ICG Use in Angiography for Nasoseptal Flap Harvest

The Ohio State University

Status: Completed

Conditions: Skull Base Neoplasms

Treatments: Drug: indocyanine green

Study type: Interventional

Funder types: Other

Identifiers

NCT02117310

2013H0414

Details and patient eligibility

About

This is a feasibility study in which indocyanine green (ICG) will be administered during routine expanded endonasal approach (EEA) for cranial base pathologies in which a nasoseptal flap harvest will be necessary. The research entails administering ICG, which is already widely used during open neurosurgical procedures, to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case.

Full description

This study is being done to determine if it is feasible to use angiography during endo-nasal surgery. During the angiography indocyanine green (ICG) will be injected into the patients IV tubing to help see the arteries. ICG is routinely used in vascular surgeries on the brain but not for endo-nasal surgery. The purpose of this study is to see how well intraoperative angiography using ICG can be done during endonasal surgery.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 and above
• Patients undergoing an EEA for cranial base pathology that may require nasoseptal flap harvest

Exclusion criteria

• History of sulfa, iodide, or penicillin allergy
• Pregnant or breast feeding
• Preoperative lack of indication for nasoseptal flap harvest
• Previous anaphylactic reaction to ICG

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

ICG

Experimental group

Description:

Angiography with administered ICG

Treatment:

Drug: indocyanine green