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临床试验/CTRI/2024/08/073014
CTRI/2024/08/073014尚未招募不适用

EFFECTIVENESS OF SWALLOWING MANEUVER ON FUNCTIONAL ORAL INTAKE AND SALIVATION IN POST-EXTUBATED PATIENTS: A RANDOMIZED CONTROLLED TRIAL

Priya1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年9月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Functional oral intake and

研究概览

简要总结

Dysphagia is frequently observed in patients in the intensive care unit (ICU), but it often goes unnoticed and untreated, even though it’s linked to serious complications, extended ICU admissions, and longer hospital stays. Prolonged intubation (>48 hrs) can result in swallowing difficulties after extubation, impacting a person’s ability to eat properly and communicate. This study will determine the effect of swallowing maneuver on functional oral intake and amount of salivation in post-extubated patients in comparison to intervention and control group. Participants fulfilling the inclusion criteria in the ICUs of selected tertiary care teaching hospital will be recruited and randomised for the study. The functional oral intake will be determined by functional oral intake scale and amount of salivation will be determined by oral schirmer test(With participants sitting upright, a standardized 5mm-wide by 35 mm long Schirmer’s tear test strip will be placed at the floor of their mouth. At the end of 5min, a wetting length in millimetres will be recorded). Data analysis will be done by descriptive and inferential statistics. It will be done as per “Per-Protocol” analysis.

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
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients who are willing to participate.
  • Patients who have undergone intubation for ≥48hrs.
  • Patient of age ≥18 yrs.
  • Patient who will be able to follow verbal commands.
  • Patients who can understand Hindi or English fluently.

排除标准

  • Patient on atropine medication,cervical spinal injury, tracheostomized, history of neuromuscular disease, pathological swallowing difficulty before intubation, active respiratory infection, non- invasive mechanical ventilation post extubation.

结局指标

主要结局

Functional oral intake and

时间窗: Functional oral intake on 1st 2nd, 3rd, 4th and 5th day. | Amount of salivation on 1st ,3rd and 5th day.

Amount of salivation

时间窗: Functional oral intake on 1st 2nd, 3rd, 4th and 5th day. | Amount of salivation on 1st ,3rd and 5th day.

次要结局

  • N/A(N/A)

研究者

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

Priya

All India Institute of Medical Sciences, Jodhpur, Rajasthan

研究点 (1)

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