Comparison of High-Flow Nasal Cannula Oxygen Application and Classic Nasal Cannula Oxygen Application

NCT04472273 | Unknown

• 1 other identifier: U1111-1253-6757
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Recently, sedation practices have increased for diagnostic and interventional procedures for children in non-operating rooms. On the other hand, the rate of respiratory complications especially in non-operating room sedation applications is quite high. Oxygen therapy in sedation applied to non-operating room endoscopy patients is mostly performed with classical nasal cannula. However, recently, the use of High-flow nasal cannula oxygen therapy has been increasing. According to the classical nasal cannula oxygen therapy application where non-moistened oxygen is applied in high-flow nasal cannula oxygen therapy applications where heated and humidified oxygen can be delivered, oxygen therapy can be applied at a flow rate of 25L / min. This method has many advantages. Some of those; makes it possible to provide high flows easily, prevents the airway epithelium from drying out and improves mucus cleansing, causing a decrease in anatomical dead space. It provides discharge of expired air in the upper airways. It reduces the respiration of gas with high CO2 and decreased O2. It increases alveolar ventilation. It is easy to use and increases patient comfort. It offers a stream adjusted to all children. Flow and titration can be adjusted according to the child's weight and effect. Physiological evidence in the pediatric population indicates that flows equal to or higher than 2 L / kg / min produce clinically significant pharyngeal pressure, improve breathing and accelerate the emptying of the respiratory muscles. Because of all these features, high-flow nasal cannula oxygen therapy application is used safely in pediatric patients. In general, it is reported that in non-operating room anesthesia, sedation or anesthesia applied in pediatric patients causes undesirable effects by 20%, most of them (5.5%) have respiratory complications and bradycardia due to hypoxemia. In this study, we aimed to compare the respiratory and hemodynamic results of high-flow nasal cannula oxygen application, which is routinely used in sedation applications in the pediatric endoscopy unit of our hospital, with the classical nasal cannula oxygen therapy application.

Conditions

Sedation Complication

Keywords

high-flow oxygen therapy; pediatric outpatients; sedation

Outcome Measures

Primary Outcomes (1)

• Comparison of the effects of high-flow nasal cannula oxygen administration and nasal cannula oxygen administration on respiratory parameters in patients undergoing sedation in the pediatric endoscopy unit.

  SpO2 and ETCO2 are recorded as data in patients in high-flow nasal cannula and classical nasal cannula oxygen therapy applications.

  SpO2 values of patients at admission, 1 minute, 5 minutes, 10 minutes, 15 minutes and 20 minutes will be recorded. After the procedure, SpO2 and ETCO2 values at the input, 1 minute, 5 minutes, 10 minutes, 15 minutes and 20 minutes will be recorded.

Secondary Outcomes (1)

• Comparison of the effects of high flow nasal cannula oxygen administration and nasal cannula oxygen administration on hemodynamic parameters in patients undergoing sedation in the pediatric endoscopy unit.

  HR and blood pressure values of patients at admission, 1 minute, 5 minutes, 10 minutes 15 minutes and 20 minutes will be recorded. After the procedure, HR values at the input, 1 minute, 5 minutes, 10 minutes, 15 minutes and 20 minutes will be recorded.

Study Arms (2)

high-flow nasal cannula group

Group 1

Procedure: high-flow nasal cannula / classic nasal cannula

classic nasal cannula group

Group 2

Procedure: high-flow nasal cannula / classic nasal cannula

Interventions

high-flow nasal cannula / classic nasal cannula PROCEDURE

The oxygen given with nasal cannula cannot be humidified, causing drying in mucous membranes at high flow rates of more than 4L/min and problems in patient compliance.This situation prevents us to increase the oxygen FiO2 rate applied to the patient above 40%.According to the nasal cannula high-flow nasal cannula where heated and humidified oxygen can be delivered, oxygen therapy can be applied at a flow rate of 25L/min.It provides high flows easily, prevents the airway epithelium from drying out and improves mucus cleansing, causing a decrease in anatomical dead space.It provides discharge of expired air in the upper airways.It increases alveolar ventilation.It offers a stream adjusted to all children.Flow and titration can be adjusted according to the child's weight and effect.

classic nasal cannula group; high-flow nasal cannula group

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children of 4-18 years of age, whose informed consent is signed by their parents.

You may qualify if:

• Children aged 4-18 years
• Patients undergoing gastroenterological intervention
• Patients undergoing sedation
• Patients with ASA 1-2 risk group
• Patients who have been informed of the study for informed consent

You may not qualify if:

• Patients under 4 years old and over 18 years old
• Patients with ASA 3 and above risk groups
• Patients who refuse to participate in the study

Sponsors & Collaborators

• Kocaeli Derince Education and Research Hospital: lead

Study Sites (1)

Sami Olcay OZBAY

Kocaeli, Turkey (Türkiye)

RECRUITING

Study Officials

• Mehmet YILMAZ

  Assistant Professor

  STUDY DIRECTOR

Central Study Contacts

Sami Olcay OZBAY

CONTACT

+905415274100; drsmolcy@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, RESİDENT

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: July 15, 2020
• Study Start: February 27, 2020
• Primary Completion: October 1, 2020
• Study Completion: February 1, 2021
• Last Updated: July 15, 2020

Record last verified: 2020-07

Locations

TU (1)