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Trials / Completed

CompletedNCT06663293

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
50 (actual)
Sponsor
Zeliha Alicikus · Other Government
Sex
All
Age
1 Year – 14 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERConventional 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.
OTHERHigh-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.
DRUGmidazolam, 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
DRUGPropofolSedation maintenance was done by propofol 0.5 to 1 mg/kg/h

Timeline

Start date
2022-03-10
Primary completion
2022-08-30
Completion
2022-10-01
First posted
2024-10-29
Last updated
2025-11-19

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06663293. Inclusion in this directory is not an endorsement.