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临床试验/CTRI/2026/03/106459
CTRI/2026/03/106459尚未招募Phase 3 4

Effect Of Inspiratory Muscle Training and Early Mobilization to Improve Oxygenation and Pulmonary Functions in Patients with Pediatric Cardiac Surgery: A Pilot Randomized Controlled Trial

MGM Institute of Physiotherapy1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年3月28日最近更新:
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试验速览

阶段
Phase 3 4
状态
尚未招募
入组人数
30
试验地点
1
主要终点
1. Oxygenation

研究概览

简要总结

Male or female participants age 4-14 years are included in the study based on specific eligibility criteria. Informed written and verbal consent will be obtained from the parents of the participants before data collection. Demographic information including name age gender relevant medical and surgical history will be documented. All outcome variables will be measured on the first day before intervention, and on 6th day of surgery participants will be randomly allocated into 2 groups using block randomization: the interventional group will receive inspiratory muscle training with early mobilisation , while the control group will receive usual physiotherapeutic care. The outcome measure will include Oxygenation, Pulmonary functions, ABG Analysis, Heart rate, respiratory rate, Pain and the final conclusion will be drawn based on the comparative effectiveness of the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
4.00 Year(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • Both Male and female
  • Age 4-14 years
  • Both Invasive and Non-Invasive cardiac surgery procedures.

排除标准

  • Unstable patients
  • Patients with any neurological defect (eg- spina bifida,cerebral palsy)
  • Patients on mechanical ventilation support.

结局指标

主要结局

1. Oxygenation

时间窗: At baseline and on the 6th day of the surgery

2. Pulmonary Functions-Pimax

时间窗: At baseline and on the 6th day of the surgery

3. ABG Analysis-pH.PCO2

时间窗: At baseline and on the 6th day of the surgery

次要结局

  • 1. Heart Rate(2. respiratory Rate)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Sanika Girish Khawase

MGM Institute of Physiotherapy

研究点 (1)

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