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Clinical Trials/NCT06140810
NCT06140810RecruitingNot Applicable

Impact of Atelectasis and Lung Recruitment on RVEDP Measurement in Children Undergoing Cardiac Catheterization for Surveillance Following Orthotropic Heart Transplantation

Baylor College of Medicine1 site in 1 country15 target enrollmentStarted: November 20, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
15
Locations
1
Primary Endpoint
Number of participants with reduction of right ventricular end diastolic pressure of 3mmHg or greater

Study Overview

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.

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Number of participants with reduction of right ventricular end diastolic pressure of 3mmHg or greater

Time Frame: 10 minutes

Change of the right ventricular end diastolic pressure from pre and post recruitment breaths

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Adam Adler MD, MS, FAAP

Associate Professor of Anesthesiology

Baylor College of Medicine

Study Sites (1)

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