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Clinical Trials/NCT06663293
NCT06663293
Completed
Not Applicable

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

Zeliha Alicikus1 site in 1 country50 target enrollmentMarch 10, 2022

Overview

Phase
Not Applicable
Intervention
Conventional Nasal Cannula
Conditions
Burns
Sponsor
Zeliha Alicikus
Enrollment
50
Locations
1
Primary Endpoint
Heart rate in beats per minute
Status
Completed
Last Updated
5 months ago

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.

Registry
clinicaltrials.gov
Start Date
March 10, 2022
End Date
October 1, 2022
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Zeliha Alicikus
Responsible Party
Sponsor Investigator
Principal Investigator

Zeliha Alicikus

Study Director

Umraniye Education and Research Hospital

Eligibility Criteria

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

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

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

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

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

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

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)

Study Sites (1)

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