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Clinical Trials/CTRI/2021/12/038675
CTRI/2021/12/038675Not yet recruitingNot Applicable

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 site in 1 country500 target enrollmentStarted: December 27, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
500
Locations
1
Primary Endpoint
To find out the incidence of hypothermia during elective esophagectomy surgeries.

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 90.00 Year(s) (—)
Sex
All

Inclusion Criteria

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

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

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

Time Frame: 5 YEARS (4 YEARS RETROSPECTIVE AND 1 YEAR PROSPECTIVE)

Secondary Outcomes

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

Investigators

Sponsor
TAAT MEMORIAL CENTRE
Sponsor Class
Research institution and hospital

Study Sites (1)

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