Comparison of High Flow and Conventional Nasal Cannula Outcomes in Pediatric Burn Patients Under Sedoanalgesia: A Prospective Randomized Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Heart rate in beats per minute
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 1 Year to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Conventional Nasal Cannula (Other)
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.
Intervention: midazolam, ketamine, propofol (Drug)
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.
Intervention: Propofol (Drug)
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.
Intervention: High-flow nasal cannula (Other)
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.
Intervention: midazolam, ketamine, propofol (Drug)
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.
Intervention: Propofol (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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 Near-Infrared Spectroscopy (NIRS)(Intraoperative measurements will be taken at 0, 5, 15, 20 minutes)
Investigators
Zeliha Alicikus
Study Director
Umraniye Education and Research Hospital