跳至主要内容
临床试验/CTRI/2021/12/038675
CTRI/2021/12/038675尚未招募不适用

An observational study to find out the incidence, causes and effects of intra-operativehypothermia during elective esophagectomy at a tertiary care centre.

TAAT MEMORIAL CENTRE1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年12月27日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
500
试验地点
1
主要终点
To find out the incidence of hypothermia during elective esophagectomy surgeries.

研究概览

简要总结

Meta-analyses and randomized controlled trials have shown that intraoperative hypothermia is correlated

with occurrence of wound infection, cardiac morbidities, bleeding and transfusion requirement,

shivering and increased post-operative discomfort, negative catabolism and nitrogen balance, and

an overall higher mortality. Consequently, perioperative temperature monitoring and

avoidance of intraoperative hypothermia are recognized as worthy quality improvement measures

aimed at optimizing surgical care.

Many perioperative factors make the patient prone for intraoperative hypothermia during

esophagectomy surgeries. These include- preoperative weight loss, alopecia due to neo-adjuvant

chemotherapy, long duration of surgery, opening of two body cavities (thorax and abdomen) use

of capnothorax and/or pneumo- peritoneum, and blood loss during the surgeries. Mild hypothermia

(core temperature between 34-36 degrees Celsius) is noted in 20-50% of patients undergoing

esophageal surgeries. [4] Measures to avoid hypothermia include pre-emptive skin warming,

maintenance of operating room temperature at 21 °C or 69.8 °F, humidification of airway,

intravenous fluid warming, applying blanket for skin coverage, forced-air convective warming

system, circulating water mattresses, circulating water garments, or combinations of methods [5]

In this context, we would conduct a amphi-directional (4 years retrospective and one year

prospective) observational study to find the incidence of hypothermia, the causes for the

hypothermia and its effect on the early post-operative complications in adult patients undergoing

esophagostomies at tertiary care cancer centre

Following data will be collected:

a. Demographic data (age, sex, weight, height, BMI)

b. Pre-operative data: like pre-operative weight loss,preoperative co-morbidities, details of neo-adjuvant treatment

c. Intra-operative data temperature recording and temperature maintaining devices

d. Details of core body temperature record every one hour during the duration of surgery

e. Details of any intra-operative complication (need for vasopressors, arrhythmia,

desaturation etc.)

f. Post-operative details: like shivering, respiratory and cardiac complications, surgical site infections

Demographic data will be analyzed using frequencies, and the averages with measurements of

dispersion of data.

Descriptive data will be analyzed using frequencies, means, standard deviations and ranges.

Association between various factors and the hypothermia will be tested by multivariate analysis to

find out independently associated factors.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • •All adult patients undergoing elective esophagectomy surgery at TMH.

排除标准

  • •refusal of consent, emergency surgeries, inoperability after exploration, and performing any other procedure in addition to esophagectomy.
  • •Those patients with the missing data will not be considered for analysis.

结局指标

主要结局

To find out the incidence of hypothermia during elective esophagectomy surgeries.

时间窗: 5 YEARS (4 YEARS RETROSPECTIVE AND 1 YEAR PROSPECTIVE)

次要结局

  • To find out the association between various pre-operative and intra-operative factors and(the incidence of hypothermia during esophageal surgeries.)

研究者

发起方
TAAT MEMORIAL CENTRE
申办方类型
Research institution and hospital

研究点 (1)

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