Efficacy of HFNC Respiratory Management to Post-extubation Acute Pulmonary Recruitment in Oral Surgery Patients

JRCT ID: jRCTs072240111

Registered date:14/02/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Oral disease
• Date of first enrollment: 14/02/2025
• Target sample size: 40
• Study type: Interventional

Intervention(s)

After extubation, study subjects will be randomly assigned to receive HFNC respiratory management using AIRVO3(HFNC group) or oxygen therapy using a nasal cannula (nasal cannula group).

Postoperative respiratory management will be performed according to the assigned group as follows
HFNC group
HFNC respiratory management using AIRVO3 immediately after extubation(30 L/min: FiO2 0.32)

Nasal cannula group
Oxygen therapy with nasal cannula immediately after extubation(3L: FiO2 0.32)

In both groups, patients are placed supine on the operating table before the start of anesthesia, and an EIT sensor is placed on the patient's chest in addition to the usual patient monitoring monitors transcutaneous oxygen saturation, electrocardiogram, and non-invasive blood pressure monitor. Values immediately before induction of anesthesia, during anesthesia just before the start of surgery, at the end of surgery before awakening from anesthesia, and after extubation are taken at each point without being affected by other operations. After returning to the general ward, continuous measurements will be made up to 3 hours after returning to the ward continuously by the sensor of the EIT that is attached to the patient. In particular, the values immediately after return, at 1 hour, and at 3 hours after return will be taken without any influence of other operations. For respiratory control, the HFNC group will receive 30 L/min oxygen/air mixture (FiO2:0.32) through a special nasal cannula (Duet + optiflow) of Airvo3, which will be placed on the nose immediately after extubation, and the nasal cannula group will receive 3 L/min oxygen through a regular nasal cannula immediately after extubation.

Both groups will be monitored for lung recruitment effects by assessing regional lung ventilation distribution and alveolar air content until 3 hours after return to the general ward. Monitoring of lung recruitment effects will be assessed using EIT in four ventral to dorsal horizontal regions of interest divided equally. The ROX index (=SpO2/FiO2/ respiratory rate) will also be calculated later from the data(SpO2, respiratory rate, and oxygenation) collected continuously using Airvo3.
If transcutaneous oxygen saturation drops below 90% during the procedure, oxygenation (FiO2) is increased for safe respiratory management.

Outcome(s)

Primary Outcome

Evaluation by electrical chest tomography with EIT
1) Effect of PEEP augmentation: global delta EELZ, ventral delta EELZ, dorsal delta EELZ, GI index
2) Improvement of respiratory workload: Delta Z, total tidal volume (TV), ventral TV, dorsal TV, minute minute ventilation rate, corrected minute ventilation rate (= minute ventilation rate x PaCO2/40)

• Secondary Outcome: ROX index

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

(i) Patients undergoing oral surgery under general anesthesia with a scheduled application surgery time of 4-5 hours.
(ii) Patients undergoing respiratory management with oxygen administration during the acute postoperative period (3 to 5 hours) until they are released after returning to the general ward.
(iii) Patients whose age is between 18 and 85 years old at the time of obtaining consent.
(iv) 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

(i) Patients already receiving continuous oxygen administration via nasal cannula (home oxygen therapy)
(ii) Patients who cannot breathe through the nose
(iii) Patients who cannot reduce or discontinue antithrombotic drugs after surgery
(iv) Patients with a history of pneumothorax
(v) Patients with significant postoperative morphological changes such as extensive resection of the jawbone
(vi) Patients participating in clinical trials or other clinical studies
(vii) Patients who are deemed inappropriate as research subjects by the principal investigator.

Related Information

• Primary Sponsor: Kurata Shinji
• Secondary Sponsor: Fisher & Paykel (Fisher & Paykel Healthcare Limited)