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

NCT06580522 | Completed

• 1 other identifier: 2023/30
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prone Position; Supine Position; Child

Outcome Measures

Primary Outcomes (1)

• Pulse changes in children 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.

  120 minutes after weaning from noninvasive mechanical ventilation

Other Outcomes (3)

• Oxygen saturation changes in children after weaning from noninvasive mechanical ventilation

  120 minutes after weaning from noninvasive mechanical ventilation

• Respiratory rate changes in children after weaning from noninvasive mechanical ventilation

  120 minutes after weaning from noninvasive mechanical ventilation

• Blood pressure changes in children after weaning from noninvasive mechanical ventilation

  120 minutes after weaning from noninvasive mechanical ventilation

Study Arms (2)

Prone Position Group

EXPERIMENTAL

Children in this group were given the prone position after weaning from noninvasive mechanical ventilation and its effect on the physiologic symptoms of the children was examined.

Other: Prone Position Group

Supine Position Group

EXPERIMENTAL

Supine position group children were given supine position after weaning from noninvasive mechanical ventilation and the effects on physiologic symptoms were examined.

Other: Supine Position Group

Interventions

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.

Prone Position Group

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.

Supine Position Group

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Acibadem University: lead
• Istanbul University - Cerrahpasa: collaborator

Study Sites (1)

Istanbul University Cerrahpasa Medical Faculty Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Deception

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Duygu Gözen, Prof.Dr.

  Koç Üniversitesi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 30, 2024
• Study Start: March 1, 2023
• Primary Completion: July 26, 2024
• Study Completion: July 26, 2024
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)