BurnsNCT06663293
Comparison of High Flow vs Standard Nasal Cannula in Children With Burns Under Sedoanalgesia
A study testing Conventional Nasal Cannula, High-flow nasal cannula and midazolam, ketamine, propofol in people with Burns, run by Zeliha Alicikus at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the positive effects of high-flow oxygen therapy on the reduction of airway adverse events and recovery time compared to conventional nasal oxygen therapy in pediatric burns treated with procedural sedoanalgesia. Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Burns
- What is being tested?
- Conventional Nasal Cannula, High-flow nasal cannula and midazolam, ketamine, propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2022to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 year to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 1 and 14 years
- ASA risk groups 1-3
- Second-degree burns covering more than 10% of the total body surface area, or third- and fourth-degree burns covering more than 2% of the total body surface area, burns involving the face, hands, feet, genital area, perineum, or major joints, electrical burns, and chemical burns.
Who cannot join
- Under 1 year of age or over 14 years of age
- ASA score above 3
- Having restrictive or obstructive chronic respiratory diseases, active upper or lower respiratory infections, first-degree burns, and burns to the nasal area or respiratory tract.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Umraniye Education and Research hospital
Istanbul, 34764
About this study
Official title: Comparison of High Flow and Conventional Nasal Cannula Outcomes in Pediatric Burn Patients Under Sedoanalgesia: A Prospective Randomized Study
The aim of this study is to investigate the positive effects of high-flow oxygen therapy on the reduction of airway adverse events and recovery time compared to conventional nasal oxygen therapy in pediatric burns treated with procedural sedoanalgesia.
Read the detailed description
High flow nasal cannula oxygenation (HFNCO) has gained popularity in pediatric anesthesia practice. The basic mechanism of HFNCO involves reducing metabolic cost and work of breathing, decreasing nasopharyngeal resistance, and improving gas conditioning and secretion clearance. Heating and humidifying the oxygen administered make it easier for patients to tolerate high flow. The flow rate can be adjusted for all age groups. However, there are no studies in the literature investigating the effectiveness of HFNCO during procedural sedation in pediatric burn patients.
This randomized prospective study was performed in 50 patients aged 1-14 years in the pediatric burn unit. Patients were divided into two groups as Group HFO: High flow oxygen (n: 25) and Group NC: nasal cannula oxygen (n: 25). Age, sex, burn percentage, concomitant diseases, ASA score, BMI (body mass index), respiratory and hemodynamic parameters, recovery time and presence of complications during sedoanalgesia were recorded.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Nasal CannulaOther
The initial flow rate for nasal cannula oxygen was set at 3 L/min. In cases of hypoxia, the oxygen concentration was adjusted by increasing the flow rate by 1 to 2 L/min.
High-flow nasal cannulaOther
The high-flow nasal oxygenation device was set to a temperature of 36°C and an FiO2 of 0.4. The initial oxygen flow rate for the high flow group was determined according to the age and weight of the patients, based on our pediatric intensive care team's guidelines and the reference from the Slain study. When SpO2 fell below 94%, it was considered hypoxia, and the flow rate was increased by 2 to 4 L/min.
midazolam, ketamine, propofolDrug
Sedation was done with IV midazolam 0.025 to 0.1 mg/kg, IV ketamine 0.25 to 0.5 mg/kg, and IV propofol (1%) 0.25 to 0.5 mg/kg
PropofolDrug
Sedation maintenance was done by propofol 0.5 to 1 mg/kg/h
| Study group | Role | What they receive |
|---|---|---|
| Conventional Nasal Cannula Oxygen group | Placebo comparator | Participants received low flow oxygen therapy through a conventional nasal cannula. The initial flow rate for nasal cannula oxygen was set at 3 L/min. In cases of hypoxia, the oxygen concentration was adjusted by increasing the flow rate by 1 to 2 L/min. Receives: Other: Conventional Nasal Cannula; Drug: midazolam, ketamine, propofol; Drug: Propofol |
| High-flow Nasal Cannula Oxygen Group | Active comparator | Participants received nasal high flow therapy delivered by AIRVO™ 2 (Fisher and Paykel Healthcare Systems, New Zealand) along with single-use nasal oxygen cannulas. Receives: Other: High-flow nasal cannula; Drug: midazolam, ketamine, propofol; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate in beats per minute
Heart rate in beats per minute using ECG leads will be measured intraoperatively and postoperatively
Measured: Intraoperative measurements will be taken at 0, 5, 15, 20 minutes and Postoperative measurements will be taken at 0, 5, and 10 minutes
Respiratory rate in breaths per minute
Respiratory rate in breaths per minute will be measured intraoperatively and post-operatively
Measured: Intraoperative measurements will be taken at 0, 5, 15, 20 minutes and Postoperative measurements will be taken at 0, 5, and 10 minutes
SpO2 in percentage
SpO2 in percentage will be measured intraoperatively and post-operatively
