High-flow Nasal Oxygenation During Preoxygenation and Atelectasis

January 3, 2024 updated by: Seoul National University Hospital

The Effect of High-flow Nasal Cannula Applied During Preoxygenation for Prevention of Atelectasis in Patients With Obesity Undergoing General Anesthesia: A Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 07061
        • Recruiting
        • SMG - SNU Boramae Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: facemask
preoxygenation using a conventional facemask
Other: facemask
preoxygenation using facemask, FIO2 1.0, fresh gas flow 10 L/min, 3 min
Experimental: high-flow nasal oxygen
preoxygenation using high-flow nasal cannula oxygen
Other: high-flow nasal oxygen
preoxygenation using high-flow nasal oxygen, FiO2 1.0, 40 L/min, 3 min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung ultrasound score
Time Frame: Immediately after anesthesia induction
modified LUSS
Immediately after anesthesia induction

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

SMG-SNU Boramae Medical Center

Investigators

  • Principal Investigator: TAE KYONG KIM, SMG-SNU Boramae Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2023

Primary Completion (Estimated)

October 10, 2024

Study Completion (Estimated)

October 10, 2024

Study Registration Dates

First Submitted

September 19, 2023

First Submitted That Met QC Criteria

January 3, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HFNO_PRE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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