Impact of Atelectasis on RVEDP Following Orthotropic Heart Transplantation

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06140810
• Other study ID #: H52547
• Status: Recruiting
• Start date: November 20, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: December 2023
• Source: Baylor College of Medicine
• Contact: Adam Adler, MD
• Phone: 8328245800
• Email: adam.adler[@]bcm.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Heart Transplant Failure
• Pulmonary Atelectasis

Intervention

Other:
• Lung Recruitment
Lung Recruitment will be performed during general anesthesia to reduce areas of atelectasis

Locations

Country	Name	City	State
United States	Texas Childrens Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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