Severe and Transient Hypoxemia During Selective Intra-arterial Chemotherapy for Retinoblastoma in Children: Evaluation of the Right-sided Heart Function.

June 5, 2018 updated by: Christian Kern
Children having selective ophthalmic artery chemotherapy for retinoblastoma under general anaesthesia may experience troubles during the procedure. The troubles are transient, may be severe and include hypoxemia, hypotension and bradycardia. All children having such trouble always fully recovered without any sequelae or prolonged length of stay. The investigators suspect that these phenomenons are caused by transient pulmonary hypertension.The objective is to see whether transient pulmonary hypertension and right-sided heart failure is present during theses phenomenon by trans-thoracic echocardiography.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • CHUV

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All children 0 to 6 years old having selective ophthalmic artery chemotherapy for retinoblastoma under general anaesthesia are eligible.

Description

Inclusion Criteria:

  • Retinoblastoma requiring selective ophthalmic artery chemotherapy under general anaesthesia

Exclusion Criteria:

  • Obesity
  • pre-existing significant heart or pulmonary disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identification of pulmonary hypertension and/or right-sided heart failure (systolic arterial pulmonary pressure and visual function of the right ventricle is measured)
Time Frame: Perioperative.
Perioperative.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christian Kern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Anticipated)

May 31, 2019

Study Completion (Anticipated)

May 31, 2019

Study Registration Dates

First Submitted

October 19, 2017

First Submitted That Met QC Criteria

June 5, 2018

First Posted (Actual)

June 18, 2018

Study Record Updates

Last Update Posted (Actual)

June 18, 2018

Last Update Submitted That Met QC Criteria

June 5, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-01539

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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