Burn InjuryNCT06756906
Comparison of High Flow Nasal Oxygen and Nasal Cannula in Burn Patients Under Sedation
An observational study of Burn Injury and Hypoxia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn Injury, Hypoxia, Sedation
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2024to 10 Feb 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for burn treatment under sedation in Ankara City Hospital's Burn Center will be included
Who may be able to join
None listed.
Who cannot join
- Intubation
- Tracheostomies
- Need for oxygen therapy due to preexisting disease
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara, 06800
About this study
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
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.
Read the 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
- Keywords
- HFNO, Sedation, burn injury
- Medical subject headings
- Burns, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Standard nasal oxygen therapy | Patients will be preoxygenated with 8L/min oxygen and will receive 3L/min oxygen throughout the procedure. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen saturation SpO2 levels of the cases in %
Each patient will be monitored with an oxygen saturation probe and SpO2 levels of the cases will be recorded before induction of sedation and every 5 minutes, throughout the procedure. Hypoxemia will be detected.
Measured: Oxygen saturation levels will be recorded before induction and every 5 minutes throughout the procedure.
Secondary outcomes (1)
Number of interventions over procedure time
In case of apnea or desaturation, airway interventions will be performed and recorded throughout the procedure.
Measured: Number of maneuvers performed throughout the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start15 Jul 2024
- Primary completion27 Jan 2025 (estimated)
- Study completion10 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Burn InjuryStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cihan Döğer, Ankara City Hospital Bilkent
- Investigators
- Ezgi Erkılıç, Assoc Prof, Principal investigator, Ankara Bilkent City Hospital, Department of AnesthesiologyHuriye Bilge Tuncer, MD, Principal investigator, Ankara Bilkent City Hospital, Department of AnesthesiologyMerve Akın, Assoc Prof, Principal investigator, Ankara Bilkent City Hospital, Department of General Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756906
- Sponsor's protocol ID
- E2-24-6462
- Status last verified
- Dec 2024
- First submitted
- 24 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Date will be shared after publication of the study.
Publications
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.
PubMed 30048415Khanna 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.
PubMed 36780095Spence 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.
PubMed 32925331
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06756906
- Acronym / sponsor ID
- E2-24-6462
- Conditions
- Burn Injury, Hypoxia, Sedation
- Keywords
- HFNO, Sedation, burn injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 27 Jan 2025 (estimated)
- Study completion
- 10 Feb 2025 (estimated)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Standard nasal oxygen therapy | – | –Patients will be preoxygenated with 8L/min oxygen and will receive 3L/min oxygen throughout the procedure. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for burn treatment under sedation in Ankara City Hospital's Burn Center will be included
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Intubation
- Tracheostomies
- Need for oxygen therapy due to preexisting disease
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oxygen saturation SpO2 levels of the cases in %
Time frame: Oxygen saturation levels will be recorded before induction and every 5 minutes throughout the procedure.
Each patient will be monitored with an oxygen saturation probe and SpO2 levels of the cases will be recorded before induction of sedation and every 5 minutes, throughout the procedure. Hypoxemia will be detected.
1 secondary outcome
Number of interventions over procedure time
Time frame: Number of maneuvers performed throughout the procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Background: PubMed 30048415Service 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.
- Background: PubMed 36780095Khanna 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.
- Background: PubMed 32925331Spence 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.
- Individual participant dataSharing planned: Yes. Date will be shared after publication of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ezgi Erkılıç, Assoc Prof principal investigator
Ankara Bilkent City Hospital, Department of Anesthesiology
Huriye Bilge Tuncer, MD principal investigator
Ankara Bilkent City Hospital, Department of Anesthesiology
Merve Akın, Assoc Prof principal investigator
Ankara Bilkent City Hospital, Department of General Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burn Injury and Hypoxia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sümeyye Demirhan, MD (+905469353388, dmrhnsmyy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen saturation SpO2 levels of the cases in % (time frame: Oxygen saturation levels will be recorded before induction and every 5 minutes throughout the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06756906, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.