Impact of Atelectasis on RVEDP Following Orthotropic Heart Transplantation

Recruiting

• Conditions: Heart Transplant Failure; Anesthesia
• Interventions: Other: Lung Recruitment

• Registration Number: NCT06140810
• Lead Sponsor: Baylor College of Medicine

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 Timeline

• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-15
• Study Start: 2023-11-20
• Study First Posted: 2023-11-20
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-20
• Last Update Posted: 2023-12-21
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Right ventricular End diastolic pressure	Lung Recruitment	Measurement of pre and post recruitment right ventricular end diastolic pressure

Primary Outcome Measures

Name	Time	Method
Number of participants with reduction of right ventricular end diastolic pressure of 3mmHg or greater	10 minutes	Change of the right ventricular end diastolic pressure from pre and post recruitment breaths

Trial Locations

Locations (1)

Texas Childrens Hospital; 🇺🇸 Houston, Texas, United States