Flow Rate Impact on Arterial Carbon Dioxide During THRIVE (ThriVent)
Primary Purpose
Apneic Oxygenation
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
THRIVE
Sponsored by
About this trial
This is an interventional treatment trial for Apneic Oxygenation focused on measuring THRIVE, Apneic oxygenation, General anesthesia
Eligibility Criteria
Inclusion Criteria:
- Patients presenting for elective surgery
Exclusion Criteria:
- Age <18 or >65 years
- Body Mass Index (BMI) >35 kg m-2
- American Society of Anesthesiology classification > 2
- Physical activity level less than 5 metabolic equivalents
- Obstruction of the upper airways
- Known or high clinical suspicion of difficult airway
- Obstructive sleep apnea syndrome
- Increased risk of aspiration
- Pulmonary or cardiac condition resulting in a reduction of physical activity level equivalent to the New York Heart Association class of 2 or higher.
- Any contraindication to high-flow nasal oxygen therapy or hypercapnia
- Pregnancy or breastfeeding
- Allergy to any of the anesthetic agents used in the study
- Inability to comprehend oral or written information.
Sites / Locations
- Uppsala University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
THRIVE 40 L/min
THRIVE 100 L/min
Arm Description
40 L/min with 100% oxygen for 10 minutes.
100 L/min with 100% oxygen for 10 minutes.
Outcomes
Primary Outcome Measures
Arterial partial pressure of carbon dioxide (PaCO2) accumulation rate
Linear mean accumulation rate of PaCO2 during THRIVE (kPa/min)
Secondary Outcome Measures
Arterial partial pressure of oxygen (PaO2)
Change of PaO2
Peripheral saturation (SpO2)
Change of SpO2 and lowest SpO2
End-tidal carbon dioxide fraction (EtCO2)
Change of EtCO2
End-tidal oxygen fraction. (EtO2)
Change of EtO2
End-expiratory lung impedance (EELI)
Change of EELI measured with electric impedance tomography
Respiratory compliance
Change of dynamic and static respiratory compliance
Heart rate
Change of heart rate
Blood pressure
Change of systolic, diastolic and mean arterial blood pressure.
Full Information
NCT ID
NCT05234424
First Posted
January 31, 2022
Last Updated
April 11, 2023
Sponsor
Uppsala University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05234424
Brief Title
Flow Rate Impact on Arterial Carbon Dioxide During THRIVE
Acronym
ThriVent
Official Title
Flow Rate Impact on Arterial Carbon Dioxide Accumulation During Transnasal Humidified Rapid-insufflation Ventilation Exchange: a Randomized Cross-over Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Apneic oxygenation describes the process of continuous oxygenation of the blood without breathing efforts. This anesthesia technique has been described in the literature for more than 100 years and is sometimes used under general anesthesia, e.g. during surgery of the vocal chords. Although this technique usually provides marked prolongation of the apneic period because of excellent oxygenation, it is limited by the absence of ventilation and the corresponding accumulation of carbon dioxide in the blood. This will lead to worsening respiratory acidosis and associated complications, such as cardiac arrythmias.
In 2015 it was reported that apneic oxygenation with high-flow nasal oxygen delivery systems (HFNO), a device that provides heated humidified oxygen at high flow rates (usually 30-70 L/min), resulted in less carbon dioxide accumulation compared with historical controls. This specific technique of apneic oxygenation was termed transnasal humidified rapid-insufflation ventilation exchange (THRIVE). To date, the impact on different flow rates on blood carbon dioxide accumulation during THRIVE is unknown. Specifically, very high flow rates, exceeding 70 L/min have not been investigated. Therefore, the aim of this trial is therefore to study the rate of accumulation of carbon dioxide during THRIVE at two different flow rates: 40 and 100 L/min.
Detailed Description
Eligible participants with signed informed consent presenting for elective surgery will have standard monitoring with ECG, pulse oximetry, blood pressure, train-of-four monitoring and capnography applied at arrival to the operating room. In addition, a circumferential electric impedance tomography thoracic elastic band with equally spaced electrodes will be placed in the 4th to 6th intercostal space. After induction of general anesthesia with a target controlled infusion of Propofol+Remifentanil and muscle relaxation with Rocuronium bromide, adequate face mask ventilation will be confirmed and arterial cannulation will be performed.
Patients will thereafter receive THRIVE at two flow rates for 10 minutes each in a randomized order. During THRIVE, video laryngoscopy will be performed with a grade 2B visualization of the larynx to establish similar airway patency during the interventions.
Before each flow, an end-tidal oxygen value of >0.85 and end-tidal carbon dioxide value of 4.5-5.0 kPa is achieved by controlled pressure regulated volume control ventilation to establish similar arterial partial pressure of oxygen and carbon dioxide at baseline. An arterial blood gas will also be analyzed before the start of each flow rate to ensure that the initial pCO2 is less than 6.0 kPa. Furthermore, a standardized lung recruitment maneuver will be performed to establish similar baseline compliance of the respiratory system.
Termination criteria will be:
All flow rates have been applied.
Severe acidemia (pH<7.10), hypercapnia (pCO2>11.0) or desaturation to SpO2 less than 90% for more than 10 seconds. These termination criteria will apply only to the current flow rate being tested. The participant will be mask ventilated until baseline parameters are established and the next THRIVE flow rate according to randomization will be applied.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apneic Oxygenation
Keywords
THRIVE, Apneic oxygenation, General anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
After induction of general anesthesia, confirmation of adequate face mask ventilation, and successful arterial cannulation, participants will be assigned to THRIVE flow rates in a randomized order.
Masking
Participant
Masking Description
The participants are aware of the intervention used, but not aware of the order of flow rate tests.
Allocation
Randomized
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
THRIVE 40 L/min
Arm Type
Active Comparator
Arm Description
40 L/min with 100% oxygen for 10 minutes.
Arm Title
THRIVE 100 L/min
Arm Type
Experimental
Arm Description
100 L/min with 100% oxygen for 10 minutes.
Intervention Type
Other
Intervention Name(s)
THRIVE
Intervention Description
During general anesthesia, apneic oxygenation with a high flow nasal oxygen system is applied for 10 minutes. Video laryngoscopy will be performed to achieve similar airway patency.
Primary Outcome Measure Information:
Title
Arterial partial pressure of carbon dioxide (PaCO2) accumulation rate
Description
Linear mean accumulation rate of PaCO2 during THRIVE (kPa/min)
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Arterial partial pressure of oxygen (PaO2)
Description
Change of PaO2
Time Frame
10 minutes
Title
Peripheral saturation (SpO2)
Description
Change of SpO2 and lowest SpO2
Time Frame
10 minutes
Title
End-tidal carbon dioxide fraction (EtCO2)
Description
Change of EtCO2
Time Frame
10 minutes
Title
End-tidal oxygen fraction. (EtO2)
Description
Change of EtO2
Time Frame
10 minutes
Title
End-expiratory lung impedance (EELI)
Description
Change of EELI measured with electric impedance tomography
Time Frame
10 minutes
Title
Respiratory compliance
Description
Change of dynamic and static respiratory compliance
Time Frame
10 minutes
Title
Heart rate
Description
Change of heart rate
Time Frame
10 minutes
Title
Blood pressure
Description
Change of systolic, diastolic and mean arterial blood pressure.
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients presenting for elective surgery
Exclusion Criteria:
Age <18 or >65 years
Body Mass Index (BMI) >35 kg m-2
American Society of Anesthesiology classification > 2
Physical activity level less than 5 metabolic equivalents
Obstruction of the upper airways
Known or high clinical suspicion of difficult airway
Obstructive sleep apnea syndrome
Increased risk of aspiration
Pulmonary or cardiac condition resulting in a reduction of physical activity level equivalent to the New York Heart Association class of 2 or higher.
Any contraindication to high-flow nasal oxygen therapy or hypercapnia
Pregnancy or breastfeeding
Allergy to any of the anesthetic agents used in the study
Inability to comprehend oral or written information.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Frykholm, MD, PhD
Phone
+46186110000
Email
peter.frykholm@surgsci.uu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Jacob Rosén, MD
Phone
+46186110000
Email
jacob.rosen@surgsci.uu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Frykholm, MD, PhD
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala University Hospital
City
Uppsala
State/Province
Uppsala County
ZIP/Postal Code
75185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Frykholm, PhD, MD
Phone
+46186110000
Email
peter.frykholm@surgsci.uu.se
First Name & Middle Initial & Last Name & Degree
Jacob Rosén, MD
Phone
+46186110000
Email
jacob.rosen@surgsci.uu.se
12. IPD Sharing Statement
Plan to Share IPD
No
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Flow Rate Impact on Arterial Carbon Dioxide During THRIVE
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