NCT05203016

Complications Associated With Intraoperative Hypothermia.

Completed Last updated 24 January 2022

What this trial tests

trial testing Hipotermia/Normotermia in Hypothermia in 402 participants. Completed in 1 January 2020.

Timeline

1 January 2019

Primary endpoint
30 October 2019

1 January 2020

Quick facts

Lead sponsor	Instituto de Investigación Hospital Universitario La Paz
Status	Completed
Study type	OBSERVATIONAL
Enrollment	402
Start date	1 January 2019
Primary completion	30 October 2019
Estimated completion	1 January 2020
Sites	1 location across Spain

Drugs / interventions tested

• Hipotermia/Normotermia

Conditions studied

• Hypothermia — all drugs for Hypothermia →
• Hemorrhage, Postpartum — all drugs for Hemorrhage, Postpartum →
• Infection Surgical Wound — all drugs for Infection Surgical Wound →
• Transfusion-dependent Anemia — all drugs for Transfusion-dependent Anemia →

Sponsor

Instituto de Investigación Hospital Universitario La Paz

Who can join

Adults 18 to 65, any sex, with Hypothermia or Hemorrhage, Postpartum. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.