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

Obstructive Sleep Apnea Clinical Trial

Official title:

A Pilot Study of FDA Approved Optiflow™ THRIVE Versus Standard Non-Rebreathers in Patients With Potential High Risk of Airway Obstruction During Total Intravenous Anesthesia (TIVA) While Undergoing Interventional Radiology Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04171037
• Other study ID #: 2019-0348
• Secondary ID: NCI-2019-0729120
• Status: Recruiting
• Phase: N/A
• Start date: October 4, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: Gang Zheng
• Phone: 713-563-0117
• Email: gzheng[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Procedure:
• Oxygen Therapy
Receive oxygen via Optiflow THRIVE
• Oxygen Therapy
Receive oxygen via non-rebreather

Other:
• Questionnaire Administration
Ancillary studies

Device:
• Optiflow THRIVE
Oxygen Administration

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total length of desaturation episodes (ToLDE) time (in minutes)	Desaturation episodes are characterized by the occurrence of hypoxia (defined by peripheral capillary oxygen saturation [SpO2] less than or equal to 92%).	During a fixed 60-minute observation window during total intravenous anesthesia (TIVA)

External Links

•   M D Anderson Cancer Center website