Flow Rate Impact on Arterial Carbon Dioxide During THRIVE (ThriVent)

Flow Rate Impact on Arterial Carbon Dioxide Accumulation During Transnasal Humidified Rapid-insufflation Ventilation Exchange: a Randomized Cross-over Study

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.

Study Overview

• Status: Terminated
• Conditions: Apneic Oxygenation
• Intervention / Treatment: Other: THRIVE

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Uppsala County
    • Uppsala, Uppsala County, Sweden, 75185
      • Uppsala University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: THRIVE 40 L/min; 40 L/min with 100% oxygen for 10 minutes.	Other: THRIVE; 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.
Experimental: THRIVE 100 L/min; 100 L/min with 100% oxygen for 10 minutes.	Other: THRIVE; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial partial pressure of carbon dioxide (PaCO2) accumulation rate	Linear mean accumulation rate of PaCO2 during THRIVE (kPa/min)	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial partial pressure of oxygen (PaO2)	Change of PaO2	10 minutes
Peripheral saturation (SpO2)	Change of SpO2 and lowest SpO2	10 minutes
End-tidal carbon dioxide fraction (EtCO2)	Change of EtCO2	10 minutes
End-tidal oxygen fraction. (EtO2)	Change of EtO2	10 minutes
End-expiratory lung impedance (EELI)	Change of EELI measured with electric impedance tomography	10 minutes
Respiratory compliance	Change of dynamic and static respiratory compliance	10 minutes
Heart rate	Change of heart rate	10 minutes
Blood pressure	Change of systolic, diastolic and mean arterial blood pressure.	10 minutes

Collaborators and Investigators

• Sponsor: Uppsala University Hospital
• Investigators: Principal Investigator: Peter Frykholm, MD, PhD, Uppsala University

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2022
• Primary Completion (Actual): May 13, 2024
• Study Completion (Actual): May 13, 2024

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: THRIVE; General anesthesia; Apneic oxygenation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Apnea
• Other Study ID Numbers: Frykholm2201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No