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Completed

NCT Number: NCT06580522

The Effect of the Position Given to the Child After Weaning from Noninvasive Mechanical Ventilation on Physiological Symptoms

The aim of this clinical trial was to investigate the effect of the position given to children after weaning from noninvasive mechanical ventilation on the physiological symptoms (heart rate, oxygen saturation, respiratory rate and blood pressure) of children aged six months to six years in the Pediatric Intensive Care Unit.

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Key information

Conditions

Prone Position Behavior Child Deception Social Behavior Supine Position

Age range

6 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Cerrahpasa Medical Faculty Hospital

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Between 6 months and 6 years of age
  • Being monitored for respiratory diseases
  • Weaning from noninvasive mechanical ventilation during the research process
  • Body temperature within the normal range (36 centigrade-37,5 centigrade)
  • Verbal and written consent to participate in the study given by their parents

Exclusion criteria

  • Congenital anomaly
  • Surgical intervention that prevents supine/prone positioning
  • Development of pneumothorax during research
  • Hypoxia during the research

Treatment and study plan

Prone Position Group

Other

After the children in the prone position group were weaned from noninvasive mechanical ventilation according and started to breathe spontaneously, they were prone positioned and monitored for 120 minutes (2 hours) every 20 minutes (0.min, 20.min, 40.min, 60.min, 80.min, 100.min, 120.min) with a head-monitor for peak heart rate, oxygen saturation, respiratory rate and blood pressure.

Supine Position Group

Other

After the children in the supine position group were weaned from noninvasive mechanical ventilation according and started to breathe spontaneously, they were supine positioned and monitored for 120 minutes (2 hours) every 20 minutes (0.min, 20.min, 40.min, 60.min, 80.min, 100.min, 120.min) with a head-monitor for peak heart rate, oxygen saturation, respiratory rate and blood pressure.

Primary outcomes

  1. Pulse changes in children after weaning from noninvasive mechanical ventilation

    Time frame: 120 minutes after weaning from noninvasive mechanical ventilation

    Changes in the pulse rate of children will be measured and recorded at 20 minute intervals for 120 minutes after the position given to the children after weaning from noninvasive mechanical ventilation. The changes in the pulse rate values of the children between the age groups in the study in terms of minutes/pulse rate and the difference values between them according to minutes will be examined.

Other outcomes

  1. Oxygen saturation changes in children after weaning from noninvasive mechanical ventilation

    Time frame: 120 minutes after weaning from noninvasive mechanical ventilation

    Changes in oxygen saturation values of children will be measured and recorded at 20 minute intervals for 120 minutes after the position given to children after weaning from noninvasive mechanical ventilation. The changes in % of oxygen saturation values of children between the age groups in the study and the difference values between them according to minutes will be analyzed.

  2. Respiratory rate changes in children after weaning from noninvasive mechanical ventilation

    Time frame: 120 minutes after weaning from noninvasive mechanical ventilation

    Changes in respiratory rate values of children will be measured and recorded at 20 minute intervals for 120 minutes after the position given to children after weaning from noninvasive mechanical ventilation. The changes in the respiratory rate values of the children between the age groups in the study in minutes/respiratory rate and the difference values between them according to minutes will be examined.

  3. Blood pressure changes in children after weaning from noninvasive mechanical ventilation

    Time frame: 120 minutes after weaning from noninvasive mechanical ventilation

    Changes in blood pressure values of children will be measured and recorded at 20 minute intervals for 120 minutes after the position given to children after weaning from noninvasive mechanical ventilation. The changes in the blood pressure values of the children in mm/Hg between the age groups in the study and the difference values between them according to minutes will be examined.

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Collaborators

  • Istanbul University - Cerrahpasa

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 30, 2024
Registry last updated
Aug 30, 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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