Measured: Intraoperative measurements will be taken at 0, 5, 15, 20 minutes and Postoperative measurements will be taken at 0, 5, and 10 minutes
End-tidal CO2 in mmHg
End-tidal CO2 in mmHg will be measured intraoperatively and post-operatively
Measured: Intraoperative measurements will be taken at 0, 5, 15, 20 minutes and Postoperative measurements will be taken at 0, 5, 10 minutes and at recovery time60 minutes
Oxygen flow levels in Liters per minute
Oxygen flow levels in Liters per minute will be measured intraoperatively
Measured: Intraoperative measurements will be taken at 0, 5, 15, 20 minutes
Secondary outcomes (2)
Need for oxygen assessed by SpO2
Need for oxygen assessed by SpO2 measured in percentage intraoperatively and post-operatively. SpO2 <94% is considered desaturation
Measured: Intraoperative measurements will be taken at 0, 5, 15, 20 minutes and Postoperative measurements will be taken at 0, 5, and 10 minutes
Need for oxygen assessed by Near-Infrared Spectroscopy (NIRS)
Need for oxygen assessed by Near-Infrared Spectroscopy (NIRS) measured intraoperatively. 20% drop from the individual's baseline will be considered desaturation
Measured: Intraoperative measurements will be taken at 0, 5, 15, 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start10 Mar 2022
- Primary completion30 Aug 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 50 patients aged 1-14 years in the pediatric burn unit were divided into two groups as Group HFO: High flow oxygen (n: 25) and Group NC: nasal cannula oxygen (n: 25). The high flow group received nasal high flow therapy delivered by AIRVO™ 2 (Fisher and Paykel Healthcare Systems, New Zealand) along with single-use nasal oxygen cannulas. The HFNCO device was set to a temperature of 36°C and an FiO2 of 0.4. The initial oxygen flow rate for the high flow group was determined according to the age and weight of the patients, based on our pediatric intensive care team's guidelines and the reference from the Slain NK (10) study. When SpO2 fell below 94%, it was considered hypoxia, and the flow rate was increased by 2 to 4 L/min. For the low flow group, the initial flow rate for nasal cannula oxygen was set at 3 L/min. In cases of hypoxia, the oxygen concentration was adjusted by increasing the flow rate by 1 to 2 L/min.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeliha Alicikus
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Zeliha Alicikus, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663293
- Sponsor's protocol ID
- B.10.1.TKH.4.34.H.GP.0.01-93
- Status last verified
- Nov 2025
- First submitted
- 17 Oct 2024
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of High Flow and Conventional Nasal Cannula Outcomes in Pediatric Burn Patients Under Sedoanalgesia: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT06663293
- Acronym / sponsor ID
- B.10.1.TKH.4.34.H.GP.0.01-93
- Conditions
- Burns
- Keywords
- Pediatrics, Burn, Sedo-analgesia, Oxygen therapy, High flow Nasal Oxygen, Hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Zeliha AlicikusOther government
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 29 Oct 2024 (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.
The aim of this study is to investigate the positive effects of high-flow oxygen therapy on the reduction of airway adverse events and recovery time compared to conventional nasal oxygen therapy in pediatric burns treated with procedural sedoanalgesia.
Detailed description
High flow nasal cannula oxygenation (HFNCO) has gained popularity in pediatric anesthesia practice. The basic mechanism of HFNCO involves reducing metabolic cost and work of breathing, decreasing nasopharyngeal resistance, and improving gas conditioning and secretion clearance. Heating and humidifying the oxygen administered make it easier for patients to tolerate high flow. The flow rate can be adjusted for all age groups. However, there are no studies in the literature investigating the effectiveness of HFNCO during procedural sedation in pediatric burn patients.
This randomized prospective study was performed in 50 patients aged 1-14 years in the pediatric burn unit. Patients were divided into two groups as Group HFO: High flow oxygen (n: 25) and Group NC: nasal cannula oxygen (n: 25). Age, sex, burn percentage, concomitant diseases, ASA score, BMI (body mass index), respiratory and hemodynamic parameters, recovery time and presence of complications during sedoanalgesia were recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 50 patients aged 1-14 years in the pediatric burn unit were divided into two groups as Group HFO: High flow oxygen (n: 25) and Group NC: nasal cannula oxygen (n: 25). The high flow group received nasal high flow therapy delivered by AIRVO™ 2 (Fisher and Paykel Healthcare Systems, New Zealand) along with single-use nasal oxygen cannulas. The HFNCO device was set to a temperature of 36°C and an FiO2 of 0.4. The initial oxygen flow rate for the high flow group was determined according to the age and weight of the patients, based on our pediatric intensive care team's guidelines and the reference from the Slain NK (10) study. When SpO2 fell below 94%, it was considered hypoxia, and the flow rate was increased by 2 to 4 L/min. For the low flow group, the initial flow rate for nasal cannula oxygen was set at 3 L/min. In cases of hypoxia, the oxygen concentration was adjusted by increasing the flow rate by 1 to 2 L/min.
