NCT03559894

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

June 18, 2018

Status Verified

June 1, 2018

Enrollment Period

1.4 years

First QC Date

October 19, 2017

Last Update Submit

June 5, 2018

Conditions

Retinoblastoma

Outcome Measures

Primary Outcomes (1)

  • Identification of pulmonary hypertension and/or right-sided heart failure (systolic arterial pulmonary pressure and visual function of the right ventricle is measured)

    Perioperative.

Interventions

Trans-thoracic echocardiographyDIAGNOSTIC_TEST

Trans-thoracic echocardiography

Eligibility Criteria

AgeUp to 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Retinoblastoma requiring selective ophthalmic artery chemotherapy under general anaesthesia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (5)

  • Phillips TJ, McGuirk SP, Chahal HK, Kingston J, Robertson F, Brew S, Roebuck D, Hungerford JL, Herod J. Autonomic cardio-respiratory reflex reactions and superselective ophthalmic arterial chemotherapy for retinoblastoma. Paediatr Anaesth. 2013 Oct;23(10):940-5. doi: 10.1111/pan.12162. Epub 2013 May 13.

    PMID: 23668238RESULT

  • Kato MA, Green N, O'Connell K, Till SD, Kramer DJ, Al-Khelaifi M, Han JH, Pryor KO, Gobin YP, Proekt A. A retrospective analysis of severe intraoperative respiratory compliance changes during ophthalmic arterial chemosurgery for retinoblastoma. Paediatr Anaesth. 2015 Jun;25(6):595-602. doi: 10.1111/pan.12603. Epub 2015 Jan 7.

    PMID: 25565164RESULT

  • Scharoun JH, Han JH, Gobin YP. Anesthesia for Ophthalmic Artery Chemosurgery. Anesthesiology. 2017 Jan;126(1):165-172. doi: 10.1097/ALN.0000000000001381. No abstract available.

    PMID: 27748655RESULT

  • Monroy JE, Orbach DB, VanderVeen D. Complications of intra-arterial chemotherapy for retinoblastoma. Semin Ophthalmol. 2014 Sep-Nov;29(5-6):429-33. doi: 10.3109/08820538.2014.959188.

    PMID: 25325870RESULT

  • Schaller B, Cornelius JF, Prabhakar H, Koerbel A, Gnanalingham K, Sandu N, Ottaviani G, Filis A, Buchfelder M; Trigemino-Cardiac Reflex Examination Group (TCREG). The trigemino-cardiac reflex: an update of the current knowledge. J Neurosurg Anesthesiol. 2009 Jul;21(3):187-95. doi: 10.1097/ANA.0b013e3181a2bf22.

    PMID: 19542994RESULT

MeSH Terms

Conditions

Retinoblastoma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueRetinal NeoplasmsEye NeoplasmsNeoplasms by SiteEye Diseases, HereditaryEye DiseasesRetinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 19, 2017

First Posted

June 18, 2018

Study Start

January 1, 2018

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

June 18, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)