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

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia; Heart Transplant Failure
• Intervention / Treatment: Other: Lung Recruitment

Detailed Description

Following orthoptopic heart transplantation (OHT), children undergo surveillance cardiac catheterizations to assess for signs of rejection including muscle biopsy as well as pressure measurements. These procedures are done under general anesthesia which promotes lung tissue collapse (atelectasis). Atalectaisis is known to alter intra-thoracic pressures and cardiac loading conditions. What is not known is the effect of atelectasis on intracardiac pressures which are a critical area of monitoring post-transplant patients for rejection. Therefore, the aim of this study is to identify if atelectasis impacts the pressure measurements obtained during cardiac catheterization.

• Study Type: Observational
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: adam adler, MD; Phone Number: 8328245800; Email: adam.adler@bcm.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Texas Childrens Hospital
      • Contact: Adam Adler, MD; Phone Number: 832-824-5800; Email: adam.adler@bcm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This is a study in patients following orthotropic heart transplantation meeting the inclusion exclusion 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Right ventricular End diastolic pressure; Measurement of pre and post recruitment right ventricular end diastolic pressure	Other: Lung Recruitment; Lung Recruitment will be performed during general anesthesia to reduce areas of atelectasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Investigators: Principal Investigator: adam adker, MD, Texas Childrens Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 20, 2023

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: H52547

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: De-identified data will be made available upon written request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No