Pneumonia, Ventilator-AssociatedNCT02326207
Weekly Versus no Routine Ventilator Circuit Changes in NICU
A study testing Infant Ventilator Circuit Dual Heated with Autofeed Chamber in people with Pneumonia, Ventilator-Associated, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine incidence of ventilator-associated pneumonia compared between weekly and no routine ventilator circuit changes in neonatal intensive care unit Read more about this study
- Who is it for?
- Ages 1 day to 1 year
- Conditions the study is for
- Pneumonia, Ventilator-Associated
- What is being tested?
- Infant Ventilator Circuit Dual Heated with Autofeed Chamber
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2015to Mar 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 1 day to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All neonates who admitted at neonatal intensive care unit (NICU) and required ventilator support with both intubated at time of neonatal resuscitation and within the NICU as indicated
Who cannot join
- Patient was extubated or died within 2 calendar days of endotracheal intubation
- Pneumonia was diagnosed before intubation
- Outborn who was intubated before referred
- Parents declined to participate
- Incompatibility of disposable circuits and ventilator
- Chromosome abnormality or moribund
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Songklanagarind Hospital, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
About this study
Official title: Weekly Versus no Routine Ventilator Circuit Changes in Neonatal Intensive Care Unit: Prospective, Randomized Study
The purpose of this study is to determine incidence of ventilator-associated pneumonia compared between weekly and no routine ventilator circuit changes in neonatal intensive care unit
Read the detailed description
Parents were received informed consent. Enrolled neonates was randomly assigned to 2 groups as 7-day ventilator circuit change and no change group by computerization with allocated of concealment. The investigation team opened the next sequentially numbered study pack, which was stored in the neonatal unit. The assignment sequence was generated with balance within random block sizes of 4. Stratification according to birthweight was done before randomization to control for differences in patient populations. Patient characteristics were recorded as gestational age, sex, birthweight, underlying disease, date of intubation, date of extubation, duration of mechanical ventilator, reintubation, length of hospital stay, parenteral nutrition, medication (H2-blocker, PPI, narcotic drugs), transfusion and oral immune therapy. Laboratory data and radiographic data were recorded. Both groups received similarly care as the nurse was assigned to take care of patient in ratio 1-2 patients: 1 nurse, new disposable circuits were use in both groups and the VAP prevention protocol and the endotracheal suctioning protocol which followed by an American Academy of Respiratory Care (AARC) clinical practice guidelines were performed in both groups.
When the VAP was suspected the radiographic data were reviewed by two pediatric radiologists on the day of diagnosis, 3 days prior to the diagnosis and/or 2 and 7 days after diagnosis to confirm diagnosis of VAP if there is different in the results, the consensus must be made.
- Conditions
- Pneumonia, Ventilator-Associated
- Being tested
- Infant Ventilator Circuit Dual Heated with Autofeed Chamber
- Keywords
- Infant, Newborn, Neonatal intensive care unit, Ventilator circuit
- 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.
Infant Ventilator Circuit Dual Heated with Autofeed ChamberDevice
Also called Evaqua2, RT265
| Study group | Role | What they receive |
|---|---|---|
| Weekly ventilator circuit change | Experimental | Ventilator circuit change every 7 days until extubation Receives: Device: Infant Ventilator Circuit Dual Heated with Autofeed Chamber |
| No routine ventilator circuit change | Active comparator | No routine ventilator circuit change until soiling or malfunction or extubation Receives: Device: Infant Ventilator Circuit Dual Heated with Autofeed Chamber |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of ventilator-associated pneumonia (percentage of ventilator-associated pneumonia (events)/mechanically ventilated infant)
percentage of ventilator-associated pneumonia (events)/mechanically ventilated infant
Measured: within the first 30 days (plus or minus 7 days) after extubation
Secondary outcomes (2)
incidence of ventilator-associated pneumonia (ventilator-associated pneumonia (events)/1,000 ventilator days)
ventilator-associated pneumonia (events)/1,000 ventilator days
Measured: within the first 30 days (plus or minus 7 days) after extubation
Mortality rate
pneumonia-specific mortality within 7 days and at discharge
Measured: within the first 30 days (plus or minus 7 days) after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study startApr 2015
- Primary completionMar 2017
- Study completionMar 2017
Why it stopped: very low enrolled participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anucha Thatrimontrichai, Prince of Songkla University
- Investigators
- Anucha Thatrimontrichai, MD, Principal investigator, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326207
- Sponsor's protocol ID
- PSU 2014
- Status last verified
- Jun 2023
- First submitted
- 22 Dec 2014
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cernada M, Aguar M, Brugada M, Gutierrez A, Lopez JL, Castell M, Vento M. Ventilator-associated pneumonia in newborn infants diagnosed with an invasive bronchoalveolar lavage technique: a prospective observational study. Pediatr Crit Care Med. 2013 Jan;14(1):55-61. doi: 10.1097/PCC.0b013e318253ca31.
