HypothermiaNCT05203016
Complications Associated With Intraoperative Hypothermia.
An observational study of Hypothermia and Hemorrhage, Postpartum, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypothermia, Hemorrhage, Postpartum, Infection Surgical Wound
- What is being tested?
- Hipotermia/Normotermia
- How many people
- 402 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2019to 1 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients between 18 and 65 years old undergoing different types of surgeries (caesarean section / plastic and reparative / maxillofacial surgery) belonging to the Hospital Universitario la Paz will be monitored.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Complications Associated With Intraoperative Hypothermia in Obstetrics and Plastic and Maxillofacial Surgery. Unicentric Cohort Study.
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:
Read more
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.
- Conditions
- Hypothermia, Hemorrhage, Postpartum, Infection Surgical Wound, Transfusion-dependent Anemia
- Being tested
- Hipotermia/Normotermia
- Medical subject headings
- Hypothermia, Postpartum Hemorrhage, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hipotermia/NormotermiaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| caesarean sections | Not described Receives: Other: Hipotermia/Normotermia | |
| Plastic surgery | Not described Receives: Other: Hipotermia/Normotermia | |
| Maxillofacial surgery | Not described Receives: Other: Hipotermia/Normotermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypothermia
Body core temperature below 36ºC
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start1 Jan 2019
- Primary completion30 Oct 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203016
- Sponsor's protocol ID
- PI-3697
- Status last verified
- May 2019
- First submitted
- 29 Nov 2019
- Last updated
- 24 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complications Associated With Intraoperative Hypothermia in Obstetrics and Plastic and Maxillofacial Surgery. Unicentric Cohort Study.
- ClinicalTrials.gov ID
- NCT05203016
- Acronym / sponsor ID
- PI-3697
- Conditions
- Hypothermia, Hemorrhage, Postpartum, Infection Surgical Wound, Transfusion-dependent Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| caesarean sections | – | Other: Hipotermia/Normotermia |
| Plastic surgery | – | Other: Hipotermia/Normotermia |
| Maxillofacial surgery | – | Other: Hipotermia/Normotermia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between 18 and 65 years old undergoing different types of surgeries (caesarean section / plastic and reparative / maxillofacial surgery) belonging to the Hospital Universitario la Paz will be monitored.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hipotermia/NormotermiaThe 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. | Other | Maxillofacial surgery, Plastic surgery, caesarean sections |
Primary outcome
Hypothermia
Time frame: Through study completion, an average of 1 year.
Body core temperature below 36ºC
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothermia and Hemorrhage, Postpartum, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypothermia (time frame: Through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.