Impact of Atelectasis on RVEDP Following Orthotropic Hear... | NCT06140810

Studies
Impact of Atelectasis on RVEDP Following Orthotropic Heart Transplantation

NCT06140810

Sponsor

Baylor College of Medicine

Status

Unknown status

Last Update Posted

Dec 21, 2023Actual

Enrollment

15Estimated

Phase

Not provided

Conditions

Heart Transplant Failure
Anesthesia

Interventions

Lung Recruitment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 20, 2023Actual

Primary Completion Date

Nov 1, 2024Estimated

Completion Date

Nov 1, 2024Estimated

First Submitted Date

Nov 15, 2023

First Submission Date that Met QC Criteria

Nov 15, 2023

First Posted Date

Nov 20, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 20, 2023

Last Update Posted Date

Dec 21, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

Baylor College of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Right ventricular End diastolic pressure		Measurement of pre and post recruitment right ventricular end diastolic pressure	Other: Lung Recruitment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lung Recruitment	Other	Lung Recruitment will be performed during general anesthesia to reduce areas of atelectasis	Right ventricular End diastolic pressure

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Adam Adler, MD	Contact	8328245800		adam.adler@bcm.edu

Overall Officials

Name	Affiliation	Role
adam adker, MD	Texas Childrens Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Texas Childrens Hospital	Recruiting	Houston	Texas	77030	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

De-identified data will be made available upon written request

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided