Prone posıtıonNCT06493058
Extruded the effectıveness of Prone posıtıon ın ınfants evaluatıon
A study testing Prone positioning in people with Prone posıtıon, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the effect of prone position on vital signs, arterial blood gases and blood values in 0-1 year old infants extubated after congenital heart surgery. The study was a randomised controlled experimental type study. Read more about this study
- Who is it for?
- Ages 1 day to 1 yearHealthy volunteers can take part
- Conditions the study is for
- Prone posıtıon
- What is being tested?
- Prone positioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 25 Jul 2022
- 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 1 day to 1 year
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- To be between 0-1 years old
- Having congenital heart surgery
- Endotracheal intubation has been applied
- Being extubated after congenital heart surgery
- Obtaining permission from their parents to participate in the study
Who cannot join
- In addition to the diagnosis of congenital heart disease, congenital heart disease of the lungs with any of the anomalies,
- Position that may affect cardiac, circulatory and respiratory functions or surgical intervention that prevents ECMO (open sternum bone, ECMO support, etc.)
- Complications developed during the study,
- Infants whose parents did not agree to participate in the study were included in the study. is not recognised.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Meidpol University Hospital
Istanbul, Beykoz, 34815
About this study
Official title: Evaluatıon of the Effectiveness of the Prone Position in Babies Extubed After Congenital Cardio Surgery
The aim of this study was to determine the effect of prone position on vital signs, arterial blood gases and blood values in 0-1 year old infants extubated after congenital heart surgery. The study was a randomised controlled experimental type study.
Read the detailed description
The sample of the study consisted of 40 infants aged 0-1 year who underwent surgery in the Cardiovascular Surgery Intensive Care Unit of a private hospital.Data collection tools consisted of "Data Collection Form", "Vital Signs Follow-up Form", "Arterial Blood Gas Follow-up Form", "Blood Values Follow-up Form" prepared by the researcher in line with the literature information and some measurement data used in the study (arterial blood sample obtained with the blood gas measurement device used in the NICU and blood gas parameters (PaCO2, pH, PaO2, Lac and SaO2) and bedside monitor).
The study was conducted in the Cardiovascular Surgery Intensive Care Unit of a private foundation university hospital. Infants between the ages of 0 and 1 year who had undergone congenital heart surgery and were extubated after surgery, who did not have any congenital anomalies of the lungs in addition to congenital heart disease, who did not have any condition that could affect cardiac, circulatory and respiratory functions or prevent positioning were included in the study. The infants to be included in the study were randomly selected to the control and study groups to avoid bias in the study. Which of the experimental or control groups the infants included in the study would be in was determined by using the address "https://www.calculatorsoup.com".
- Conditions
- Prone posıtıon
- Being tested
- Prone positioning
- Keywords
- Congenital Heart Diseases, Extubation, Newborn, Prone Position
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone positioningOther
The babies in the study group were given the supine, right lateral and left lateral positions (12×1), which are used in nursing care practices in the clinic after extubation, in addition to the supine, right lateral and left lateral positions (12×1), the prone position was given twice a day for 2×2 hours twice a day within 48 hours after extubation, with the head on the midline of the neck and the head facing to the right or left side.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | In our study, the babies in the study group were given the supine, right lateral and left lateral positions (12×1), which are used in nursing care practices in the clinic after extubation, in addition to the supine, right lateral and left lateral positions (12×1), the prone position was given twice a day for 2×2 hours twice a day within 48 hours after extubation, with the head on the midline of the neck and the head facing to the right or left side. Receives: Other: Prone positioning |
| Control group | No intervention | Babies in the control group did not receive any treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life Findings Monitoring Form
Pulse values were monitored for 48 hours
Measured: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation
Life Findings Monitoring Form
Saturation values were monitored for 48 hours
Measured: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation
Life Findings Monitoring Form
Blood pressure values were monitored for 48 hours
Measured: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation
Secondary outcomes (6)
Arterial Blood Gas Monitoring Form
After positioning, potansiyel hidrojen in blood were evaluated.
Measured: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation
Arterial Blood Gas Monitoring Form
After positioning, Partial arterial oxygen pressure, were evaluated.
Measured: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation
Arterial Blood Gas Monitoring Form
After positioning, Partial arterial carbon dioxide pressure were evaluated.
Measured: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation
Arterial Blood Gas Monitoring Form
After positioning, Arterial oxygen saturation were evaluated.
Measured: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation
Arterial Blood Gas Monitoring Form
After positioning, Laktat, were evaluated.
Measured: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation
Arterial Blood Gas Monitoring Form
After positioning, arterial blood gases were evaluated.
