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

NCT ID: NCT06756906

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-15
• Study Completion Date: 2025-02-10

Brief Summary

Burn-related pain is severe and often difficult to manage. Burn patients often require high doses of opioids and anxiolytics. Anesthetic agents used during sedation such as benzodiazepines, propofol and opioids can cause respiratory depression, predisposing patients to hypoventilation and hypoxemia due to airway obstruction. Oxygen is administered to patients with a standard nasal cannula during sedation. High Flow Nasal Oxygen (HFNO) helps to improve the oxygenation of patients with respiratory distress by delivering high flow humidified oxygen through the nasal cannula at a high rate of up to 40-70 liters per minute. The aim of this study was to compare the effects of HFNO and nasal oxygen therapy in preventing hypoxemia in deeply sedated burn patients.

Detailed Description

This research is an observational prospective case-control study conducted in the Burns Center of Ankara Bilkent City Hospital. The aim of the study was to compare standard nasal oxygen therapy with High Flow Nasal Oxygen (HFNO) therapy in terms of hypoxemia in patients undergoing surgery for minor and moderate burns under deep sedation. Volunteer patients over 18 years of age, in the ASA (American Society of Anesthesiology) I-III risk group, who will undergo burn operation will be included in the study. Patients will be informed about the scope of the study, possible risks and benefits before participating in the study, and informed consent will be obtained from all participants by signing the informed consent form.

A total of 70 patients will be included in the study. The study consists of 2 groups. Group 1: Standard nasal oxygen (n:35), Group 2: HFNO (n:35) Before starting induction, patients who will be given nasal oxygen will be preoxygenated with 100% oxygen for 3 min with an oxygen flow rate of 8 l/min. Patients who will receive HFNO will be preoxygenated with HFNO 40 l/min with FiO2 100% 3 min before induction. Patients will be premedicated with 1 mg iv midazolam and 1 mcg/kg fentanyl 1 min before induction. During the induction phase, 1% propofol-ketamine (0.5-1 mg/kg) will be administered and an additional dose of propofol-ketamine will be administered according to the patient's BIS value and the total drug dose will be noted. Non-invasive arterial blood pressure, heart rate, electrocardiogram (ECG), oxygen saturation, SpO2, BIS and NIRS values will be recorded before and every 5 minutes during the procedure. Patient demographics, total procedure time, amount of anesthetic agent used, heart rate and other clinical parameters will also be recorded. Ramsey sedation scale of the patients during the procedure and Aldrete scores at the end of the procedure will be evaluated. In case of apnea or desaturation, maneuvers such as patient stimulation, chin lifting, or increasing oxygen flow were performed and recorded.

The statistical package program SPSS 25.0 (Armonk, NY: IBM Corp.) will be used for data analysis. Descriptive statistics (frequency, percentage, minimum, maximum, mean, standard deviation, median, min-max, IQR) will be used. Pearson chi-square test, Fisher or Yates x2 tests will be used to compare qualitative data. The conformity of the data to normal distribution will be evaluated by Kolmogorov-Smirnov and Shapiro-Wilk tests, skewness-kurtosis and graphical methods (histogram, Q-Q Plot, Stem and Leaf, Boxplot). For normally distributed quantitative data, independent samples t test or one way ANOVA will be applied. For non-normally distributed data, Mann-Whitney U test or Kruskal-Wallis test will be used. Paired t test or Friedman test will be used to compare repeated measures. The relationship between variables will be evaluated by Pearson or Spearmans's Rho Correlation test. P<0.05 will be accepted as statistical significance level.

Conditions

Burn Injury; Hypoxia; Sedation

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1: Standard nasal oxygen therapy

Patients will be preoxygenated with 8L/min oxygen and will receive 3L/min oxygen throughout the procedure.

No interventions assigned to this group

Group 2: High-flow nasal oxygen therapy (HFNO)

Patients who will receive HFNO will be preoxygenated with HFNO 40 l/min with FiO2 100% 3 min before induction. Patients will receive HFNO 50 l/min with FiO2 50% throughout the procedure.

No interventions assigned to this group

Eligibility Criteria

Exclusion Criteria

• Intubation
• Tracheostomies
• Need for oxygen therapy due to preexisting disease
• Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Cihan Döğer

Assoc. Prof. MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ezgi Erkılıç, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Ankara Bilkent City Hospital, Department of Anesthesiology

Huriye Bilge Tuncer, MD

Role: PRINCIPAL_INVESTIGATOR

Ankara Bilkent City Hospital, Department of Anesthesiology

Merve Akın, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Ankara Bilkent City Hospital, Department of General Surgery

Locations

Ankara Bilkent City Hospital

Ankara, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Sümeyye Demirhan, MD

Role: CONTACT

dmrhnsmyy@gmail.com

+905469353388

Cihan Doger, Assoc Prof

Role: CONTACT

cihandoger@gmail.com

+905054884195

References

Service JA, Bain JS, Gardner CP, McNarry AF. Prospective Experience of High-flow Nasal Oxygen During Bronchoscopy in 182 Patients: A Feasibility Study. J Bronchology Interv Pulmonol. 2019 Jan;26(1):66-70. doi: 10.1097/LBR.0000000000000533.

Reference Type: BACKGROUND

PMID: 30048415 (View on PubMed)

Khanna P, Haritha D, Das A, Sarkar S, Roy A. 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. Indian J Gastroenterol. 2023 Feb;42(1):53-63. doi: 10.1007/s12664-022-01308-6. Epub 2023 Feb 13.

Reference Type: BACKGROUND

PMID: 36780095 (View on PubMed)

Spence EA, Rajaleelan W, Wong J, Chung F, Wong DT. The Effectiveness of High-Flow Nasal Oxygen During the Intraoperative Period: A Systematic Review and Meta-analysis. Anesth Analg. 2020 Oct;131(4):1102-1110. doi: 10.1213/ANE.0000000000005073.

Reference Type: BACKGROUND

PMID: 32925331 (View on PubMed)

Other Identifiers

E2-24-6462

Identifier Type: -

Identifier Source: org_study_id