RECRUITING
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Impact of Atelectasis on RVEDP Following Orthotropic Heart Transplantation
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.
Conditions:
🦠 Heart Transplant Failure 🦠 Anesthesia
🗓️ Study Start (Actual) 20 November 2023
🗓️ Primary Completion (Estimated) 1 November 2024
✅ Study Completion (Estimated) 1 November 2024
👥 Enrollment (Estimated) 15
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Houston, Texas, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Patients having undergone orthotropic heart transplantation
    • * Patients requiring routine heart catheterization for post-transplant surveillance
    • * General anesthesia

    Exclusion Criteria:

    • * 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
Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 15 November 2023
  • First Submitted that Met QC Criteria 15 November 2023
  • First Posted 20 November 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 20 December 2023
  • Last Update Posted 21 December 2023
  • Last Verified December 2023
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