ICG Use in Angiography for Nasoseptal Flap Harvest

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Skull Base Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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ICG

Angiography with administered ICG

Group Type EXPERIMENTAL

indocyanine green

Intervention Type DRUG

ICG will be administered 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.

Interventions

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indocyanine green

ICG will be administered 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No