A Prospective observational study on the treatment and outcome of different poisoning cases in a tertiary care teaching hospital of Northern India.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- PRIMARY OBJECTIVES:
研究概览
简要总结
The present prospective observational study shall be conducted by the Postgraduate department of Pharmacology and Therapeutics in collaboration with the department of Medicine, Government Medical College, Jammu for a period of one year. The study shall be initiated after obtaining necessary approval from Institutional Ethics Committee, Government Medical College, Jammu. A written informed consent shall be obtained from all the patients / legally authorized representatives(in case patient will not be able to consent) after explaining the nature and purpose of the study in a vernacular language. The patients of poisoning reporting to the Emergency in the department of Medicine, Government Medical College, Jammu shall be enrolled in the study only after fulfilling following Inclusion and Exclusion criteria:-
INCLUSION CRITERIA:-
-All suspected cases of poisoning of age 18 years or more of both sexes.
-All suspected cases of poisoning including drug overdose and snake bite.
EXCLUSION CRITERIA:-
-Patients with age less than 18 years.
-Patients who died before clinical evaluation.
-Patients who left against medical advice.
-Patients/ legally authorized representatives not willing to give consent.
All principles and bioethics shall be followed as per Good Clinical Practices prescribed by Academic Clinical Trials and confidentiality shall be maintained in all records. The data collected from the case files of the study patients shall be noted down and tabulated on a structured proforma specially designed for this purpose which shall further be interpreted and evaluated using appropriate Statistical Analysis.
STUDY POPULATION:-
All the patients of poisoning due to toxic chemicals, drug overdose and snake bite reporting to Emergency in the department of Medicine of Government Medical College, Jammu either directly or after referral from peripheral medical facilities fulfilling the inclusion and exclusion criteria shall be the study participants and they shall be followed till discharge or death.
PARAMETERS FOR DATA COLLECTION:-
The data shall be collected from the case files of the study patients which shall include the following parameters:-
1-Data regarding sociodemographic variables of all study patients including age ,sex ,education marital status, geographical region etc.
2-A detailed history about nature of poison, its class, trade and chemical name, route of ingestion and quantity consumed, place of incident, intention and mode of poisoning , circumstantial evidence in form of bottle, container or empty strip of medicines brought by attendants, presenting complaints, first aid/treatment received at primary level, time lag from exposure of poisoning substance to first aid and time lag from first aid to arrival in our hospital, mode of transportation to hospital. Data regarding medicolegal formalities as per institution’s protocols.
3-A detailed general physical examination of the patient including smell of poisoning substance ,temperature, pulse, BP, type of breathing, tachypnoea, dyspnea, pallor, icterus , cyanosis, pupil size, any fasciculations, condition of skin dry/sweating, salivation etc, burns on lips or buccal mucosa. Jugular venous pressure, oxygen saturation, oedema feet etc.
4-Systemic examination of cardiovascular, respiratory and nervous systems.
5-Mental/emotional state of study patient and any comorbid condition if any .
6-Routine investigations including CBC, TLC, DLC, PBF, BT, CT, LFT, RFT, urine routine examination, random blood sugar, X-ray chest, CT and MRI if indicated, Special investigations like ABG,if indicated.
7-Treatment of poisoning patients and therapeutic intervention as per standard protocols including gastric lavage, administration of specific antidotes, antivenom serum etc.
8-Complications or any disability resulting from poisoning or snakebite and their management.
9-Patients undergoing hemodialysis/peritoneal dialysis, ventilatory support and temporary pacing.
10- In hospital outcome that is discharged or died.
11- Total duration of hospital and ICU stay.
STATISTICAL ANALYSIS:
Statistical Analysis of the data will be done using Microsoft Excel software and SPSS version 23.0. Categorical variables will be presented as frequency (n) and percentages(%) and quantitative variables as mean + SD. End point of the study of patients of poisoning will be clinical recovery, disability or death of the patient enrolled in the study.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •INCLUSION CRITERIA:- -All suspected cases of poisoning of age 18 years or more of both sexes.
- •All suspected cases of poisoning including drug overdose and snake bite.
排除标准
- •EXCLUSION CRITERIA:-.
- •Patients with age less than 18 years.
- •Patients who died before clinical evaluation.
- •Patients who left against medical advice.
- •Patients/ legally authorized representatives not willing to give consent.
结局指标
主要结局
PRIMARY OBJECTIVES:
时间窗: At the day of admission and discharge
1. To know socio-demographic related characteristics in poisoning cases.
时间窗: At the day of admission and discharge
2. To know the pattern of different poisoning including incidence, nature, severity, cause/reason of poisoning.
时间窗: At the day of admission and discharge
3. To know the pharmacological management including antidotes given in various poisoning cases.
时间窗: At the day of admission and discharge
次要结局
- SECONDARY OBJECTIVES:(To determine the final outcome of poisoning including :)
研究者
Dr Shama Parveen bhat
Government medical college, Jammu
