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Status unknownNCT04472273Updated Jul 15, 2020

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

An observational study in Sedation Complication, sponsored by Kocaeli Derince Education and Research Hospital. Status unknown at 1 site in Turkey. Open to participants aged 4 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-15.

Sponsored by Kocaeli Derince Education and Research Hospital · Observational

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
82
Ages
4 Years to 18 Years
Sex
All
01

Study 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.

Read the detailed description

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.

Classical nasal cannula oxygen therapy application; It is a system made of plastic or rubber material with two open ends placed in the patient's nostrils. It is the most commonly used oxygen therapy application method. However, it has some disadvantages. The most important of these is that the oxygen given in this method cannot be humidified, causing drying in mucous membranes at high flow rates of more than 4 L / 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 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.

02

Conditions studied

  • Sedation Complication

Keywords

  • high-flow oxygen therapy
  • pediatric outpatients
  • sedation
03

In context

Lead sponsor

Kocaeli Derince Education and Research Hospital is the lead sponsor of 28 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
82 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Procedurehigh-flow nasal cannula / classic nasal cannula

    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.

06

What researchers measure

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.

    Time frame: 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 (both systolic and diastolic blood pressure) are recorded as data in patients in high-flow nasal cannula and classical nasal cannula oxygen therapy applications.

    Time frame: 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.

07

Study locations

1 of 1 sites recruiting
  • Sami Olcay OZBAY
    Kocaeli, Turkey
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04472273
Lead sponsor
Kocaeli Derince Education and Research Hospital
Responsible party
Sami Olcay Özbay (MD, RESİDENT, Kocaeli Derince Education and Research Hospital) — Principal investigator
First posted
Jul 15, 2020
Start date
Feb 27, 2020
Primary completion
Oct 2020 (estimated)
Completion
Feb 2021 (estimated)
Last update
Jul 15, 2020

Study contacts

Sami Olcay OZBAY
Contact
drsmolcy@gmail.com
+905415274100
Mehmet YILMAZ
study director · Assistant Professor

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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