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

Primary Purpose

Obstructive Sleep Apnea

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxygen Therapy
Oxygen Therapy
Questionnaire Administration
Optiflow THRIVE
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (oxygen via Optiflow THRIVE)

Arm II (oxygen via non-rebreather mask)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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%).

Secondary Outcome Measures

Full Information

First Posted
November 19, 2019
Last Updated
October 1, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04171037
Brief Title
Optiflow THRIVE for Delivery of Oxygen to Patients During Total Intravenous Anesthesia While Undergoing Radiology Procedures
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2019 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (oxygen via Optiflow THRIVE)
Arm Type
Experimental
Arm Description
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 Title
Arm II (oxygen via non-rebreather mask)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Oxygen Therapy
Other Intervention Name(s)
supplemental oxygen therapy
Intervention Description
Receive oxygen via Optiflow THRIVE
Intervention Type
Procedure
Intervention Name(s)
Oxygen Therapy
Other Intervention Name(s)
supplemental oxygen therapy
Intervention Description
Receive oxygen via non-rebreather
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Device
Intervention Name(s)
Optiflow THRIVE
Intervention Description
Oxygen Administration
Primary Outcome Measure Information:
Title
Total length of desaturation episodes (ToLDE) time (in minutes)
Description
Desaturation episodes are characterized by the occurrence of hypoxia (defined by peripheral capillary oxygen saturation [SpO2] less than or equal to 92%).
Time Frame
During a fixed 60-minute observation window during total intravenous anesthesia (TIVA)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gang Zheng
Phone
713-563-0117
Email
gzheng@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gang Zheng
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gang Zheng
Phone
713-563-0117
First Name & Middle Initial & Last Name & Degree
Gang Zheng

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center website

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

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