Comparison of High Flow Nasal Oxygen and Nasal Cannula in Burn Patients Under Sedation

NCT06756906 | Recruiting

• 1 other identifier: E2-24-6462
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Burn-related pain is severe and often difficult to manage. Burn patients often require high doses of opioids and anxiolytics. Anesthetic agents used during sedation such as benzodiazepines, propofol and opioids can cause respiratory depression, predisposing patients to hypoventilation and hypoxemia due to airway obstruction. Oxygen is administered to patients with a standard nasal cannula during sedation. High Flow Nasal Oxygen (HFNO) helps to improve the oxygenation of patients with respiratory distress by delivering high flow humidified oxygen through the nasal cannula at a high rate of up to 40-70 liters per minute. The aim of this study was to compare the effects of HFNO and nasal oxygen therapy in preventing hypoxemia in deeply sedated burn patients.

Conditions

Burn Injury; Hypoxia; Sedation

Keywords

HFNO; Sedation; burn injury

Outcome Measures

Primary Outcomes (1)

• Oxygen saturation SpO2 levels of the cases in %

  Each patient will be monitored with an oxygen saturation probe and SpO2 levels of the cases will be recorded before induction of sedation and every 5 minutes, throughout the procedure. Hypoxemia will be detected.

  Oxygen saturation levels will be recorded before induction and every 5 minutes throughout the procedure.

Secondary Outcomes (1)

• Number of interventions over procedure time

  Number of maneuvers performed throughout the procedure.

Other Outcomes (2)

• Systolic, diastolic and mean blood pressures will be recorded in mmHg

  Blood pressure monitorization will be performed induction and every 5 minutes throughout the procedure.

• Heart beat will be recorded in beats per minute

  Heart beat monitorization will be performed before induction and every 5 minutes throughout the procedure.

Study Arms (2)

Group 1: Standard nasal oxygen therapy

Patients will be preoxygenated with 8L/min oxygen and will receive 3L/min oxygen throughout the procedure.

Group 2: High-flow nasal oxygen therapy (HFNO)

Patients who will receive HFNO will be preoxygenated with HFNO 40 l/min with FiO2 100% 3 min before induction. Patients will receive HFNO 50 l/min with FiO2 50% throughout the procedure.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients scheduled for burn treatment under sedation in Ankara City Hospital's Burn Center will be included

You may not qualify if:

• Intubation
• Tracheostomies
• Need for oxygen therapy due to preexisting disease
• Pregnancy

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Service JA, Bain JS, Gardner CP, McNarry AF. Prospective Experience of High-flow Nasal Oxygen During Bronchoscopy in 182 Patients: A Feasibility Study. J Bronchology Interv Pulmonol. 2019 Jan;26(1):66-70. doi: 10.1097/LBR.0000000000000533.

  PMID: 30048415 BACKGROUND

• Khanna P, Haritha D, Das A, Sarkar S, Roy A. Utility of high-flow nasal oxygen in comparison to conventional oxygen therapy during upper gastrointestinal endoscopic procedures under sedation: A systematic review and meta-analyses. Indian J Gastroenterol. 2023 Feb;42(1):53-63. doi: 10.1007/s12664-022-01308-6. Epub 2023 Feb 13.

  PMID: 36780095 BACKGROUND

• Spence EA, Rajaleelan W, Wong J, Chung F, Wong DT. The Effectiveness of High-Flow Nasal Oxygen During the Intraoperative Period: A Systematic Review and Meta-analysis. Anesth Analg. 2020 Oct;131(4):1102-1110. doi: 10.1213/ANE.0000000000005073.

  PMID: 32925331 BACKGROUND

MeSH Terms

Conditions

Burns; Hypoxia

Condition Hierarchy (Ancestors)

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

Study Officials

• Ezgi Erkılıç, Assoc Prof

  Ankara Bilkent City Hospital, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

• Huriye Bilge Tuncer, MD

  Ankara Bilkent City Hospital, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

• Merve Akın, Assoc Prof

  Ankara Bilkent City Hospital, Department of General Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sümeyye Demirhan, MD

CONTACT

+905469353388; dmrhnsmyy@gmail.com

Cihan Doger, Assoc Prof

CONTACT

+905054884195; cihandoger@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. MD

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 3, 2025
• Study Start: July 15, 2024
• Primary Completion: January 27, 2025
• Study Completion: February 10, 2025
• Last Updated: January 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Beginnning right after publication and ending 2 years after the publication of results
• Access Criteria: Data required for research will be shared

Locations

TU (1)