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

NCT06663293 | Completed

• 1 other identifier: B.10.1.TKH.4.34.H.GP.0.01-93
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Keywords

Pediatrics; Burn; Sedo-analgesia; Oxygen therapy; High flow Nasal Oxygen; Hypoxia

Outcome Measures

Primary Outcomes (5)

• Heart rate in beats per minute

  Heart rate in beats per minute using ECG leads will be measured intraoperatively and postoperatively

  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

  Respiratory rate in breaths per minute will be measured intraoperatively and post-operatively

  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

  SpO2 in percentage will be measured intraoperatively and post-operatively

  Intraoperative measurements will be taken at 0, 5, 15, 20 minutes and Postoperative measurements will be taken at 0, 5, and 10 minutes

• End-tidal CO2 in mmHg

  End-tidal CO2 in mmHg will be measured intraoperatively and post-operatively

  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

• Oxygen flow levels in Liters per minute

  Oxygen flow levels in Liters per minute will be measured intraoperatively

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

Secondary Outcomes (2)

• 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 Arms (2)

Conventional Nasal Cannula Oxygen group

PLACEBO COMPARATOR

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.

Other: Conventional Nasal Cannula; Drug: midazolam, ketamine, propofol; Drug: Propofol

High-flow Nasal Cannula Oxygen Group

ACTIVE COMPARATOR

Participants received nasal high flow therapy delivered by AIRVO™ 2 (Fisher and Paykel Healthcare Systems, New Zealand) along with single-use nasal oxygen cannulas.

Other: High-flow nasal cannula; Drug: midazolam, ketamine, propofol; Drug: Propofol

Interventions

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.

Conventional Nasal Cannula Oxygen group

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.

High-flow Nasal Cannula Oxygen Group

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

Conventional Nasal Cannula Oxygen group; High-flow Nasal Cannula Oxygen Group

Propofol DRUG

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

Conventional Nasal Cannula Oxygen group; High-flow Nasal Cannula Oxygen Group

Eligibility Criteria

• Age: 1 Year - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zeliha Alicikus: lead

Study Sites (1)

Umraniye Education and Research hospital

Istanbul, 34764, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Burns; Hypoxia

Interventions

Midazolam; Ketamine; Propofol

Condition Hierarchy (Ancestors)

Wounds and Injuries; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Director

Model Details: 50 patients aged 1-14 years in the pediatric burn unit were divided into two groups as Group HFO: High flow oxygen (n: 25) and Group NC: nasal cannula oxygen (n: 25). The high flow group received nasal high flow therapy delivered by AIRVO™ 2 (Fisher and Paykel Healthcare Systems, New Zealand) along with single-use nasal oxygen cannulas. The HFNCO 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 NK (10) study. When SpO2 fell below 94%, it was considered hypoxia, and the flow rate was increased by 2 to 4 L/min. For the low flow group, 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.

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 29, 2024
• Study Start: March 10, 2022
• Primary Completion: August 30, 2022
• Study Completion: October 1, 2022
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)