks, Cuff Pressure checks every 8 hrs |
Primary outcome
Ventilator Associated Condition (VAC) as defined by CDC
Time frame: 48 hours after intubation
Lung Condition that developed in association with mechanical ventilation
3 secondary outcomes
Length of stay (hospital)
Time frame: Time in days of hospital stay for patients admitted and discharged for a period up to 6 months
Hospital mortality
Time frame: Any time during hospitalization up to a period of 6 months
Ventilator Associated Pneumonia (VAP)
Time frame: 48 hrs after intubation
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 18 Jan 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.
Marin Kollef, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
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.