Effect of right and left lateral position combined with soft tissue manipulation on oxygen saturation and hemodynamic parameters in mechanically ventilated pediatric patients.
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
Nishant
College of Physiotherapy, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak
