A Study of the Efficacy of HFNC in Maintaining Oxygenation in Persons Undergoing Dental Treatment under Intravenous Sedation

JRCT ID: jRCTs072240107

Registered date:06/02/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: dental caries
• Date of first enrollment: 06/02/2025
• Target sample size: 144
• Study type: Interventional

Intervention(s)

Eligible patients who meet enrollment requirements will be randomly assigned to one of two groups after consent is obtained: the HFNC group and the LFNC group. Both groups will use the same standard nasal cannula and the AIRVO3TM as the device for mixing humidified air and oxygen. HFNC group: Study subjects will be placed in the supine position on the dental treatment unit, and a special cannula of the AIRVO3TM , the HFNC device, will be inserted through both nasal passages, and heated and humidified air/oxygen mixture (FiO2 0.28) is inhaled at a flow rate of 40 L/min. If SpO2 values show less than 90% during sedation, mandibular and mastoid elevation or forward movement of the mandible should be performed, and if this does not improve the patient should be managed by increasing the inhaled oxygen concentration. If any of the above airway clearance interventions are performed, they should be documented.
LFNC group: The study subjects will be placed in a supine position on the dental treatment unit and a special cannula of the AIRVO3TM , an HFNC device, will be inserted through both nasal cavities to inhale a heated and humidified air/oxygen mixture (FiO2 0.28) at a flow rate of 2 L/min.
If SpO2 values show less than 90% during sedation, mandibular and ottoman elevation or forward movement of the mandible should be performed, and if this does not improve, the patient should be managed with an increase in inhaled oxygen concentration. If any of the above airway clearance interventions are performed, record them.

Outcome(s)

• Primary Outcome: Incidence of Hypoxemia (SpO2 < 90%)

Secondary Outcome

1)Mean respiratory rate during sedation (an indirect measure of carbon dioxide accumulation)
2)Doses of sedative drugs (midazolam and propofol) per unit hour of anesthesia
3)Ramsay scale, an objective sedation assessment
4)Incidence of severe hypoxemia (SpO2 < 80%)
5)Number of oxygen flow changes for respiratory support devices (NHF, LFO)
6)Average flow used by NHF, and average FiO2 used (continuously recorded with AIRVO3)
7)Percentage of occurrences of sustained hypoxemia (definition: an event of hypoxemia (SpO2 < 90%) lasting more than 10 seconds)
8) Airway clearance interventions (mandibular and ottogai elevation, with or without and frequency of forward mandibular movement)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients scheduled to undergo dental treatment (generally within 2 hours) at the implementing medical institution
2) Patients undergoing dental treatment under sedation using a combination of midazolam and propofol
3) Men and women who are between 18 and 85 years of age at the time of consent.
4) Patients who have received a thorough explanation of their participation in this study, and who have given written consent of their own free will based on sufficient understanding.

Exclude criteria

1) Patients receiving continuous oxygen administration via nasal cannula (home oxygen therapy)
2) Patients with a history of pneumothorax
3) Patients with a history of bronchial asthma attack or severe asthma
4) Patients participating in clinical trials or other clinical studies
5) Patients who are judged to be inappropriate as research subjects by the principal investigator and subinvestigators.

Related Information

• Primary Sponsor: Ayuse Takao
• Source(s) of Monetary Support: Fisher &amp; Paykel (Fisher &amp; Paykel Healthcare Limited)