Wounds and InjuriesP-VAPPNCT01902446
Prehospital Ventilator-Associated Pneumonia Prevention Trial
An observational study of Wounds and Injuries and Respiratory Failure, run by Nicholas M Mohr at 1 site in United States.
Trial summary
Traumatic injury in rural America is a significant cause of morbidity and mortality, and the challenges of a rural trauma system can put patients at unique risk. Prolonged transport times to a trauma center, stopping for care at referring hospitals, and longer exposure to care-associated factors distinguish rural… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds and Injuries, Respiratory Failure, Pneumonia, Ventilator-Associated
- What is being tested?
- Chlorhexidine gluconate
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Oct 2014
- Phase
- Observational
- 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
Study population: All intubated adult patients transported by air ambulance to the University of Iowa Hospitals and Clinics in interfacility transport after traumatic injury.
Who may be able to join
- Adults (age >= 18 years)
- Endotracheal intubation
- Transported by air ambulance
- Traumatic injury
- Interfacility transport (no flights from scene) en route to University of Iowa Hospitals and Clinics)
Who cannot join
- Known or suspected pregnancy
- Prisoners
- Patients diagnosed with pneumonia prior to transfer
- Known allergy to chlorhexidine gluconate
- Surgical airway (tracheostomy or cricothyroidotomy)
- Massive aspiration
- Anticipated nonsurvivable injury (survival projected < 24 hours)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
Official title: A Pilot Study of Prehospital Oral Chlorhexidine Gluconate to Prevent Early Ventilator Associated Pneumonia in Intubated Trauma Patients
Traumatic injury in rural America is a significant cause of morbidity and mortality, and the challenges of a rural trauma system can put patients at unique risk. Prolonged transport times to a trauma center, stopping for care at referring hospitals, and longer exposure to care-associated factors distinguish rural patients from their urban counterparts. Ventilator-associated pneumonia (VAP) is a significant risk in rural patients, increasing hospital stay, healthcare costs, and even mortality in the critically injured. The investigators propose a pilot study to test the hypothesis that a single dose of oral chlorhexidine gluconate (antiseptic) for trauma patients in the prehospital environment will decrease subsequent development of early VAP. Chlorhexidine is currently a standard therapy in intensive care units to prevent airway colonization and subsequent development of VAP. Demonstrating safety and effectiveness of prehospital infection control practices could significantly improve outcomes of traumatic injury in rural America.
- Being tested
- Chlorhexidine gluconate
- Keywords
- Chlorhexidine, Randomized Controlled Trial, Emergency Medical Services, Intubation, Endotracheal
- Medical subject headings
- Wounds and Injuries, Respiratory Insufficiency, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine gluconateDrug
Also called Peridex, PerioGard
Study solution will be applied to the oropharynx and will be distributed for 15 seconds with a swab stick. No suction will be applied for at least 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine gluconate | Intubated subjects transported by one air service will be treated with 5 mL chlorhexidine gluconate 0.12% applied for at least 30 seconds during helicopter transport. Receives: Drug: Chlorhexidine gluconate | |
| Normal saline (placebo) | Intubated subjects assigned transported by another air service will not have any additional treatment (in addition to usual care) during helicopter transport. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pulmonary Infection Score (CPIS)
Measured: 48-72 hours
Secondary outcomes (9)
Pneumonia - CPIS
This is the diagnosis of pneumonia within the first 5 days defined by CPIS score >=6.
Measured: 5 days
Pneumonia - CDC
This is the diagnosis of pneumonia using CDC criteria within 5 days of admission.
Measured: 5 days
Pneumonia - Treated
This is the diagnosis of pneumonia defined as antibiotic treatment of suspected pneumonia by the treating clinician.
Measured: 5 days
Pneumonia - Research
This is the diagnosis of pneumonia within 5 days as adjudicated by 3 clinicians blinded to treatment allocation.
Measured: 5 days
28-day ventilator-free days
Measured: 28 days
28-day ICU-free days
Measured: 28 days
Hospital Mortality
Measured: 28-days
Tracheostomy Rate
Measured: 28 days
Tracheal colonization
This analysis will be completed in two ways: the raw analysis will use a chi-squared test to test the null hypothesis that the distribution of semi-quantitative tracheal colonization is the same in the two groups. A second analysis will be performed using the ordinal shift method to compare the change (shift) in the semiquantitative score between admission and 48-72 hours.
Measured: 48-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicholas M Mohr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nicholas M Mohr, University of Iowa
- Investigators
- Nicholas M Mohr, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902446
- Sponsor's protocol ID
- 201304766
- Acronym
- P-VAPP
- Status last verified
- Jun 2017
- First submitted
- 15 Jul 2013
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Prehospital Oral Chlorhexidine Gluconate to Prevent Early Ventilator Associated Pneumonia in Intubated Trauma Patients
- ClinicalTrials.gov ID
- NCT01902446
- Acronym / sponsor ID
- P-VAPP / 201304766
- Keywords
- Chlorhexidine, Randomized Controlled Trial, Emergency Medical Services, Intubation, Endotracheal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Nicholas M MohrUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 18 Jul 2013 (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.
Traumatic injury in rural America is a significant cause of morbidity and mortality, and the challenges of a rural trauma system can put patients at unique risk. Prolonged transport times to a trauma center, stopping for care at referring hospitals, and longer exposure to care-associated factors distinguish rural patients from their urban counterparts. Ventilator-associated pneumonia (VAP) is a significant risk in rural patients, increasing hospital stay, healthcare costs, and even mortality in the critically injured. The investigators propose a pilot study to test the hypothesis that a single dose of oral chlorhexidine gluconate (antiseptic) for trauma patients in the prehospital environment will decrease subsequent development of early VAP. Chlorhexidine is currently a standard therapy in intensive care units to prevent airway colonization and subsequent development of VAP. Demonstrating safety and effectiveness of prehospital infection control practices could significantly improve outcomes of traumatic injury in rural America.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine gluconate | – | Drug: Chlorhexidine gluconateIntubated subjects transported by one air service will be treated with 5 mL chlorhexidine gluconate 0.12% applied for at least 30 seconds during helicopter transport. |
| Normal saline (placebo) | – | –Intubated subjects assigned transported by another air service will not have any additional treatment (in addition to usual care) during helicopter transport. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All intubated adult patients transported by air ambulance to the University of Iowa Hospitals and Clinics in interfacility transport after traumatic injury.
Key inclusion criteria (5 listed)
- Adults (age >= 18 years)
- Endotracheal intubation
- Transported by air ambulance
- Traumatic injury
- Interfacility transport (no flights from scene) en route to University of Iowa Hospitals and Clinics)
Key exclusion criteria (7 listed)
- Known or suspected pregnancy
- Prisoners
- Patients diagnosed with pneumonia prior to transfer
- Known allergy to chlorhexidine gluconate
- Surgical airway (tracheostomy or cricothyroidotomy)
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 |
|---|---|---|
| Chlorhexidine gluconateAlso: Peridex, PerioGardStudy solution will be applied to the oropharynx and will be distributed for 15 seconds with a swab stick. No suction will be applied for at least 30 seconds. | Drug | Chlorhexidine gluconate |
Primary outcome
Clinical Pulmonary Infection Score (CPIS)
Time frame: 48-72 hours
9 secondary outcomes
Pneumonia - CPIS
Time frame: 5 days
Pneumonia - CDC
Time frame: 5 days
Pneumonia - Treated
Time frame: 5 days
Pneumonia - Research
Time frame: 5 days
28-day ventilator-free days
Time frame: 28 days
28-day ICU-free days
Time frame: 28 days
Hospital Mortality
Time frame: 28-days
Tracheostomy Rate
Time frame: 28 days
Tracheal colonization
Time frame: 48-72 hours
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 9 Jun 2017.
Related trials for Wounds and Injuries
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
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.
Nicholas M Mohr, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds and Injuries and Respiratory Failure, run by Nicholas M Mohr 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 5 inclusion and 7 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 9 Jun 2017. 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?
Clinical Pulmonary Infection Score (CPIS) (time frame: 48-72 hours). 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 9 Jun 2017.