Clinical trial NCT06493058: Extruded the effectıveness of Prone posıtıon ın ınfants evaluatıon
Official title: Evaluatıon of the Effectiveness of the Prone Position in Babies Extubed After Congenital Cardio Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prone posıtıon
Keywords: Congenital Heart Diseases
Extubation
Newborn
Prone Position
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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".

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Life Findings Monitoring Form
timeFrame: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation
measure: Life Findings Monitoring Form
timeFrame: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation
measure: Life Findings Monitoring Form
timeFrame: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation
Secondary outcomes:
measure: Arterial Blood Gas Monitoring Form
timeFrame: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation
measure: Arterial Blood Gas Monitoring Form
timeFrame: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation
measure: Arterial Blood Gas Monitoring Form
timeFrame: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation
measure: Arterial Blood Gas Monitoring Form
timeFrame: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation
measure: Arterial Blood Gas Monitoring Form
timeFrame: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation
measure: Arterial Blood Gas Monitoring Form
timeFrame: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation
Other outcomes:
measure: Blood Values Monitoring Form
timeFrame: Ekstübasyondan hemen önce ve ekstübasyon sonrası 24. ve 48. saatlerde alındı
measure: Blood Values Monitoring Form
timeFrame: Taken immediately before extubation and at 24 and 48 hours after extubation
measure: Blood Values Monitoring Form
timeFrame: Taken immediately before extubation and at 24 and 48 hours after extubation
measure: Blood Values Monitoring Form
timeFrame: Taken immediately before extubation and at 24 and 48 hours after extubation
measure: Blood Values Monitoring Form
timeFrame: Taken immediately before extubation and at 24 and 48 hours after extubation
measure: Blood Values Monitoring Form
timeFrame: Taken immediately before extubation and at 24 and 48 hours after extubation
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Meidpol University Hospital
state: Beykoz
Study officials:
affiliation: Istanbul Meidpol University
name: Aysel Kökcü Doğan
role: STUDY_DIRECTOR
References: