Clinical trial NCT06756906: Comparison of High Flow Nasal Oxygen and Nasal Cannula in Burn Patients Under Sedation
Official title: Comparison of the Effects of High Flow Nasal Oxygen and Standard Nasal Oxygen Therapy in Preventing Hypoxia in Minor and Moderate Burn Patients Treated Under Sedation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Burn Injury
Hypoxia
Sedation
Keywords: HFNO
Sedation
burn injury
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for burn treatment under sedation in Ankara City Hospital's Burn Center will be included

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.

Eligibility criteria: Inclusion Criteria : Voluntary patients over 18 years of age -ASA(American Society of Anaesthesiologists) I-III risk scores Exlusion Criteria

Exclusion Criteria:

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

Primary outcomes:
measure: Oxygen saturation SpO2 levels of the cases in %
timeFrame: Oxygen saturation levels will be recorded before induction and every 5 minutes throughout the procedure.
Secondary outcomes:
measure: Number of interventions over procedure time
timeFrame: Number of maneuvers performed throughout the procedure.
Other outcomes:
measure: Systolic, diastolic and mean blood pressures will be recorded in mmHg
timeFrame: Blood pressure monitorization will be performed induction and every 5 minutes throughout the procedure.
measure: Heart beat will be recorded in beats per minute
timeFrame: Heart beat monitorization will be performed before induction and every 5 minutes throughout the procedure.
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
Study officials:
affiliation: Ankara Bilkent City Hospital, Department of Anesthesiology
name: Ezgi Erkılıç, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara Bilkent City Hospital, Department of Anesthesiology
name: Huriye Bilge Tuncer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara Bilkent City Hospital, Department of General Surgery
name: Merve Akın, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.