Desaturation of BloodNCT04622436
Early Recognition of Hypoxia in Pediatric Patient Sedation
An observational study of Desaturation of Blood, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Early recognition of hypoxia through monitoring in sedation practices in pediatric patients Read more about this study
- Who is it for?
- Ages 0 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Desaturation of Blood
- How many people
- 4 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2020to 1 Apr 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 0 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Pediatric patients under ages 18
Who may be able to join
- Patients under 18 years of age who underwent magnetic resonance imaging with sedoanalgesia
Who cannot join
- Patients over the age of 18,
- Those who do not speak Turkish,
- Presence of deformities in the nose and forehead,
- Those with nail polish and henna on their nails
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yuksek Ihtisas Education and Research Hospital
Bursa, Yıldırım, 16310
About this study
Official title: Comparison of MicroStream Capnography and Pulseoxymeter in Sedation of Pediatric Patients Undergoing Magnetic Resonance Imaging
Early recognition of hypoxia through monitoring in sedation practices in pediatric patients
Read the detailed description
In pediatric Magnetic Resonance Imaging, sedation is applied to pediatric patients of all age groups from newborn to adolescence in order to prevent the anxiety and movement of the patients during the imaging. It was aimed to compare the capnograph and pulse oximeter used for early detection of hypoxia in patient follow-up and to monitor the depth of sedation with the sedation score in the recovery room.
- Conditions
- Desaturation of Blood
- Keywords
- Hypoxia, Desaturation, MicroStream Capnography, Pulseoxymeter
- Medical subject headings
- Hypoxia
What is being measured
The primary outcome is the main question the study is designed to answer.
Early recognition of hypoxia
The rapid recognition of hypoxia that may occur with the initiation of the procedure
Measured: during the procedure
the changes in partial oxygen saturation
The rapid recognition of changes in partial oxygen saturation
Measured: during the procedure
Secondary outcomes (2)
Sedation score
Monitoring ramsey sedation scale. The minimum value is 1 and the maximum value is 6. Higher score means more sedatized.
Measured: during the procedure
recovery time
length of stay in the recovery room
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start1 Oct 2020
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Desaturation of BloodStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Canan Yılmaz, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622436
- Sponsor's protocol ID
- 2011-KAEK-25 2020/09-03
- Status last verified
- Nov 2020
- First submitted
- 16 Oct 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- 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 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of MicroStream Capnography and Pulseoxymeter in Sedation of Pediatric Patients Undergoing Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT04622436
- Acronym / sponsor ID
- 2011-KAEK-25 2020/09-03
- Conditions
- Desaturation of Blood
- Keywords
- Hypoxia, Desaturation, MicroStream Capnography, Pulseoxymeter
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 10 Nov 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.
Early recognition of hypoxia through monitoring in sedation practices in pediatric patients
Detailed description
In pediatric Magnetic Resonance Imaging, sedation is applied to pediatric patients of all age groups from newborn to adolescence in order to prevent the anxiety and movement of the patients during the imaging. It was aimed to compare the capnograph and pulse oximeter used for early detection of hypoxia in patient follow-up and to monitor the depth of sedation with the sedation score in the recovery room.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients under ages 18
Key inclusion criteria (1 listed)
- Patients under 18 years of age who underwent magnetic resonance imaging with sedoanalgesia
Key exclusion criteria (4 listed)
- Patients over the age of 18,
- Those who do not speak Turkish,
- Presence of deformities in the nose and forehead,
- Those with nail polish and henna on their nails
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Early recognition of hypoxia
Time frame: during the procedure
The rapid recognition of hypoxia that may occur with the initiation of the procedure
the changes in partial oxygen saturation
Time frame: during the procedure
The rapid recognition of changes in partial oxygen saturation
2 secondary outcomes
Sedation score
Time frame: during the procedure
recovery time
Time frame: immediately after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Desaturation of Blood
RecruitingObservational study
Diaphragm Dysfunction and Ultrasound Perioperatively
Respiratory Insufficiency, Pneumonia
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Desaturation of Blood, run by Bursa Yuksek Ihtisas Training 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 1 inclusion and 4 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 10 Nov 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early recognition of hypoxia (time frame: during the procedure). The study lists 2 primary outcomes in all. 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 10 Nov 2020.