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.

Study Overview

• Status: Completed
• Conditions: Child; Prone Position; Supine Position

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen saturation changes in children 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.	120 minutes after weaning from noninvasive mechanical ventilation
Respiratory rate changes in children 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.	120 minutes after weaning from noninvasive mechanical ventilation
Blood pressure changes in children 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.	120 minutes after weaning from noninvasive mechanical ventilation

Collaborators and Investigators

• Sponsor: Acibadem University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): July 26, 2024
• Study Completion (Actual): July 26, 2024

Study Registration Dates

• First Submitted: August 2, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): August 30, 2024
• Last Update Submitted That Met QC Criteria: August 29, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2023/30

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
• product manufactured in and exported from the U.S.: No