Cerebral PalsyNCT05724030
Use of Integrated Pulmonary Index Monitorisation in Children Undergoing Botulinum Toxin Injection
A study testing integrated pulmonary index and saturation in people with Cerebral Palsy and Pediatric ALL, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to detect hypoxia early with ıntegrated pulmonary index monitoring compared to saturation. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Cerebral Palsy, Pediatric ALL
- What is being tested?
- integrated pulmonary index and saturation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Apr 2023to 11 Oct 2024
- Phase
- Interventional
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 4-16 age pediatrics
- undergoing botilinum injection with sedation
- asa 1-2
Who cannot join
- > 18 age
- asa 3-4
- patients with upper respiratory tract infection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli University School of Medicine
Kocaeli, 41900
About this study
Official title: Effect of Integrated Pulmonary Index on Hypoxia
This study aimed to detect hypoxia early with ıntegrated pulmonary index monitoring compared to saturation.
Read the detailed description
This trial will be held at the kocaeli Universty Hospital. 75 children 4-17 years of age undergoing botulinum toxin injection with sedation will be enrolled in this prospective study. Patients premedicated with midasolam iv 0.5 mg bolus and then sedated with propofol 1 mg/kg and fentanyl 0.5 mg/kg . Integrated pulmonary monitoring and noninvasive capnograhy will be used. Bis monitoring and spo2 monitoring will be applied. standard anesthesia monitoring including noninvasive blood pressure, spo2 , ekg and heart rate will be monitored. This trial aimed to detect hypoxia and apnea earlier than pulse oximetry.
- Conditions
- Cerebral Palsy, Pediatric ALL
- Being tested
- integrated pulmonary index, saturation
- Keywords
- botilinum toxin, pediatrics, ıntegrated pulmonary index, hypoxia
- Medical subject headings
- Cerebral Palsy, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
integrated pulmonary indexDevice
integarted pumobary index monitoring
saturationDevice
saturation monitorization
| Study group | Role | What they receive |
|---|---|---|
| integrated pulmonary index hypoxia -capnogarph | Active comparator | integrated pulmonary index montorization apliied Receives: Device: integrated pulmonary index; Device: saturation |
| saturation - apnea | Experimental | saturation apllied Receives: Device: integrated pulmonary index; Device: saturation |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypoxia
desaturation spo2 below 90
Measured: 20 seconds
Secondary outcomes (1)
apnea - ıntegrated pulmonary index
no respiration ıntegrated pulmonary index under 4
Measured: 20 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start3 Apr 2023
- Primary completion3 Sep 2024
- Study completion11 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Ipek ARSLAN, Turkish Society of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724030
- Sponsor's protocol ID
- KAEK/26.bl.06
- Status last verified
- Dec 2023
- First submitted
- 24 Jan 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Integrated Pulmonary Index on Hypoxia
- ClinicalTrials.gov ID
- NCT05724030
- Acronym / sponsor ID
- KAEK/26.bl.06
- Conditions
- Cerebral Palsy, Pediatric ALL
- Keywords
- botilinum toxin, pediatrics, ıntegrated pulmonary index, hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 3 Sep 2024 (actual)
- Study completion
- 11 Oct 2024 (actual)
- First posted
- 13 Feb 2023 (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.
This study aimed to detect hypoxia early with ıntegrated pulmonary index monitoring compared to saturation.
Detailed description
This trial will be held at the kocaeli Universty Hospital. 75 children 4-17 years of age undergoing botulinum toxin injection with sedation will be enrolled in this prospective study. Patients premedicated with midasolam iv 0.5 mg bolus and then sedated with propofol 1 mg/kg and fentanyl 0.5 mg/kg . Integrated pulmonary monitoring and noninvasive capnograhy will be used. Bis monitoring and spo2 monitoring will be applied. standard anesthesia monitoring including noninvasive blood pressure, spo2 , ekg and heart rate will be monitored. This trial aimed to detect hypoxia and apnea earlier than pulse oximetry.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| integrated pulmonary index hypoxia -capnogarph | Active comparator | Device: integrated pulmonary index, Device: saturationintegrated pulmonary index montorization apliied |
| saturation - apnea | Experimental | Device: integrated pulmonary index, Device: saturationsaturation apllied |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 4-16 age pediatrics
- undergoing botilinum injection with sedation
- asa 1-2
Key exclusion criteria (3 listed)
- > 18 age
- asa 3-4
- patients with upper respiratory tract infection
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 |
|---|---|---|
| integrated pulmonary indexintegarted pumobary index monitoring | Device | integrated pulmonary index hypoxia -capnogarph, saturation - apnea |
| saturationsaturation monitorization | Device | integrated pulmonary index hypoxia -capnogarph, saturation - apnea |
Primary outcome
hypoxia
Time frame: 20 seconds
desaturation spo2 below 90
1 secondary outcome
apnea - ıntegrated pulmonary index
Time frame: 20 seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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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.
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?
A study testing integrated pulmonary index and saturation in people with Cerebral Palsy and Pediatric ALL, run by Kocaeli University 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 3 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: finished, as of the sponsor's last update on 15 Oct 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
hypoxia (time frame: 20 seconds). 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 Oct 2024.