A study on respiratory management in acute postoperative period by Nasal High Flow for patients undergoing surgery under general anesthesia

JRCT ID: jRCTs072200018

Registered date:23/06/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Oral maxillofacial disease
• Date of first enrollment: 27/03/2023
• Target sample size: 48
• Study type: Interventional

Intervention(s)

NHF equipment with air administration group
respiratory management without device group
Face mask with oxygen administration group

Outcome(s)

Primary Outcome

1) Time-weighted average value of tcpO2 (average partial pressure during the observation period)
2) Time-weighted average value of tcpCO2 (average partial pressure during observation period)
3) SpO2 time-weighted average (average oxygen saturation during observation period)
4) respiratory rate time-weighted average (average respiratory rate during observation period)
5) The rate of occurrence of remarkably high CO2 blood serum in which tcpCO2 is 60 mmHg or more (equivalent to PaCO2> 55 mmHg) for 5 minutes or more
6) Incidence rate of moderate hyper CO2 blood with tcpCO2 of 50mmHg or more (equivalent to PaCO2> 45mmHg)
7) SpO2 decreased to 90% or less, requiring oxygen administration

• Secondary Outcome: none

Key inclusion & exclusion criteria

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

Include criteria

1 Age: Adult patients aged 18 to 85 years of age at the time of consent acquisition
2 Gender: Any question
3 hospitalization / outpatient: hospitalization only
4 Patients who received written consent by their own free will after thorough understanding before participating in this study

Exclude criteria

1) Patients who have already been receiving continuous oxygen (home oxygen therapy) by nasal cannula
2) Patients who cannot breathe nose
3) Patients who cannot reduce or discontinue antithrombotic drugs after surgery
4) Patients with a history of pneumothorax
5) Patients who need to administer drugs for pain control after surgery
6) Patients with significant postoperative morphological changes such as extensive resection of the jawbone
7) Other patients judged by the investigator to be inappropriate as study subjects
8) Patients who are positive for the new coronavirus (SARS-CoV-2) PCR test

Related Information

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