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临床试验/CTRI/2024/01/061058
CTRI/2024/01/061058已完成2/3 期

Effect of right and left lateral position combined with soft tissue manipulation on oxygen saturation and hemodynamic parameters in mechanically ventilated pediatric patients.

Nishant1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月8日最近更新:

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
• Oxygen saturation

研究概览

简要总结

This is a crossover study. Aim of the study is to see the impact

of the left and right lateral position combined with soft tissue manipulation on oxygen

saturation, SF ratio, heart rate, blood pressure and respiratory rate.

A total of 60 participants will be randomly allocated using a computer-generated

randomization list to receive either of the two intervention protocols. Each participant will

receive both interventions with a washout interval of 2 hours between each intervention.

PRE-intervention readings of various outcome measures including oxygen saturation, SF

ratio, heart rate, blood pressure and respiratory rate, of each participant will be taken

Suctioning will be done before positioning. A pillow will be placed between two legs and

the upper knee flexed. The upper limbs will be placed away from the body this prevents any

mechanical obstruction to the expansion of the lungs. The position of the endotracheal tube

will be checked and all other invasive lines will also be checked. The feeding via nasogastric

tube will be stopped 2 hours before position.

Soft tissue manipulation therapy will be performed for 5 minutes on the chest and 5 minutes

on the back. Soft tissue manipulation will consist of 4 steps, as follows: effleurage,

petrissage, kneading and stroking. Each step will be performed 10 times for 1 minute. Then

the patient will be laid in the position assigned to the group either left lateral or right lateral

for 1 hour.

Patients placed in either right lateral or left lateral position will be allowed to stabilize in the

first 15 minutes of the desired position and then after 15 minutes first reading of various

outcome measures will be collected and marked as (POST-1)

Further readings i.e. POST-2, POST-3 and POST-4 of Oxygen saturation, S/F ratio, heart

rate, respiratory rate and blood pressure will be measured every 15 minutes after the first 15

minutes of positioning.

After a washout interval of 2 hours soft tissue manipulation therapy is performed again as

done previously and the patient is laid in an alternate position for 1 hour.

During the intervention to ensure that the paediatric patient body temperature is not reduced,

the body temperature will be monitored every hour ICU monitor and the least painful

diagnostic or therapeutic procedure performed during the study. If the oxygen saturation in

any position will be less than 85%, the patient heart rate reaches about 200 beats per minute

or less than 100 beats per minute and/or the respiratory rate increases (more than 60 breaths

per minute), then the patient would be returned to the supine position and will be

immediately notified to the physician.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
1.00 Month(s) 至 59.00 Month(s)(—)
性别
All

入选标准

  • 1 Mechanically ventilated pediatric patients 2 Pediatric patients from the age group 0-59 months 3 Pediatric patients with respiratory failure 4 Pediatric patient with neurological disorders 5 Subjects with known pulmonary pathologies.

排除标准

  • 1 Fever 2 Hypertension or hypotension 3 Subjects with known cardiac disorders 4 Hemodynamic unstability.

结局指标

主要结局

• Oxygen saturation

时间窗: After 15 minutes, after 30 minutes, after 45 minutes and after 60 minutes of intervention

• SF ratio

时间窗: After 15 minutes, after 30 minutes, after 45 minutes and after 60 minutes of intervention

• Heart rate

时间窗: After 15 minutes, after 30 minutes, after 45 minutes and after 60 minutes of intervention

• Blood pressure

时间窗: After 15 minutes, after 30 minutes, after 45 minutes and after 60 minutes of intervention

• Respiratory rate

时间窗: After 15 minutes, after 30 minutes, after 45 minutes and after 60 minutes of intervention

次要结局

未报告次要终点

研究者

发起方
Nishant
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Nishant

College of Physiotherapy, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak

研究点 (1)

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