Impact of Atelectasis on RVEDP Following Orthotropic Heart Transplantation
Impact of Atelectasis and Lung Recruitment on RVEDP Measurement in Children Undergoing Cardiac Catheterization for Surveillance Following Orthotropic Heart Transplantation
1 other identifier
observational
15
1 country
1
Brief Summary
Following orthoptopic heart transplantation (OHT), children undergo surveillance cardiac catheterizations to assess for signs of rejection including muscle biopsy as well as pressure measurements to guide post transplant treatment regiments. These procedures are done under general anesthesia which promotes lung tissue collapse (atelectasis). What is not known is the effect of atelectasis on intracardiac pressures which are a critical area of monitoring post-transplant patients for rejection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2023
CompletedFirst Posted
Study publicly available on registry
November 20, 2023
CompletedStudy Start
First participant enrolled
November 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedDecember 21, 2023
December 1, 2023
12 months
November 15, 2023
December 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with reduction of right ventricular end diastolic pressure of 3mmHg or greater
Change of the right ventricular end diastolic pressure from pre and post recruitment breaths
10 minutes
Study Arms (1)
Right ventricular End diastolic pressure
Measurement of pre and post recruitment right ventricular end diastolic pressure
Interventions
Lung Recruitment will be performed during general anesthesia to reduce areas of atelectasis
Eligibility Criteria
This is a study in patients following orthotropic heart transplantation meeting the inclusion exclusion criteria.
You may qualify if:
- Patients having undergone orthotropic heart transplantation
- Patients requiring routine heart catheterization for post-transplant surveillance
- General anesthesia
You may not qualify if:
- Patient/parental refusal
- Patients with suspected or known acute rejection
- Known anti-rejection medication non-compliance
- Patients within 1 year following heart transplant
- Home oxygen requirement
- Previous lung surgery (e.g., lobectomy) other than biopsy
- Lung transplantation
- Known pulmonary fibrosis
- Known pulmonary hypertension (\>1/2 systemic)
- Sedation without the use of an airway device
- Active respiratory infection -Inability to provide recruitment breaths \>25mmHg -Cardiomegaly
- Recipient/donor size mismatch
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Texas Childrens Hospital
Houston, Texas, 77030, United States
Study Officials
- PRINCIPAL INVESTIGATOR
adam adker, MD
Texas Childrens Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Anesthesiology
Study Record Dates
First Submitted
November 15, 2023
First Posted
November 20, 2023
Study Start
November 20, 2023
Primary Completion
November 1, 2024
Study Completion
November 1, 2024
Last Updated
December 21, 2023
Record last verified: 2023-12