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Completed

NCT Number: NCT06663293

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

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.

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Key information

Age range

1 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Umraniye Education and Research hospital

Istanbul, 34764, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conventional Nasal Cannula

Other

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

Other

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, propofol

Drug

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

Propofol

Drug

Sedation maintenance was done by propofol 0.5 to 1 mg/kg/h

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. 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 SpO2 measured in percentage intraoperatively and post-operatively. SpO2 <94% is considered desaturation

  2. Need for oxygen assessed by Near-Infrared Spectroscopy (NIRS)

    Time frame: Intraoperative measurements will be taken at 0, 5, 15, 20 minutes

    Need for oxygen assessed by Near-Infrared Spectroscopy (NIRS) measured intraoperatively. 20% drop from the individual's baseline will be considered desaturation

Sponsors and collaborators

Lead sponsor

Zeliha Alicikus

Other Gov

Registry information

Official study title

Comparison of High Flow and Conventional Nasal Cannula Outcomes in Pediatric Burn Patients Under Sedoanalgesia: A Prospective Randomized Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 29, 2024
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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