| Arm | Type | Receives |
|---|---|---|
| Conventional Nasal Cannula Oxygen group | Placebo comparator | Other: Conventional Nasal Cannula, Drug: midazolam, ketamine, propofol, Drug: PropofolParticipants received low flow oxygen therapy through a conventional nasal cannula. The initial flow rate for nasal cannula oxygen was set at 3 L/min. In cases of hypoxia, the oxygen concentration was adjusted by increasing the flow rate by 1 to 2 L/min. |
| High-flow Nasal Cannula Oxygen Group | Active comparator | Other: High-flow nasal cannula, Drug: midazolam, ketamine, propofol, Drug: PropofolParticipants received nasal high flow therapy delivered by AIRVO™ 2 (Fisher and Paykel Healthcare Systems, New Zealand) along with single-use nasal oxygen cannulas. |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age: 1 and 14 years
- ASA risk groups 1-3
- Second-degree burns covering more than 10% of the total body surface area, or third- and fourth-degree burns covering more than 2% of the total body surface area, burns involving the face, hands, feet, genital area, perineum, or major joints, electrical burns, and chemical burns.
Key exclusion criteria (3 listed)
- Under 1 year of age or over 14 years of age
- ASA score above 3
- Having restrictive or obstructive chronic respiratory diseases, active upper or lower respiratory infections, first-degree burns, and burns to the nasal area or respiratory tract.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Nasal CannulaThe initial flow rate for nasal cannula oxygen was set at 3 L/min. In cases of hypoxia, the oxygen concentration was adjusted by increasing the flow rate by 1 to 2 L/min. | Other | Conventional Nasal Cannula Oxygen group |
| High-flow nasal cannulaThe high-flow nasal oxygenation device was set to a temperature of 36°C and an FiO2 of 0.4. The initial oxygen flow rate for the high flow group was determined according to the age and weight of the patients, based on our pediatric intensive care team's guidelines and the reference from the Slain study. When SpO2 fell below 94%, it was considered hypoxia, and the flow rate was increased by 2 to 4 L/min. | Other | High-flow Nasal Cannula Oxygen Group |
| midazolam, ketamine, propofolSedation was done with IV midazolam 0.025 to 0.1 mg/kg, IV ketamine 0.25 to 0.5 mg/kg, and IV propofol (1%) 0.25 to 0.5 mg/kg | Drug | Conventional Nasal Cannula Oxygen group, High-flow Nasal Cannula Oxygen Group |
| PropofolSedation maintenance was done by propofol 0.5 to 1 mg/kg/h | Drug | Conventional Nasal Cannula Oxygen group, High-flow Nasal Cannula Oxygen Group |
Primary outcome
Heart rate in beats per minute
Time frame: Intraoperative measurements will be taken at 0, 5, 15, 20 minutes and Postoperative measurements will be taken at 0, 5, and 10 minutes
Heart rate in beats per minute using ECG leads will be measured intraoperatively and postoperatively
Respiratory rate in breaths per minute
Time frame: Intraoperative measurements will be taken at 0, 5, 15, 20 minutes and Postoperative measurements will be taken at 0, 5, and 10 minutes
Respiratory rate in breaths per minute will be measured intraoperatively and post-operatively
SpO2 in percentage
Time frame: Intraoperative measurements will be taken at 0, 5, 15, 20 minutes and Postoperative measurements will be taken at 0, 5, and 10 minutes
SpO2 in percentage will be measured intraoperatively and post-operatively
End-tidal CO2 in mmHg
Time frame: Intraoperative measurements will be taken at 0, 5, 15, 20 minutes and Postoperative measurements will be taken at 0, 5, 10 minutes and at recovery time60 minutes
End-tidal CO2 in mmHg will be measured intraoperatively and post-operatively
Oxygen flow levels in Liters per minute
Time frame: Intraoperative measurements will be taken at 0, 5, 15, 20 minutes
Oxygen flow levels in Liters per minute will be measured intraoperatively
2 secondary outcomes
Need for oxygen assessed by SpO2
Time frame: Intraoperative measurements will be taken at 0, 5, 15, 20 minutes and Postoperative measurements will be taken at 0, 5, and 10 minutes
Need for oxygen assessed by Near-Infrared Spectroscopy (NIRS)
Time frame: Intraoperative measurements will be taken at 0, 5, 15, 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Nasal Cannula, High-flow nasal cannula and midazolam, ketamine, propofol in people with Burns, run by Zeliha Alicikus 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 19 Nov 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate in beats per minute (time frame: Intraoperative measurements will be taken at 0, 5, 15, 20 minutes and Postoperative measurements will be taken at 0, 5, and 10 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2025.