Extruded the effectıveness of Prone posıtıon ın ınfants evaluatıon

NCT06493058 | Completed

• 1 other identifier: E-10840098-772.02-3150
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Prone posıtıon

Keywords

Congenital Heart Diseases; Extubation; Newborn; Prone Position

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Arterial Blood Gas Monitoring Form

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

• Arterial Blood Gas Monitoring Form

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

• Arterial Blood Gas Monitoring Form

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

• Arterial Blood Gas Monitoring Form

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

• Arterial Blood Gas Monitoring Form

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

Other Outcomes (6)

• Blood Values Monitoring Form

  Ekstübasyondan hemen önce ve ekstübasyon sonrası 24. ve 48. saatlerde alındı

• Blood Values Monitoring Form

  Taken immediately before extubation and at 24 and 48 hours after extubation

• Blood Values Monitoring Form

  Taken immediately before extubation and at 24 and 48 hours after extubation

Study Arms (2)

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.

Other: Prone positioning

Control group

NO INTERVENTION

Babies in the control group did not receive any treatment.

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 1 Day - 1 Year
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Meidpol University Hospital

Istanbul, Beykoz, 34815, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Aysel Kökcü Doğan

  Istanbul Meidpol University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 20, 2024
• First Posted: July 9, 2024
• Study Start: July 1, 2021
• Primary Completion: March 30, 2022
• Study Completion: July 25, 2022
• Last Updated: July 9, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)