Actively Recruiting

Age: 18Years +
All Genders
ID06756906

Comparison of High Flow Nasal Oxygen and Standard Nasal Oxygen Therapy in Preventing Hypoxia in Minor and Moderate Burn Patients Under Sedation

Led by Ankara City Hospital Bilkent · Updated on 2025-01-03

70

Participants Needed

1

Research Sites

2 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating oxygen therapies in adult burn patients undergoing surgery under deep sedation to prevent low oxygen levels (hypoxemia). This observational prospective case-control study compares the effects of standard nasal oxygen therapy and High Flow Nasal Oxygen (HFNO) therapy in patients with minor to moderate burns. The study includes volunteers over 18 years old, classified within ASA risk groups I-III, treated at a burns center in Ankara Bilkent City Hospital. The study involves two groups: one receiving standard nasal oxygen therapy and the other receiving HFNO. Patients in the standard group are preoxygenated with 100% oxygen at 8 liters per minute for 3 minutes, then receive 3 liters per minute during the procedure. The HFNO group is preoxygenated with 100% oxygen at 40 liters per minute for 3 minutes and receives HFNO at 50 liters per minute with 50% oxygen throughout the procedure. Sedation includes medications such as midazolam, fentanyl, and propofol-ketamine, with doses adjusted based on sedation monitoring. Participants will be monitored continuously for oxygen saturation, heart rate, blood pressure, and sedation levels before and every 5 minutes during the procedure. Researchers will record anesthetic doses, procedure duration, and any interventions needed to manage apnea or desaturation. Sedation quality and recovery scores will also be evaluated. The main outcome is oxygen saturation levels, with secondary outcomes including the number of interventions performed during sedation. Data will be statistically analyzed to compare the two oxygen therapies.

CONDITIONS

Brief Title

Comparison of High Flow Nasal Oxygen and Nasal Cannula in Burn Patients Under Sedation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntary patients over 18 years of age
  • ASA (American Society of Anesthesiologists) risk scores I to III
  • Patients undergoing surgery for minor or moderate burns
Not Eligible

You will not qualify if you...

  • Patients who are intubated
  • Patients with tracheostomies
  • Patients requiring oxygen therapy due to a preexisting disease
  • Pregnant patients

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Duration of the surgical procedure

Participants undergoing burn surgery under sedation will be monitored for oxygen saturation and clinical parameters before and throughout the procedure.

Continuous monitoring during the procedure

Trial Site Locations

Total: 1 location

1

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye), 06800

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Research Team

S

Sümeyye Demirhan, MD

C

Cihan Doger, Assoc Prof

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Prospective Experience of High-flow Nasal Oxygen During Bronchoscopy in 182 Patients: A Feasibility Study.

Jennifer A Service, Jennifer S Bain, Clare P Gardner...

https://pubmed.ncbi.nlm.nih.gov/30048415

Utility of high-flow nasal oxygen in comparison to conventional oxygen therapy during upper gastrointestinal endoscopic procedures under sedation: A systematic review and meta-analyses.

Puneet Khanna, Damarla Haritha, Aditi Das...

https://pubmed.ncbi.nlm.nih.gov/36780095

The Effectiveness of High-Flow Nasal Oxygen During the Intraoperative Period: A Systematic Review and Meta-analysis.

Emily A Spence, Wesley Rajaleelan, Jean Wong...

https://pubmed.ncbi.nlm.nih.gov/32925331