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临床试验/CTRI/2025/12/099945
CTRI/2025/12/099945尚未招募不适用

To Compare Pressure Support Adjustments Using Diaphragmatic Thickness Fraction And Conventional Method In Patients With Respiratory Distress On Mechanical Ventilation Admitted In ICU: A Randomized Controlled Trial.

Uttar Pradesh University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2026年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
78
试验地点
1

研究概览

简要总结

TitleTo Compare Pressure Support Adjustments Using Diaphragmatic Thickness Fraction and Conventional Methods in Patients with Respiratory Distress on Mechanical Ventilation Admitted in ICU A Randomized Controlled TrialIntroductionRespiratory distress requiring mechanical ventilation is common in ICUs. Proper adjustment of pressure support is vital to prevent diaphragmatic atrophy from over assistance and muscle fatigue or ventilator asynchrony from under assistance. Conventional adjustments use parameters like tidal volume and respiratory rate which may not accurately reflect diaphragm function. Diaphragmatic Thickness Fraction DTF measured by ultrasound can indicate diaphragm activity and may help in more precise adjustments. This study will compare DTF guided and conventional RSBI guided methods for pressure support adjustment to improve patient outcomes.Review of Literature Barati et al 2021 compared RSBI guided and tidal volume with respiratory rate guided pressure support adjustment in ICU patients with respiratory distress. RSBI guidance provided faster symptom improvement though final outcomes were similar. Evidence on using diaphragmatic ultrasound for guiding ventilation is limited.

Aim To compare pressure support adjustments using DTF and conventional methods in mechanically ventilated ICU patients with respiratory distress.

Objectives Primary To compare DTF guided and RSBI guided pressure support adjustments Secondary To compare patient ventilator synchrony time to relief of distress hemodynamic parameters and feasibility of using DTF in routine ICU practice

Justification Pressure support in ventilated patients is often adjusted empirically. DTF offers a direct noninvasive assessment of diaphragm function which may allow more individualized and accurate ventilator settings improving comfort and recovery.

Methodology A prospective randomized controlled trial will be conducted in ICU after ethics approval and CTRI registration. Adult patients aged 18 to 60 years with respiratory distress requiring mechanical ventilation and RDOS score above 3 will be included. Patients with neuromuscular disease diaphragmatic paralysis or hemodynamic instability will be excluded. Participants will be randomized into two groups using sealed envelope method.

Group A Conventional RSBI guided Pressure Support Adjustment RSBI will be measured every 15 minutes for 2 hours and pressure support adjusted to maintain RSBI at or below 105.

Group B DTF guided Pressure Support Adjustment Diaphragm thickness will be measured using ultrasound at end expiration and end inspiration. DTF will be calculated and measured every 15 minutes for 2 hours. Pressure support will be adjusted to maintain DTF at or above 30 percent.

Outcome Variables Independent variable method of pressure support adjustment Dependent variables DTF RSBI ventilator synchrony time to relief of distress and hemodynamic parameters

Expected Outcome DTF guided adjustment is expected to improve patient ventilator synchrony provide faster relief of respiratory distress and offer a more physiologic and feasible approach to individualized ventilator management in ICU patients.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Adult patients (18-60 years) on pressure support mechanical ventilation in ICU.
  • Respiratory distress using RDOS (Respiratory Distress Observational scale) more than 3 (corresponding with DTF less than 30 and RSBI more than 105 as per previous studies).
  • Post operative & Trauma patients needing elective ventilation.

排除标准

  • Patients with acute or chronic lung pathology.
  • Patients having neuromuscular disorder.
  • Cardiac arrest or hemodynamic instability.
  • Transfer to another ward or hospital during study.
  • Withdrawal of consent or inability to complete study protocol.

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Prashant Kumar Mishra

Uttar Pradesh university of medical sciences

研究点 (1)

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