Optiflow THRIVE for Delivery of Oxygen to Patients During Total Intravenous Anesthesia While Undergoing Radiology Procedures

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

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-04

Study Completion Date

2024-06-21

Brief Summary

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This trial studies how well Optiflow THRIVE works in delivering oxygen to patients during total intravenous anesthesia while undergoing radiology procedures. The Optiflow THRIVE is an oxygen administration device that delivers high-flow and humidified oxygen through the nose. The Optiflow THRIVE device may improve oxygen delivery and reduce breathing complications.

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Detailed Description

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PRIMARY OBJECTIVE:

I. To investigate the performance of Optiflow THRIVE relative to Standard Non-Rebreathers in patients with high risk of difficult airway management undergoing interventional radiology procedures for the planning of future clinical studies.

SECONDARY OBJECTIVE:

I. To describe the episodes of hypoxia (defined by peripheral capillary oxygen saturation \[SpO2\] less than or equal to 92%) and the episodes of airway support which include: jaw thrust, chin lift or insertion of an airway supporting device, such as oral/nasal airway or supra airway device in order to recover the level of oxygenation above 92% associated with Optiflow THRIVE.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive 100% oxygen at a high flow rate via Optiflow THRIVE over 3 minutes prior to anesthetic induction and at a higher flow rate until the end of procedure.

ARM II: Patients receive 100% oxygen at a lower flow rate via non-rebreather mask over 3 minutes prior to anesthetic induction and maintain the same flow rate until the end of procedure.

After completion of study, patients are followed up at 15 minutes.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm I (oxygen via Optiflow THRIVE)

Patients receive 100% oxygen at a high flow rate via Optiflow THRIVE over 3 minutes prior to anesthetic induction and at a higher flow rate until the end of procedure.

Group Type EXPERIMENTAL

Oxygen Therapy

Intervention Type PROCEDURE

Receive oxygen via Optiflow THRIVE

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Optiflow THRIVE

Intervention Type DEVICE

Oxygen Administration

Arm II (oxygen via non-rebreather mask)

Patients receive 100% oxygen at a lower flow rate via non-rebreather mask over 3 minutes prior to anesthetic induction and maintain the same flow rate until the end of procedure.

Group Type ACTIVE_COMPARATOR

Oxygen Therapy

Intervention Type PROCEDURE

Receive oxygen via non-rebreather

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Oxygen Therapy

Receive oxygen via Optiflow THRIVE

Intervention Type PROCEDURE

Oxygen Therapy

Receive oxygen via non-rebreather

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Optiflow THRIVE

Oxygen Administration

Intervention Type DEVICE

Other Intervention Names

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supplemental oxygen therapy supplemental oxygen therapy

Eligibility Criteria

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Inclusion Criteria

* Signed consent for the study
* Patients with an SpO2 greater than or equal to 95% while breathing room air
* Patients requiring total intravenous anesthesia (TIVA) but not tracheal intubation during the proposed procedure - PLUS, any of the 2 following criteria: Body mass index (BMI) greater than or equal to 32 kg/m\^2, or neck circumference greater than or equal to 43 cm in a male and 41 cm in a female, or has been diagnosed with moderate to severe obstructive sleep apnea (OSA) with/without using a continuous positive airway pressure (CPAP) device
* Full course head and neck radiotherapy less than or equal to 6 months (the peak onset time of acute facial and airway edema)

Exclusion Criteria

* Significant pulmonary disease requiring supplemental oxygen in daily life (severe pulmonary fibrosis, severe chronic obstructive pulmonary disease, etc.)
* Significant cardiac disease (including history of myocardial infarction \[MI\] with concurrent evidence of ischemic myocardial damage at the event, cardiomyopathy with impaired left ventricular ejection fraction to less than 50% or uncompensated congestive heart failure)
* TIVA is contraindicate or having a proposed procedure without TIVA
* Endotracheal intubation is required
* American Society of Anesthesiologists (ASA) physical status classification 5
* Patients who are non-English speaking
* Emergency procedures

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No