Extruded the effectıveness of Prone posıtıon ın ınfants evaluatıon

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.

Study Overview

• Status: Completed
• Conditions: Prone posıtıon
• Intervention / Treatment: Other: Prone positioning

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Beykoz
    • Istanbul, Beykoz, Turkey, 34815
      • Istanbul Meidpol University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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.	Other: Prone positioning; 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.
No Intervention: Control group; Babies in the control group did not receive any treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Life Findings Monitoring Form	Pulse values were monitored for 48 hours	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	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	Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial Blood Gas Monitoring Form	After positioning, potansiyel hidrojen in blood were evaluated.	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.	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.	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.	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.	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.	Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Values Monitoring Form	Hemoglobin were evaluated.	Ekstübasyondan hemen önce ve ekstübasyon sonrası 24. ve 48. saatlerde alındı
Blood Values Monitoring Form	Hematocrit were evaluated.	Taken immediately before extubation and at 24 and 48 hours after extubation
Blood Values Monitoring Form	Leukocyte were evaluated.	Taken immediately before extubation and at 24 and 48 hours after extubation
Blood Values Monitoring Form	Platelet were evaluated.	Taken immediately before extubation and at 24 and 48 hours after extubation
Blood Values Monitoring Form	Procalcitonin were evaluated.	Taken immediately before extubation and at 24 and 48 hours after extubation
Blood Values Monitoring Form	C-reaktif protein were evaluated.	Taken immediately before extubation and at 24 and 48 hours after extubation

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Investigators: Study Director: Aysel Kökcü Doğan, Istanbul Meidpol University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): July 25, 2022

Study Registration Dates

• First Submitted: April 20, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Newborn; Prone Position; Extubation; Congenital Heart Diseases
• Other Study ID Numbers: E-10840098-772.02-3150

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No