PubMed 22791095Apisarnthanarak A, Holzmann-Pazgal G, Hamvas A, Olsen MA, Fraser VJ. Ventilator-associated pneumonia in extremely preterm neonates in a neonatal intensive care unit: characteristics, risk factors, and outcomes. Pediatrics. 2003 Dec;112(6 Pt 1):1283-9. doi: 10.1542/peds.112.6.1283.
PubMed 14654598Afjeh SA, Sabzehei MK, Karimi A, Shiva F, Shamshiri AR. Surveillance of ventilator-associated pneumonia in a neonatal intensive care unit: characteristics, risk factors, and outcome. Arch Iran Med. 2012 Sep;15(9):567-71.
PubMed 22924377Kawanishi F, Yoshinaga M, Morita M, Shibata Y, Yamada T, Ooi Y, Ukimura A. Risk factors for ventilator-associated pneumonia in neonatal intensive care unit patients. J Infect Chemother. 2014 Oct;20(10):627-30. doi: 10.1016/j.jiac.2014.06.006. Epub 2014 Jul 4.
PubMed 25000829Han J, Liu Y. Effect of ventilator circuit changes on ventilator-associated pneumonia: a systematic review and meta-analysis. Respir Care. 2010 Apr;55(4):467-74.
PubMed 20406515Makhoul IR, Kassis I, Berant M, Hashman N, Revach M, Sujov P. Frequency of change of ventilator circuit in premature infants: Impact on ventilator-associated pneumonia. Pediatr Crit Care Med. 2001 Apr;2(2):127-132. doi: 10.1097/00130478-200104000-00006.
PubMed 12797871
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weekly Versus no Routine Ventilator Circuit Changes in Neonatal Intensive Care Unit: Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT02326207
- Acronym / sponsor ID
- PSU 2014
- Conditions
- Pneumonia, Ventilator-Associated
- Keywords
- Infant, Newborn, Neonatal intensive care unit, Ventilator circuit
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: very low enrolled participants
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 25 Dec 2014 (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.
The purpose of this study is to determine incidence of ventilator-associated pneumonia compared between weekly and no routine ventilator circuit changes in neonatal intensive care unit
Detailed description
Parents were received informed consent. Enrolled neonates was randomly assigned to 2 groups as 7-day ventilator circuit change and no change group by computerization with allocated of concealment. The investigation team opened the next sequentially numbered study pack, which was stored in the neonatal unit. The assignment sequence was generated with balance within random block sizes of 4. Stratification according to birthweight was done before randomization to control for differences in patient populations. Patient characteristics were recorded as gestational age, sex, birthweight, underlying disease, date of intubation, date of extubation, duration of mechanical ventilator, reintubation, length of hospital stay, parenteral nutrition, medication (H2-blocker, PPI, narcotic drugs), transfusion and oral immune therapy. Laboratory data and radiographic data were recorded. Both groups received similarly care as the nurse was assigned to take care of patient in ratio 1-2 patients: 1 nurse, new disposable circuits were use in both groups and the VAP prevention protocol and the endotracheal suctioning protocol which followed by an American Academy of Respiratory Care (AARC) clinical practice guidelines were performed in both groups.
