Tricuspid RegurgitationNCT06229886
Effect of PEEP on TRJV in Mechanically Intubated Pediatric Patients
A study testing Application of positive-end-expiratory pressure in people with Tricuspid Regurgitation and Mechanical Ventilation Pressure High, run by Northwell Health at 1 site in United States.
Trial summary
Prospective observational cohort study within the Pediatric Intensive Care Unit (PICU). We will perform point-of-care-ultrasound (POCUS) to quantify tricuspid regurgitant jet velocity (TRJV) on mechanically ventilated (MV) children. Read more about this study
- Who is it for?
- Ages 3 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Tricuspid Regurgitation, Mechanical Ventilation Pressure High, Pediatric Respiratory Diseases
- What is being tested?
- Application of positive-end-expiratory pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2023to 21 Sep 2024
- 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 3 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients admitted to Cohen Children's Medical Center (CCMC) PICU who are age 3 months - 18 years old who are invasively mechanically ventilated (oral or nasotracheally).
- Patients on or approaching extubation readiness trial.
- Patients with structurally normal heart.
- Patients with normally functioning heart.
- Consent by a legal guardian.
Who cannot join
- Patients with known air-leak syndrome.
- Patients with history of congenital heart disease (CHD) (pre/post repair).
- Patients with significant cardiac dysfunction and/or on vasoactive medications.
- Patients with history of cardiomyopathy.
- Patients with history of pulmonary hypertension.
- Patients with history of chronic respiratory failure.
- Patients with known mediastinal mass.
- Patients with tracheostomy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cohen Children's Medical Center
New Hyde Park, New York, 11040
About this study
Official title: Effect of Positive End-Expiratory Pressure on Tricuspid Regurgitant Jet Velocity in Pediatric Patients on Invasive Mechanical Ventilation
Prospective observational cohort study within the Pediatric Intensive Care Unit (PICU). We will perform point-of-care-ultrasound (POCUS) to quantify tricuspid regurgitant jet velocity (TRJV) on mechanically ventilated (MV) children. Mechanically ventilated (MV) children approaching extubation as per the discretion of the PICU clinical team will undergo a positive end expiratory pressure (PEEP) titration protocol in a safe and timely manner in the PICU. During this PEEP titration, POCUS will be performed by a pediatric intensivist and interpreted by a pediatric cardiologist. Medical demographics will be collected from the electronic medical record and recorded.
Read the detailed description
New admissions to the PICU will be identified by screening the electronic medical record (EMR) and all intubated patients will be screened and approached for enrollment if they meet inclusion criteria. After informed consent is obtained, subjects will be assigned a unique identifying number. Data will be stored in REDCap. A master link connecting subject POCUS image will be locked in the PI's office.
- POCUS measurements: POCUS will be performed when a patient is determined to meet extubation readiness criteria as decided by the PICU clinical team. When the patient is on extubation readiness trial (ERT) settings (PEEP baseline), POCUS will be performed to assess TRJV. The PEEP will be increased to PEEP baseline+3 for 15 minutes followed by a repeat POCUS to assess TRJV. The PEEP will then be increased to PEEP baseline+5 (for a max total PEEP of 10mmHg) for 15 minutes followed by a repeat POCUS to assess TRJV. The patients will then be returned to baseline ERT (PEEP baseline) settings prior to the initial POCUS.
- Interrater reliability will be evaluated amongst trained ultrasound providers by means of performing double scans for 25% of all scans performed. Each subject included in the study will have 3 scans in total (scan at PEEP baseline, scan at PEEP baseline+3, scan at PEEP baseline+5). Since the total number of scans in this study is 90, the number of double scans performed for interrater reliability will be about 22. Each double scan will include an expert ultrasound provider, along with novice ultrasound providers, who will be collecting data for this study. The novice ultrasound provider will participate in a brief informational session of how to obtain and interpret images with the expert provider.
- Images will be stored in QPATH (our secure ultrasound-image database) and will not have any patient identifiers included. In addition, the attending of record will be contacted to determine if there are any extenuating medical or social circumstances that they believe should preclude the research team from performing the POCUS. If there are, the research team will forgo the POCUS.
- The POCUS will then be reviewed by a board certified cardiologist and measurements of the TRJV will be obtained. The cardiologist will be blinded to the patient.
- Information will be obtained from the EMR as outlined in our data collection sheet.
- Conditions
- Tricuspid Regurgitation, Mechanical Ventilation Pressure High, Pediatric Respiratory Diseases
- Being tested
- Application of positive-end-expiratory pressure
- Keywords
- PEEP, Invasive Mechanical Ventilation, Tricuspid Regurgitant Jet Velocity, Point-of-care-ultrasound
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of positive-end-expiratory pressureOther
Application of PEEP on mechanically ventilated pediatric patients. Point-of-care-ultrasound performed after each PEEP application.
| Study group | Role | What they receive |
|---|---|---|
| Study Participants | Experimental | Application of positive-end-expiratory-pressure on mechanically ventilated patients while performing point-of-care-ultrasound. Receives: Other: Application of positive-end-expiratory pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tricuspid Regurgitant Jet Velocity
The primary endpoint for the study will be TRJV at baseline PEEP (PEEP baseline) and subsequent PEEP increments (PEEP baseline+3, PEEP baseline+5).
Measured: 30 minutes
Secondary outcomes (4)
Systolic Blood Pressure
mmHg
Measured: 30 minutes
Diastolic Blood Pressure
mmHg
Measured: 30 minutes
Mean Arterial Pressure
mmHg
Measured: 30 Minutes
Heart Rate
BPM (beats per minute)
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start6 Dec 2023
- Primary completion1 Apr 2024
- Study completion21 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iris Mandell, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229886
- Sponsor's protocol ID
- 23-0615
- Status last verified
- Sep 2024
- First submitted
- 9 Jan 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Artucio H, Hurtado J, Zimet L, de Paula J, Beron M. PEEP-induced tricuspid regurgitation. Intensive Care Med. 1997 Aug;23(8):836-40. doi: 10.1007/s001340050419.
PubMed 9310800Binder ZW, O'Brien SE, Boyle TP, Cabral HJ, Sekhavat S, Pare JR. Novice Physician Ultrasound Evaluation of Pediatric Tricuspid Regurgitant Jet Velocity. West J Emerg Med. 2020 Jun 24;21(4):1029-1035. doi: 10.5811/westjem.2020.3.45882.
PubMed 32726279Binder ZW, O'Brien SE, Boyle TP, Cabral HJ, Pare JR. Tricuspid Regurgitant Jet Velocity Point-of-Care Ultrasound Curriculum Development and Validation. POCUS J. 2021 Nov 23;6(2):88-92. doi: 10.24908/pocus.v6i2.15190.
PubMed 35899222Brower RG, Lanken PN, MacIntyre N, Matthay MA, Morris A, Ancukiewicz M, Schoenfeld D, Thompson BT; National Heart, Lung, and Blood Institute ARDS Clinical Trials Network. Higher versus lower positive end-expiratory pressures in patients with the acute respiratory distress syndrome. N Engl J Med. 2004 Jul 22;351(4):327-36. doi: 10.1056/NEJMoa032193.
PubMed 15269312Jone PN, Ivy DD. Echocardiography in pediatric pulmonary hypertension. Front Pediatr. 2014 Nov 12;2:124. doi: 10.3389/fped.2014.00124. eCollection 2014.
PubMed 25429362Jullien T, Valtier B, Hongnat JM, Dubourg O, Bourdarias JP, Jardin F. Incidence of tricuspid regurgitation and vena caval backward flow in mechanically ventilated patients. A color Doppler and contrast echocardiographic study. Chest. 1995 Feb;107(2):488-93. doi: 10.1378/chest.107.2.488.
PubMed 7842782Khandelwal A, Kapoor I, Mahajan C, Prabhakar H. Effect of Positive End-Expiratory Pressure on Optic Nerve Sheath Diameter in Pediatric Patients with Traumatic Brain Injury. J Pediatr Neurosci. 2018 Apr-Jun;13(2):165-169. doi: 10.4103/jpn.JPN_112_17.
PubMed 30090129Lai C, Shi R, Beurton A, Moretto F, Ayed S, Fage N, Gavelli F, Pavot A, Dres M, Teboul JL, Monnet X. The increase in cardiac output induced by a decrease in positive end-expiratory pressure reliably detects volume responsiveness: the PEEP-test study. Crit Care. 2023 Apr 9;27(1):136. doi: 10.1186/s13054-023-04424-7.
PubMed 37031182Persson JN, Kim JS, Good RJ. Diagnostic Utility of Point-of-Care Ultrasound in the Pediatric Cardiac Intensive Care Unit. Curr Treat Options Pediatr. 2022;8(3):151-173. doi: 10.1007/s40746-022-00250-1. Epub 2022 Jul 8.
PubMed 36277259Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
PubMed 10793162Watkins LA, Dial SP, Koenig SJ, Kurepa DN, Mayo PH. The Utility of Point-of-Care Ultrasound in the Pediatric Intensive Care Unit. J Intensive Care Med. 2022 Aug;37(8):1029-1036. doi: 10.1177/08850666211047824. Epub 2021 Oct 9.
PubMed 34632837
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Positive End-Expiratory Pressure on Tricuspid Regurgitant Jet Velocity in Pediatric Patients on Invasive Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT06229886
- Acronym / sponsor ID
- 23-0615
- Conditions
- Tricuspid Regurgitation, Mechanical Ventilation Pressure High, Pediatric Respiratory Diseases
- Keywords
- PEEP, Invasive Mechanical Ventilation, Tricuspid Regurgitant Jet Velocity, Point-of-care-ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 21 Sep 2024 (actual)
- First posted
- 29 Jan 2024 (actual)
- 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.
Prospective observational cohort study within the Pediatric Intensive Care Unit (PICU). We will perform point-of-care-ultrasound (POCUS) to quantify tricuspid regurgitant jet velocity (TRJV) on mechanically ventilated (MV) children. Mechanically ventilated (MV) children approaching extubation as per the discretion of the PICU clinical team will undergo a positive end expiratory pressure (PEEP) titration protocol in a safe and timely manner in the PICU. During this PEEP titration, POCUS will be performed by a pediatric intensivist and interpreted by a pediatric cardiologist. Medical demographics will be collected from the electronic medical record and recorded.
Detailed description
New admissions to the PICU will be identified by screening the electronic medical record (EMR) and all intubated patients will be screened and approached for enrollment if they meet inclusion criteria. After informed consent is obtained, subjects will be assigned a unique identifying number. Data will be stored in REDCap. A master link connecting subject POCUS image will be locked in the PI's office.
- POCUS measurements: POCUS will be performed when a patient is determined to meet extubation readiness criteria as decided by the PICU clinical team. When the patient is on extubation readiness trial (ERT) settings (PEEP baseline), POCUS will be performed to assess TRJV. The PEEP will be increased to PEEP baseline+3 for 15 minutes followed by a repeat POCUS to assess TRJV. The PEEP will then be increased to PEEP baseline+5 (for a max total PEEP of 10mmHg) for 15 minutes followed by a repeat POCUS to assess TRJV. The patients will then be returned to baseline ERT (PEEP baseline) settings prior to the initial POCUS.
- Interrater reliability will be evaluated amongst trained ultrasound providers by means of performing double scans for 25% of all scans performed. Each subject included in the study will have 3 scans in total (scan at PEEP baseline, scan at PEEP baseline+3, scan at PEEP baseline+5). Since the total number of scans in this study is 90, the number of double scans performed for interrater reliability will be about 22. Each double scan will include an expert ultrasound provider, along with novice ultrasound providers, who will be collecting data for this study. The novice ultrasound provider will participate in a brief informational session of how to obtain and interpret images with the expert provider.
- Images will be stored in QPATH (our secure ultrasound-image database) and will not have any patient identifiers included. In addition, the attending of record will be contacted to determine if there are any extenuating medical or social circumstances that they believe should preclude the research team from performing the POCUS. If there are, the research team will forgo the POCUS.
- The POCUS will then be reviewed by a board certified cardiologist and measurements of the TRJV will be obtained. The cardiologist will be blinded to the patient.
- Information will be obtained from the EMR as outlined in our data collection sheet.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Participants | Experimental | Other: Application of positive-end-expiratory pressureApplication of positive-end-expiratory-pressure on mechanically ventilated patients while performing point-of-care-ultrasound. |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients admitted to Cohen Children's Medical Center (CCMC) PICU who are age 3 months - 18 years old who are invasively mechanically ventilated (oral or nasotracheally).
- Patients on or approaching extubation readiness trial.
- Patients with structurally normal heart.
- Patients with normally functioning heart.
- Consent by a legal guardian.
Key exclusion criteria (8 listed)
- Patients with known air-leak syndrome.
- Patients with history of congenital heart disease (CHD) (pre/post repair).
- Patients with significant cardiac dysfunction and/or on vasoactive medications.
- Patients with history of cardiomyopathy.
- Patients with history of pulmonary hypertension.
