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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06205212
Other study ID # HFNO_PRE
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 10, 2023
Est. completion date October 10, 2024

Study information

Verified date September 2023
Source Seoul National University Hospital
Contact TAE KYONG KIM
Phone 82-2-870-2519
Email ktkktk@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Atelectasis after induction of general anesthesia is common even in healthy patients and is clinically problematic, especially in obese patients. We aim to investigate whether preoxygenation with high-flow nasal oxygen during anesthesia induction reduces atelectasis in obese patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 92
Est. completion date October 10, 2024
Est. primary completion date October 10, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults patients undergoinig surgery under general anesthesia with a BMI of 30 kg/m2 or greater who have given informed consent Exclusion Criteria: - surgery time less than 2 hours - Nasotracheal intubation - Severe cardiac or respiratory disease - History of difficult airway - History of a surgery or anatomical anomaly in the head and neck - History of Inability to breathe through nose - Gastric reflux disease

Study Design


Related Conditions & MeSH terms


Intervention

Other:
high-flow nasal oxygen
preoxygenation using high-flow nasal oxygen, FiO2 1.0, 40 L/min, 3 min
facemask
preoxygenation using facemask, FIO2 1.0, fresh gas flow 10 L/min, 3 min

Locations

Country Name City State
Korea, Republic of SMG - SNU Boramae Medical Center Seoul

Sponsors (2)

Lead Sponsor Collaborator
Seoul National University Hospital SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lung ultrasound score modified LUSS Immediately after anesthesia induction
Secondary Incidence of atelectasis Immediately after anesthesia induction
Secondary PaO2 to FiO2 ratio and PaCO2 Immediately after anesthesia induction
Secondary Hemodynamic variables Blood pressure, heart rate, pulse oximetry During anesthesia induction
Secondary Patient Satisfaction Score During preoxygenation
Secondary Lung ultrasound score In the PACU after surgery
Secondary Incidence of Spo2 less than 95% during 48 hours postoperatively
Secondary Maximum body temperature during hospitalization up to 1 week
Secondary Incidence of postoperative pulmonary complications during hospitalization up to 1 week
Secondary length of hospital stay up to 1 year
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