Impact of Atelectasis on RVEDP Following Orthotropic Heart Transplantation

Sponsor

Baylor College of Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06140810

Collaborator

(none)

Enrollment

11.1

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Transplant Failure Anesthesia	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 Design

Study Type:

Observational

Anticipated Enrollment :

15 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Nov 30, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Baylor College of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Adam Adler MD, MS, FAAP, Associate Professor of Anesthesiology, Baylor College of Medicine

ClinicalTrials.gov Identifier:

NCT06140810

Other Study ID Numbers:

H52547

First Posted:

Nov 20, 2023

Last Update Posted:

Nov 29, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pulmonary Atelectasis

Study Results

No Results Posted as of Nov 29, 2023