Measured: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Jul 2021
- Primary completion30 Mar 2022
- Study completion25 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prone posıtıonStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aysel kokcudogan, Istanbul Medipol University Hospital
- Investigators
- Aysel Kökcü Doğan, Study director, Istanbul Meidpol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493058
- Sponsor's protocol ID
- E-10840098-772.02-3150
- Status last verified
- Jun 2024
- First submitted
- 20 Apr 2024
- Last updated
- 9 Jul 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 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluatıon of the Effectiveness of the Prone Position in Babies Extubed After Congenital Cardio Surgery
- ClinicalTrials.gov ID
- NCT06493058
- Acronym / sponsor ID
- E-10840098-772.02-3150
- Conditions
- Prone posıtıon
- Keywords
- Congenital Heart Diseases, Extubation, Newborn, Prone Position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 25 Jul 2022 (actual)
- First posted
- 9 Jul 2024 (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.
The aim of this study was to determine the effect of prone position on vital signs, arterial blood gases and blood values in 0-1 year old infants extubated after congenital heart surgery. The study was a randomised controlled experimental type study.
Detailed description
The sample of the study consisted of 40 infants aged 0-1 year who underwent surgery in the Cardiovascular Surgery Intensive Care Unit of a private hospital.Data collection tools consisted of "Data Collection Form", "Vital Signs Follow-up Form", "Arterial Blood Gas Follow-up Form", "Blood Values Follow-up Form" prepared by the researcher in line with the literature information and some measurement data used in the study (arterial blood sample obtained with the blood gas measurement device used in the NICU and blood gas parameters (PaCO2, pH, PaO2, Lac and SaO2) and bedside monitor).
The study was conducted in the Cardiovascular Surgery Intensive Care Unit of a private foundation university hospital. Infants between the ages of 0 and 1 year who had undergone congenital heart surgery and were extubated after surgery, who did not have any congenital anomalies of the lungs in addition to congenital heart disease, who did not have any condition that could affect cardiac, circulatory and respiratory functions or prevent positioning were included in the study. The infants to be included in the study were randomly selected to the control and study groups to avoid bias in the study. Which of the experimental or control groups the infants included in the study would be in was determined by using the address "https://www.calculatorsoup.com".
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Prone positioningIn our study, the babies in the study group were given the supine, right lateral and left lateral positions (12×1), which are used in nursing care practices in the clinic after extubation, in addition to the supine, right lateral and left lateral positions (12×1), the prone position was given twice a day for 2×2 hours twice a day within 48 hours after extubation, with the head on the midline of the neck and the head facing to the right or left side. |
| Control group | No intervention | –Babies in the control group did not receive any treatment. |
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- To be between 0-1 years old
- Having congenital heart surgery
- Endotracheal intubation has been applied
- Being extubated after congenital heart surgery
- Obtaining permission from their parents to participate in the study
Key exclusion criteria (4 listed)
- In addition to the diagnosis of congenital heart disease, congenital heart disease of the lungs with any of the anomalies,
- Position that may affect cardiac, circulatory and respiratory functions or surgical intervention that prevents ECMO (open sternum bone, ECMO support, etc.)
- Complications developed during the study,
- Infants whose parents did not agree to participate in the study were included in the study. is not recognised.
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 |
|---|---|---|
| Prone positioningThe babies in the study group were given the supine, right lateral and left lateral positions (12×1), which are used in nursing care practices in the clinic after extubation, in addition to the supine, right lateral and left lateral positions (12×1), the prone position was given twice a day for 2×2 hours twice a day within 48 hours after extubation, with the head on the midline of the neck and the head facing to the right or left side. | Other | Intervention group |
Primary outcome
Life Findings Monitoring Form
Time frame: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation
Pulse values were monitored for 48 hours
Life Findings Monitoring Form
Time frame: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation
Saturation values were monitored for 48 hours
Life Findings Monitoring Form
Time frame: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation
Blood pressure values were monitored for 48 hours
6 secondary outcomes
Arterial Blood Gas Monitoring Form
Time frame: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation
Arterial Blood Gas Monitoring Form
Time frame: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation
Arterial Blood Gas Monitoring Form
Time frame: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation
Arterial Blood Gas Monitoring Form
Time frame: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation
Arterial Blood Gas Monitoring Form
Time frame: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation
Arterial Blood Gas Monitoring Form
Time frame: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation
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 9 Jul 2024.
- Individual participant dataSharing planned: No
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.
Aysel Kökcü Doğan study director
Istanbul Meidpol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prone positioning in people with Prone posıtıon, run by Istanbul Medipol University 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 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: finished, as of the sponsor's last update on 9 Jul 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?
Life Findings Monitoring Form (time frame: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation). The study lists 3 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 9 Jul 2024.