A Comparative Study To Find Out The Efficacy Of Oral Care With Chlorhedinine Versus Multicomponent Bundle Without Chlorhexidine In Mechanical Ventilated Patients In Intensive Care Unit
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,286
- 试验地点
- 1
- 主要终点
- Incidence of IVACs between control and intervention groups during ventilator days.
研究概览
简要总结
* Allthe patients above 18yrs admitting to six ICUs will be screened for our study,
* Submittedto intubation, expected to remain on mechanical ventilation for more than 48hrs.
* ICUprotocol for oral care without chlorhexidine will be standardized (TABLE 2)
* Afterenrollment, the intervention group will be given oral care with multicomponentcare bundle includes 0.20% chlorhexidine solution every 12 hrly and toothbrushing, oral suctioning and mouth/lip moisturization (TABLE 1) versus
* Thecontrol group will be given toothbrushing, oral suctioning and mouth/lipmoisturization without chlorhexidine care.
* Demographiccharacteristics including age, sex will be noted on admission.
* Theparticipants also will undergo the standard protocol for prevention of VAP,which included
* 1.Maintaining a semirecumbent body position, with head elevation of ≥ 30°,
* 2.Gastrointestinal bleeding prophylaxis,
* 3.Deep venous thrombosis prophylaxis and
* 4.Daily interruption of sedation with assessing the possibility of extubation
PRIMAZRY OBJECTIVE- Toevaluate the time to IVACs between control and intervention groups.
SECONDARY OBJECTIVE-
* To evaluate 1.oral health status dysfunctionmeasured using BOAS Beck oral assessment score
* 2.CPOT Critical care painobservation,
* 3. ventilator days,
* 4. ICU stay,
* 5. 28 day mortality,
* 6. VAP incidence
* Continueduntil the patient isextubated or tracheotomised or died
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Admitted to the ICU and requiring mechanical ventilation.
- •2.Anticipated to require mechanical ventilation for more than 48 hours.
- •3.Patient or legal representative has provided informed consent.
排除标准
- •ï€ªPatients with known hypersensitivity or allergy to Chlorhexidine.
- •ï€ªPatients already in another oral care study.
- •ï€ªPatients with severe oral trauma or recent oral surgery.
- •ï€ªPatients with a life expectancy of less than 48hrs Patients for whom oral care maybe contraindicated due to specific medical conditions.
- •(e.g. certain types of oral cancer, certain neurological conditions affecting swallowing).
结局指标
主要结局
Incidence of IVACs between control and intervention groups during ventilator days.
时间窗: 6 weeks of ICU stay
次要结局
- To evaluate 1.oral health status dysfunction measured using BOAS Beck oral assessment score(2.CPOT Critical care pain observation,)