Comparison of High Flow vs Standard Nasal Cannula in Children With Burns Under Sedoanalgesia

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.

Study Overview

• Status: Completed
• Conditions: Burns
• Intervention / Treatment: Other: Conventional Nasal Cannula; Other: High-flow nasal cannula; Drug: midazolam, ketamine, propofol; Drug: Propofol

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye), 34764
    • Umraniye Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Conventional Nasal Cannula Oxygen group; 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.	Other: 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.; Drug: midazolam, ketamine, propofol; 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; Drug: Propofol; Sedation maintenance was done by propofol 0.5 to 1 mg/kg/h
Active Comparator: High-flow Nasal Cannula Oxygen Group; Participants received nasal high flow therapy delivered by AIRVO™ 2 (Fisher and Paykel Healthcare Systems, New Zealand) along with single-use nasal oxygen cannulas.	Other: High-flow nasal cannula; 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.; Drug: midazolam, ketamine, propofol; 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; Drug: Propofol; Sedation maintenance was done by propofol 0.5 to 1 mg/kg/h

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate in beats per minute	Heart rate in beats per minute using ECG leads will be measured intraoperatively and postoperatively	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	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	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	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	Intraoperative measurements will be taken at 0, 5, 15, 20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Intraoperative measurements will be taken at 0, 5, 15, 20 minutes
Need for oxygen assessed by SpO2	Need for oxygen assessed by SpO2 measured in percentage intraoperatively and post-operatively. SpO2 <94% is considered desaturation	Intraoperative measurements will be taken at 0, 5, 15, 20 minutes and Postoperative measurements will be taken at 0, 5, and 10 minutes

Collaborators and Investigators

• Sponsor: Zeliha Alicikus

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2022
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: October 17, 2024
• First Submitted That Met QC Criteria: October 26, 2024
• First Posted (Actual): October 29, 2024

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Hypoxia; Pediatrics; Oxygen therapy; Burn; Sedo-analgesia; High flow Nasal Oxygen
• Additional Relevant MeSH Terms: Wounds and Injuries; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hypoxia; Burns; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Benzazepines; Benzodiazepines; Midazolam; Propofol; Ketamine
• Other Study ID Numbers: B.10.1.TKH.4.34.H.GP.0.01-93

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No