Complications Associated With Intraoperative Hypothermia.

Hypothermia Clinical Trial

Official title:

Complications Associated With Intraoperative Hypothermia in Obstetrics and Plastic and Maxillofacial Surgery. Unicentric Cohort Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05203016
• Other study ID #: PI-3697
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: January 1, 2020

Study information

• Verified date: May 2019
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Maintaining intraoperative normothermia and temperature measurement is a marker of quality of care. We know that intraoperative hypothermia is associated with an increased risk of cardiovascular events, infection of the surgical wound, a longer hospital stay, discomfort, hemorrhage and transfusion demand.

Goals:

To know the incidence of perioperative hypothermia in routine clinical practice in different surgical settings in a national reference university hospital.

To establish if hypothermia is a risk factor for developing postoperative complications, focusing mainly on bleeding and infection of the surgical wound, in subjects aged between 18-65 years who come to the La Paz University Hospital for a surgical intervention in the Obstetrics / Plastic and Maxillofacial Surgery Services.

Hospital-based cohort study. A two-year follow-up of patients between 18 and 65 years will be carried out. Those patients with haemostasis disorders and infections in the preoperative period will be excluded.

Using a questionnaire on sociodemographic variables, the baseline conditions of the patients will be evaluated for inclusion in the study. Subsequently, the temperature will be measured at the beginning and at the end of the surgery, as well as during admission to the Post Anesthesia Care Unit, where the temperature normalization time will be noted in the event of hypothermia. In retrospect, those variables corresponding to the late postoperative period will be evaluated and the telephone interview will be conducted to assess the quality of care received. All the data will be reflected in the collection booklet that we present in the annex.

Patient demographics, case characteristics, and temperature records were summarized using descriptive statistics.

Microsoft Excel (Professional Plus 2010, version 14); it was used for data management and processing, with Stata (version 14; StataCorp LP, College Station, TX) for graphical representations and statistical tests. A multivariate analysis of potential confounding factors will be performed.

These results will serve to know the incidence of hypothermia according to the usual practice in a Spanish tertiary hospital and to establish recommendations in the management of intraoperative hypothermia and its prevention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: January 1, 2020
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients aged between 18 and 65 years, of any ethnic origin, with any type of comorbidities, with surgical indication in the Plastic, Maxillofacial and Obstetrics Surgery services scheduled or emergency under any mode of anesthesia (spinal, epidural, spinal combined or general anesthesia), following the usual practice of the service.

• That you agree to participate in the study by signing the informed consent.

Exclusion Criteria:

• Children under 18 or over 65 years of age, having received active prewarming in the preoperative period, received anti-fibrinolytic treatment, with bleeding diathesis, untreated perioperative anemia, preoperative perinatal infections and / or requiring intraoperative blood transfusion.

• Patients who for any reason should not be included in the study according to the evaluation of the research team and / or who refuse to participate in the study.

Related Conditions & MeSH terms

• Hemorrhage
• Hemorrhage, Postpartum
• Hypothermia
• Postpartum Hemorrhage
• Surgical Wound
• Surgical Wound Infection
• Transfusion-dependent Anemia

Intervention

Other:
• Hipotermia/Normotermia
The temperature will be measured at the beginning and at the end of the surgery, as well as during admission to the Post-Anesthesia Care Unit, where the temperature normalization time will be noted in the event of hypothermia. In retrospect, those variables corresponding to the late postoperative period will be evaluated and the telephone interview will be conducted to assess the quality of care received. All the data will be reflected in the collection booklet that we present in the annex.

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypothermia	Body core temperature below 36ºC	Through study completion, an average of 1 year.