<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04472273</url>
  </required_header>
  <id_info>
    <org_study_id>U1111-1253-6757</org_study_id>
    <nct_id>NCT04472273</nct_id>
  </id_info>
  <brief_title>Comparison of High-Flow Nasal Cannula Oxygen Application and Classic Nasal Cannula Oxygen Application</brief_title>
  <official_title>Comparison of the Efficiency of High-Flow Nasal Cannula Oxygen Application and Classic Nasal Cannula Oxygen Application in Pediatric Patients With Sedation for Gastrointestinal System Endoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kocaeli Derince Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kocaeli Derince Education and Research Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recently, sedation practices have increased for diagnostic and interventional procedures for&#xD;
      children in non-operating rooms. On the other hand, the rate of respiratory complications&#xD;
      especially in non-operating room sedation applications is quite high. Oxygen therapy in&#xD;
      sedation applied to non-operating room endoscopy patients is mostly performed with classical&#xD;
      nasal cannula. However, recently, the use of High-flow nasal cannula oxygen therapy has been&#xD;
      increasing.&#xD;
&#xD;
      According to the classical nasal cannula oxygen therapy application where non-moistened&#xD;
      oxygen is applied in high-flow nasal cannula oxygen therapy applications where heated and&#xD;
      humidified oxygen can be delivered, oxygen therapy can be applied at a flow rate of 25L /&#xD;
      min. This method has many advantages. Some of those; makes it possible to provide high flows&#xD;
      easily, prevents the airway epithelium from drying out and improves mucus cleansing, causing&#xD;
      a decrease in anatomical dead space. It provides discharge of expired air in the upper&#xD;
      airways. It reduces the respiration of gas with high CO2 and decreased O2. It increases&#xD;
      alveolar ventilation. It is easy to use and increases patient comfort. It offers a stream&#xD;
      adjusted to all children. Flow and titration can be adjusted according to the child's weight&#xD;
      and effect. Physiological evidence in the pediatric population indicates that flows equal to&#xD;
      or higher than 2 L / kg / min produce clinically significant pharyngeal pressure, improve&#xD;
      breathing and accelerate the emptying of the respiratory muscles. Because of all these&#xD;
      features, high-flow nasal cannula oxygen therapy application is used safely in pediatric&#xD;
      patients.&#xD;
&#xD;
      In general, it is reported that in non-operating room anesthesia, sedation or anesthesia&#xD;
      applied in pediatric patients causes undesirable effects by 20%, most of them (5.5%) have&#xD;
      respiratory complications and bradycardia due to hypoxemia.&#xD;
&#xD;
      In this study, we aimed to compare the respiratory and hemodynamic results of high-flow nasal&#xD;
      cannula oxygen application, which is routinely used in sedation applications in the pediatric&#xD;
      endoscopy unit of our hospital, with the classical nasal cannula oxygen therapy application.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recently, sedation practices have increased for diagnostic and interventional procedures for&#xD;
      children in non-operating rooms. On the other hand, the rate of respiratory complications&#xD;
      especially in non-operating room sedation applications is quite high. Oxygen therapy in&#xD;
      sedation applied to non-operating room endoscopy patients is mostly performed with classical&#xD;
      nasal cannula. However, recently, the use of High-flow nasal cannula oxygen therapy has been&#xD;
      increasing.&#xD;
&#xD;
      Classical nasal cannula oxygen therapy application; It is a system made of plastic or rubber&#xD;
      material with two open ends placed in the patient's nostrils. It is the most commonly used&#xD;
      oxygen therapy application method. However, it has some disadvantages. The most important of&#xD;
      these is that the oxygen given in this method cannot be humidified, causing drying in mucous&#xD;
      membranes at high flow rates of more than 4 L / min and problems in patient compliance. This&#xD;
      situation prevents us to increase the oxygen FiO2 rate applied to the patient above 40%.&#xD;
&#xD;
      According to the classical nasal cannula oxygen therapy application where non-moistened&#xD;
      oxygen is applied in high-flow nasal cannula oxygen therapy applications where heated and&#xD;
      humidified oxygen can be delivered, oxygen therapy can be applied at a flow rate of 25L /&#xD;
      min. This method has many advantages. Some of those; makes it possible to provide high flows&#xD;
      easily, prevents the airway epithelium from drying out and improves mucus cleansing, causing&#xD;
      a decrease in anatomical dead space. It provides discharge of expired air in the upper&#xD;
      airways. It reduces the respiration of gas with high CO2 and decreased O2. It increases&#xD;
      alveolar ventilation. It is easy to use and increases patient comfort. It offers a stream&#xD;
      adjusted to all children. Flow and titration can be adjusted according to the child's weight&#xD;
      and effect. Physiological evidence in the pediatric population indicates that flows equal to&#xD;
      or higher than 2 L / kg / min produce clinically significant pharyngeal pressure, improve&#xD;
      breathing and accelerate the emptying of the respiratory muscles. Because of all these&#xD;
      features, high-flow nasal cannula oxygen therapy application is used safely in pediatric&#xD;
      patients.&#xD;
&#xD;
      In general, it is reported that in non-operating room anesthesia, sedation or anesthesia&#xD;
      applied in pediatric patients causes undesirable effects by 20%, most of them (5.5%) have&#xD;
      respiratory complications and bradycardia due to hypoxemia.&#xD;
&#xD;
      In this study, we aimed to compare the respiratory and hemodynamic results of high-flow nasal&#xD;
      cannula oxygen application, which is routinely used in sedation applications in the pediatric&#xD;
      endoscopy unit of our hospital, with the classical nasal cannula oxygen therapy application.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 27, 2020</start_date>
  <completion_date type="Anticipated">February 2021</completion_date>
  <primary_completion_date type="Anticipated">October 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>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.</measure>
    <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.</time_frame>
    <description>SpO2 and ETCO2 are recorded as data in patients in high-flow nasal cannula and classical nasal cannula oxygen therapy applications.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <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.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">82</enrollment>
  <condition>Sedation Complication</condition>
  <arm_group>
    <arm_group_label>high-flow nasal cannula group</arm_group_label>
    <description>Group 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>classic nasal cannula group</arm_group_label>
    <description>Group 2</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>high-flow nasal cannula / classic nasal cannula</intervention_name>
    <description>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.</description>
    <arm_group_label>classic nasal cannula group</arm_group_label>
    <arm_group_label>high-flow nasal cannula group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children of 4-18 years of age, whose informed consent is signed by their parents.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 4-18 years&#xD;
&#xD;
          -  Patients undergoing gastroenterological intervention&#xD;
&#xD;
          -  Patients undergoing sedation&#xD;
&#xD;
          -  Patients with ASA 1-2 risk group&#xD;
&#xD;
          -  Patients who have been informed of the study for informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 4 years old and over 18 years old&#xD;
&#xD;
          -  Patients with ASA 3 and above risk groups&#xD;
&#xD;
          -  Patients who refuse to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mehmet YILMAZ</last_name>
    <role>Study Director</role>
    <affiliation>Assistant Professor</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sami Olcay OZBAY</last_name>
    <phone>+905415274100</phone>
    <email>drsmolcy@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sami Olcay OZBAY</name>
      <address>
        <city>Kocaeli</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sami Olcay OZBAY</last_name>
      <phone>+905415274100</phone>
      <email>drsmolcy@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>July 11, 2020</last_update_submitted>
  <last_update_submitted_qc>July 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kocaeli Derince Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Sami Olcay Özbay</investigator_full_name>
    <investigator_title>MD, RESİDENT</investigator_title>
  </responsible_party>
  <keyword>high-flow oxygen therapy</keyword>
  <keyword>pediatric outpatients</keyword>
  <keyword>sedation</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04472273
org study id: U1111-1253-6757
nct id: NCT04472273
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Other
measure: 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.
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.
description: SpO2 and ETCO2 are recorded as data in patients in high-flow nasal cannula and classical nasal cannula oxygen therapy applications.
measure: 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.
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.
description: 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.
arm group label: high-flow nasal cannula group
description: Group 1
arm group label: classic nasal cannula group
description: Group 2
intervention type: Procedure
intervention name: high-flow nasal cannula / classic nasal cannula
description: 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.
arm group label: classic nasal cannula group
arm group label: high-flow nasal cannula group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 4 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mehmet YILMAZ
role: Study Director
affiliation: Assistant Professor
last name: Sami Olcay OZBAY
phone: +905415274100
email: drsmolcy@gmail.com
facility: 
status: Recruiting
contact: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kocaeli Derince Education and Research Hospital
investigator full name: Sami Olcay Özbay
investigator title: MD, RESİDENT
sharing ipd: Undecided