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 |
|---|---|---|
| Application of positive-end-expiratory pressureApplication of PEEP on mechanically ventilated pediatric patients. Point-of-care-ultrasound performed after each PEEP application. | Other | Study Participants |
Primary outcome
Tricuspid Regurgitant Jet Velocity
Time frame: 30 minutes
The primary endpoint for the study will be TRJV at baseline PEEP (PEEP baseline) and subsequent PEEP increments (PEEP baseline+3, PEEP baseline+5).
4 secondary outcomes
Systolic Blood Pressure
Time frame: 30 minutes
Diastolic Blood Pressure
Time frame: 30 minutes
Mean Arterial Pressure
Time frame: 30 Minutes
Heart Rate
Time frame: 30 minutes
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 26 Sep 2024.
- Background: PubMed 9310800Artucio H, Hurtado J, Zimet L, de Paula J, Beron M. PEEP-induced tricuspid regurgitation. Intensive Care Med. 1997 Aug;23(8):836-40. doi: 10.1007/s001340050419.
- Background: PubMed 32726279Binder ZW, O'Brien SE, Boyle TP, Cabral HJ, Sekhavat S, Pare JR. Novice Physician Ultrasound Evaluation of Pediatric Tricuspid Regurgitant Jet Velocity. West J Emerg Med. 2020 Jun 24;21(4):1029-1035. doi: 10.5811/westjem.2020.3.45882.
- Background: PubMed 35899222Binder ZW, O'Brien SE, Boyle TP, Cabral HJ, Pare JR. Tricuspid Regurgitant Jet Velocity Point-of-Care Ultrasound Curriculum Development and Validation. POCUS J. 2021 Nov 23;6(2):88-92. doi: 10.24908/pocus.v6i2.15190.
- Background: PubMed 15269312Brower RG, Lanken PN, MacIntyre N, Matthay MA, Morris A, Ancukiewicz M, Schoenfeld D, Thompson BT; National Heart, Lung, and Blood Institute ARDS Clinical Trials Network. Higher versus lower positive end-expiratory pressures in patients with the acute respiratory distress syndrome. N Engl J Med. 2004 Jul 22;351(4):327-36. doi: 10.1056/NEJMoa032193.
- Background: PubMed 25429362Jone PN, Ivy DD. Echocardiography in pediatric pulmonary hypertension. Front Pediatr. 2014 Nov 12;2:124. doi: 10.3389/fped.2014.00124. eCollection 2014.
- Background: PubMed 7842782Jullien T, Valtier B, Hongnat JM, Dubourg O, Bourdarias JP, Jardin F. Incidence of tricuspid regurgitation and vena caval backward flow in mechanically ventilated patients. A color Doppler and contrast echocardiographic study. Chest. 1995 Feb;107(2):488-93. doi: 10.1378/chest.107.2.488.
- Background: PubMed 30090129Khandelwal A, Kapoor I, Mahajan C, Prabhakar H. Effect of Positive End-Expiratory Pressure on Optic Nerve Sheath Diameter in Pediatric Patients with Traumatic Brain Injury. J Pediatr Neurosci. 2018 Apr-Jun;13(2):165-169. doi: 10.4103/jpn.JPN_112_17.
- Background: PubMed 37031182Lai C, Shi R, Beurton A, Moretto F, Ayed S, Fage N, Gavelli F, Pavot A, Dres M, Teboul JL, Monnet X. The increase in cardiac output induced by a decrease in positive end-expiratory pressure reliably detects volume responsiveness: the PEEP-test study. Crit Care. 2023 Apr 9;27(1):136. doi: 10.1186/s13054-023-04424-7.
- Background: PubMed 36277259Persson JN, Kim JS, Good RJ. Diagnostic Utility of Point-of-Care Ultrasound in the Pediatric Cardiac Intensive Care Unit. Curr Treat Options Pediatr. 2022;8(3):151-173. doi: 10.1007/s40746-022-00250-1. Epub 2022 Jul 8.
- Background: PubMed 10793162Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
- Background: PubMed 34632837Watkins LA, Dial SP, Koenig SJ, Kurepa DN, Mayo PH. The Utility of Point-of-Care Ultrasound in the Pediatric Intensive Care Unit. J Intensive Care Med. 2022 Aug;37(8):1029-1036. doi: 10.1177/08850666211047824. Epub 2021 Oct 9.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of positive-end-expiratory pressure in people with Tricuspid Regurgitation and Mechanical Ventilation Pressure High, run by Northwell Health 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 8 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 26 Sep 2024. 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?
Tricuspid Regurgitant Jet Velocity (time frame: 30 minutes). 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 NCT06229886, which also lists 11 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 26 Sep 2024.