Sedation ComplicationNCT04472273
Comparison of High-Flow Nasal Cannula Oxygen Application and Classic Nasal Cannula Oxygen Application
An observational study of Sedation Complication, run by Kocaeli Derince Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedation Complication
- What is being tested?
- high-flow nasal cannula / classic nasal cannula
- Type of treatment
- Surgery or procedure
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Feb 2020to Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children of 4-18 years of age, whose informed consent is signed by their parents.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sami Olcay OZBAY
Kocaeli
Sami Olcay OZBAY, +905415274100, drsmolcy@gmail.com
About this study
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
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.
Read more
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.
- Conditions
- Sedation Complication
- Being tested
- high-flow nasal cannula / classic nasal cannula
- Keywords
- high-flow oxygen therapy, pediatric outpatients, sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-flow nasal cannula / classic nasal cannulaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| high-flow nasal cannula group | Group 1 Receives: Procedure: high-flow nasal cannula / classic nasal cannula | |
| classic nasal cannula group | Group 2 Receives: Procedure: high-flow nasal cannula / classic nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start27 Feb 2020
- Primary completionOct 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli Derince Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sami Olcay Özbay, Kocaeli Derince Education and Research Hospital
- Investigators
- Mehmet YILMAZ, Study director, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472273
- Sponsor's protocol ID
- U1111-1253-6757
- Status last verified
- Jul 2020
- First submitted
- 16 Jun 2020
- Last updated
- 15 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04472273
- Acronym / sponsor ID
- U1111-1253-6757
- Conditions
- Sedation Complication
- Keywords
- high-flow oxygen therapy, pediatric outpatients, sedation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Kocaeli Derince Education and Research HospitalUniversity, hospital or other
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 15 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high-flow nasal cannula group | – | Procedure: high-flow nasal cannula / classic nasal cannulaGroup 1 |
| classic nasal cannula group | – | Procedure: high-flow nasal cannula / classic nasal cannulaGroup 2 |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children of 4-18 years of age, whose informed consent is signed by their parents.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high-flow nasal cannula / classic nasal cannulaThe 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. | Procedure or surgery | classic nasal cannula group, high-flow nasal cannula group |
Primary outcome
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.
SpO2 and ETCO2 are recorded as data in patients in high-flow nasal cannula and classical nasal cannula oxygen therapy applications.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet YILMAZ study director
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sedation Complication, run by Kocaeli Derince Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sami Olcay OZBAY (+905415274100, drsmolcy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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. (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.