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Completed

NCT Number: NCT06493058

Extruded the effectıveness of Prone posıtıon ın ınfants evaluatıon

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.

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Key information

Conditions

Prone posıtıon Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

1 day–1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Meidpol University Hospital

Istanbul, Beykoz, 34815, Turkey (Türkiye)

About this study

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".

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prone Positioning

Other

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Arterial Blood Gas Monitoring Form

    Time frame: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation

    After positioning, potansiyel hidrojen in blood were evaluated.

  2. Arterial Blood Gas Monitoring Form

    Time frame: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation

    After positioning, Partial arterial oxygen pressure, were evaluated.

  3. Arterial Blood Gas Monitoring Form

    Time frame: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation

    After positioning, Partial arterial carbon dioxide pressure were evaluated.

  4. Arterial Blood Gas Monitoring Form

    Time frame: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation

    After positioning, Arterial oxygen saturation were evaluated.

  5. Arterial Blood Gas Monitoring Form

    Time frame: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation

    After positioning, Laktat, were evaluated.

  6. Arterial Blood Gas Monitoring Form

    Time frame: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation

    After positioning, arterial blood gases were evaluated.

Other outcomes

  1. Blood Values Monitoring Form

    Time frame: Ekstübasyondan hemen önce ve ekstübasyon sonrası 24. ve 48. saatlerde alındı

    Hemoglobin were evaluated.

  2. Blood Values Monitoring Form

    Time frame: Taken immediately before extubation and at 24 and 48 hours after extubation

    Hematocrit were evaluated.

  3. Blood Values Monitoring Form

    Time frame: Taken immediately before extubation and at 24 and 48 hours after extubation

    Leukocyte were evaluated.

  4. Blood Values Monitoring Form

    Time frame: Taken immediately before extubation and at 24 and 48 hours after extubation

    Platelet were evaluated.

  5. Blood Values Monitoring Form

    Time frame: Taken immediately before extubation and at 24 and 48 hours after extubation

    Procalcitonin were evaluated.

  6. Blood Values Monitoring Form

    Time frame: Taken immediately before extubation and at 24 and 48 hours after extubation

    C-reaktif protein were evaluated.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

Evaluatıon of the Effectiveness of the Prone Position in Babies Extubed After Congenital Cardio Surgery

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 9, 2024
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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