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Clinical Trials/NCT06493058
NCT06493058
Completed
Not Applicable

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

Istanbul Medipol University Hospital1 site in 1 country40 target enrollmentJuly 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prone posıtıon
Sponsor
Istanbul Medipol University Hospital
Enrollment
40
Locations
1
Primary Endpoint
Life Findings Monitoring Form
Status
Completed
Last Updated
last year

Overview

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".

Registry
clinicaltrials.gov
Start Date
July 1, 2021
End Date
July 25, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istanbul Medipol University Hospital
Responsible Party
Principal Investigator
Principal Investigator

aysel kokcudogan

Assistant Professor

Istanbul Medipol University Hospital

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.

Outcomes

Primary Outcomes

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

  • Arterial Blood Gas Monitoring Form(Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation)

Study Sites (1)

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