NCT05234424

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

February 8, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2024

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

2.3 years

First QC Date

January 31, 2022

Last Update Submit

May 13, 2024

Conditions

Apneic Oxygenation

Keywords

THRIVEApneic oxygenationGeneral anesthesia

Outcome Measures

Primary Outcomes (1)

  • Arterial partial pressure of carbon dioxide (PaCO2) accumulation rate

    Linear mean accumulation rate of PaCO2 during THRIVE (kPa/min)

    10 minutes

Secondary Outcomes (8)

  • Arterial partial pressure of oxygen (PaO2)

    10 minutes

  • Peripheral saturation (SpO2)

    10 minutes

  • End-tidal carbon dioxide fraction (EtCO2)

    10 minutes

  • End-tidal oxygen fraction. (EtO2)

    10 minutes

  • End-expiratory lung impedance (EELI)

    10 minutes

  • +3 more secondary outcomes

Study Arms (2)

THRIVE 40 L/min

ACTIVE COMPARATOR

40 L/min with 100% oxygen for 10 minutes.

Other: THRIVE

THRIVE 100 L/min

EXPERIMENTAL

100 L/min with 100% oxygen for 10 minutes.

Other: THRIVE

Interventions

THRIVEOTHER

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.

THRIVE 100 L/minTHRIVE 40 L/min

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients presenting for elective surgery

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University Hospital

Uppsala, Uppsala County, 75185, Sweden

Location

MeSH Terms

Interventions

Nicotine

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Peter Frykholm, MD, PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participants are aware of the intervention used, but not aware of the order of flow rate tests.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant and Senior Lecturer, Section of Paediatric Anaesthesia and Intensive Care

Study Record Dates

First Submitted

January 31, 2022

First Posted

February 10, 2022

Study Start

February 8, 2022

Primary Completion

May 13, 2024

Study Completion

May 13, 2024

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)