Comparison of High Flow Vs Standard Nasal Cannula in Children with Burns Under Sedoanalgesia
- Conditions
- Burns
- Interventions
- Other: Conventional Nasal CannulaOther: High-flow nasal cannula
- Registration Number
- NCT06663293
- Lead Sponsor
- Zeliha Tuncel
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional Nasal Cannula Oxygen group Conventional Nasal Cannula 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. Conventional Nasal Cannula Oxygen group midazolam, ketamine, propofol 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. Conventional Nasal Cannula Oxygen group Propofol 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. High-flow Nasal Cannula Oxygen Group High-flow nasal cannula Participants received nasal high flow therapy delivered by AIRVO™ 2 (Fisher and Paykel Healthcare Systems, New Zealand) along with single-use nasal oxygen cannulas. High-flow Nasal Cannula Oxygen Group midazolam, ketamine, propofol Participants received nasal high flow therapy delivered by AIRVO™ 2 (Fisher and Paykel Healthcare Systems, New Zealand) along with single-use nasal oxygen cannulas. High-flow Nasal Cannula Oxygen Group Propofol Participants received nasal high flow therapy delivered by AIRVO™ 2 (Fisher and Paykel Healthcare Systems, New Zealand) along with single-use nasal oxygen cannulas.
- Primary Outcome Measures
Name Time Method Heart rate in beats per minute 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 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 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 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 Intraoperative measurements will be taken at 0, 5, 15, 20 minutes Oxygen flow levels in Liters per minute will be measured intraoperatively
- Secondary Outcome Measures
Name Time Method Need for oxygen assessed by SpO2 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
Need for oxygen assessed by Near-Infrared Spectroscopy (NIRS) 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
Trial Locations
- Locations (1)
Umraniye Education and Research hospital
🇹🇷Istanbul, Turkey