When the VAP was suspected the radiographic data were reviewed by two pediatric radiologists on the day of diagnosis, 3 days prior to the diagnosis and/or 2 and 7 days after diagnosis to confirm diagnosis of VAP if there is different in the results, the consensus must be made.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weekly ventilator circuit change | Experimental | Device: Infant Ventilator Circuit Dual Heated with Autofeed ChamberVentilator circuit change every 7 days until extubation |
| No routine ventilator circuit change | Active comparator | Device: Infant Ventilator Circuit Dual Heated with Autofeed ChamberNo routine ventilator circuit change until soiling or malfunction or extubation |
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All neonates who admitted at neonatal intensive care unit (NICU) and required ventilator support with both intubated at time of neonatal resuscitation and within the NICU as indicated
Key exclusion criteria (6 listed)
- Patient was extubated or died within 2 calendar days of endotracheal intubation
- Pneumonia was diagnosed before intubation
- Outborn who was intubated before referred
- Parents declined to participate
- Incompatibility of disposable circuits and ventilator
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 |
|---|---|---|
| Infant Ventilator Circuit Dual Heated with Autofeed ChamberAlso: Evaqua2, RT265 | Device | No routine ventilator circuit change, Weekly ventilator circuit change |
Primary outcome
incidence of ventilator-associated pneumonia (percentage of ventilator-associated pneumonia (events)/mechanically ventilated infant)
Time frame: within the first 30 days (plus or minus 7 days) after extubation
percentage of ventilator-associated pneumonia (events)/mechanically ventilated infant
2 secondary outcomes
incidence of ventilator-associated pneumonia (ventilator-associated pneumonia (events)/1,000 ventilator days)
Time frame: within the first 30 days (plus or minus 7 days) after extubation
Mortality rate
Time frame: within the first 30 days (plus or minus 7 days) after discharge
Results and safety
The study was stopped early (reason given: very low enrolled participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Background: PubMed 22791095Cernada M, Aguar M, Brugada M, Gutierrez A, Lopez JL, Castell M, Vento M. Ventilator-associated pneumonia in newborn infants diagnosed with an invasive bronchoalveolar lavage technique: a prospective observational study. Pediatr Crit Care Med. 2013 Jan;14(1):55-61. doi: 10.1097/PCC.0b013e318253ca31.
- Background: PubMed 14654598Apisarnthanarak A, Holzmann-Pazgal G, Hamvas A, Olsen MA, Fraser VJ. Ventilator-associated pneumonia in extremely preterm neonates in a neonatal intensive care unit: characteristics, risk factors, and outcomes. Pediatrics. 2003 Dec;112(6 Pt 1):1283-9. doi: 10.1542/peds.112.6.1283.
- Background: PubMed 22924377Afjeh SA, Sabzehei MK, Karimi A, Shiva F, Shamshiri AR. Surveillance of ventilator-associated pneumonia in a neonatal intensive care unit: characteristics, risk factors, and outcome. Arch Iran Med. 2012 Sep;15(9):567-71.
- Background: PubMed 25000829Kawanishi F, Yoshinaga M, Morita M, Shibata Y, Yamada T, Ooi Y, Ukimura A. Risk factors for ventilator-associated pneumonia in neonatal intensive care unit patients. J Infect Chemother. 2014 Oct;20(10):627-30. doi: 10.1016/j.jiac.2014.06.006. Epub 2014 Jul 4.
- Background: PubMed 20406515Han J, Liu Y. Effect of ventilator circuit changes on ventilator-associated pneumonia: a systematic review and meta-analysis. Respir Care. 2010 Apr;55(4):467-74.
- Background: PubMed 12797871Makhoul IR, Kassis I, Berant M, Hashman N, Revach M, Sujov P. Frequency of change of ventilator circuit in premature infants: Impact on ventilator-associated pneumonia. Pediatr Crit Care Med. 2001 Apr;2(2):127-132. doi: 10.1097/00130478-200104000-00006.
Related trials for Pneumonia, Ventilator-Associated
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
Not yet recruitingPhase 3
Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP)
Recruiting
Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia
Ventilator-Associated Pneumonia (VAP)
Not yet recruiting
Mobile-Based Microlearning for Improving ICU Nurses' Adherence to Ventilator-Associated Pneumonia Prevention Protocols
Ventilator-Associated Pneumonia
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.
Anucha Thatrimontrichai, MD principal investigator
Prince of Songkla University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant Ventilator Circuit Dual Heated with Autofeed Chamber in people with Pneumonia, Ventilator-Associated, run by Prince of Songkla University at 1 site in Thailand.
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 6 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: stopped early, as of the sponsor's last update on 13 Jun 2023. 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 Thailand. 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 was stopped early (reason given: very low enrolled participants). Results are not available in the source record.
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?
incidence of ventilator-associated pneumonia (percentage of ventilator-associated pneumonia (events)/mechanically ventilated infant) (time frame: within the first 30 days (plus or minus 7 days) after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02326207, which also lists 6 linked publications.
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 13 Jun 2023.