HypothermiahypothermiaNCT02091466
Pre-warming Prevents Hypothermia in Elective Cesarean Section
A study testing pre-warming in people with Hypothermia, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
Trial summary
Background: Hypothermia is common during general and regional anesthesia even when active warming measures are taken. The existing literature shows that, in pregnant patients, the use of forced air-warming during cesarean section under spinal anesthesia does not prevent maternal hypothermia. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Hypothermia
- What is being tested?
- pre-warming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2010to Jul 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant women
- between 18 and 40 years of age
- singleton pregnancy
- gestation longer than 37 weeks
- elective cesarean section
Who cannot join
- fever and/or infectious conditions
- familial history of potential malignant hyperthermia
- body mass index (BMI) values below 18.5 kg.cm-2 or above 36 kg.cm-2
- thyroid disorders, dysautonomia, Raynaud's syndrome
- patient in labor
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Irmandade Santa Casa de Misericórdia de São Paulo
São Paulo, São Paulo, 01221020
About this study
Official title: Pre-warming With Thermal Gown Prevents Maternal Hypothermia in Elective Cesarean Section
Background: Hypothermia is common during general and regional anesthesia even when active warming measures are taken. The existing literature shows that, in pregnant patients, the use of forced air-warming during cesarean section under spinal anesthesia does not prevent maternal hypothermia. Therefore, this study aimed to establish the efficacy of a pre-warming system, initiated 30 minutes before the onset of spinal anesthesia and during surgery, in pregnant women subjected to elective cesarean delivery.
Methods: Forty healthy pregnant patients undergoing elective cesarean section with spinal anesthesia were allocated to the control group (Gcont, n = 20), without the use of a thermal gown, and to the gown group (Ggown, n = 20), with the use of a thermal gown in the preoperative care unit, 30 minutes before spinal anesthesia installation and during surgery. After the anesthesia, the thermal gown was moved from the regular position and placed over the chest and upper limbs, as an upper body blanket, and maintained throughout the study. The following variables were observed: preoperative and operative room temperature, hemoglobin saturation, heart rate, arterial pressure, tympanic temperature in the preoperative care unit room (baseline) and at 0, 15, 30, 45 and 60 minutes after spinal anesthesia. Repeated Measure ANCOVA compared temperatures of each group, adjusted for baseline values.
Read the detailed description
Introduction Body temperature decreasing following the onset of general or regional anesthesia is caused by a core-to-peripheral redistribution of heat, as demonstrated by several previous studies. Perioperative hypothermia and its complications have been widely studied in patients subjected to non-obstetric surgery; however, literature on the obstetric population is rare, although the incidence of intraoperative shivering can be as high as 60% in these patients. A previous study based on the use of forced air-warming unit during the preoperative and intraoperative periods in patients subjected to cesarean delivery observed a lower incidence of hypothermia and shivering in patients given epidural anesthesia when compared to those given spinal anesthesia.
The forced air system is by far the most commonly used intraoperative warming approach and has an admirable safety record. However, the problem with blanket-forced air warming, circulating-water garments, or water mattresses is that it is impossible to change their position on the bed, which can be uncomfortable, especially if the patient is waiting in a sitting position.
The Bair Paws Gown® presents an air warming system that provides patient-controlled comfort warming in the pre and postoperative setting. The same gown offers effective clinical warming during surgery involving the head, neck, knees or extremities. The air-warming flows through the gown, from knees to head or from head to knees, and allows the patient to be seated with gown covering the area between knees and neck.
Therefore, we designed a study to establish the efficacy of a pre-warming system that keeps the garment throughout the perioperative period, without interruption, initiated 30 minutes before the induction of spinal anesthesia for elective cesarean delivery. The aim of this study was to test the hypothesis that active warming 30 minutes before spinal anesthesia should better prevent a fall in pregnant body temperature. A secondary goal evaluated the incidence of shivering, as well as thermal comfort during the procedure.
Methods After obtaining Institutional Review Board approval (record 388/08) and written informed consent from patients, 40 healthy ASA physical status I or II pregnant women presenting for scheduled cesarean delivery under spinal anesthesia were enrolled in this prospective, randomized study.
Randomization (1:1) was based on a random computer generated code that was maintained in sequentially numbered opaque envelopes.
Eligible participants were pregnant women between 18 and 40 years of age, with singleton pregnancy and gestation longer than 37 weeks, scheduled for elective cesarean section. Patients with fever and/or infectious conditions, a familial history of potential malignant hyperthermia, body mass index (BMI) values below 18.5 kg.cm-2 or above 36 kg.cm-2, thyroid disorders, dysautonomia, Raynaud's syndrome, and those in labor were excluded.
Participants remained seated in the preoperative care unit until they were allocated to one of the following groups: control group (Gcont n = 20), in which surgery was performed without the use of a thermal gown, or gown group (Ggown n = 20), in which surgery was performed while the patients were covered with a thermal gown (Bair Paws Standard Warming Gown 810 model with a Bair Hugger, model 850 warming unit) with forced-air flow at 40ºC in the preoperative care unit 30 minutes before the spinal anesthesia. When the patients were transferred to the operative room, the warming gown was switched off for the gown group; however, the gown was maintained in place and, when the pregnant women arrived in operative room, the system was switched back on and the gown was moved to the anterior part of the body, covering chest and upper limbs as an upper body blanket, which was maintained until the end of surgery.
In the operative room, a venous cannula was inserted into the forearm, and an infusion of Ringer's lactate solution fluids at 37ºC was initiated. Spinal anesthesia was administered using 10 mg of hyperbaric bupivacaine, combined with 10 µg of fentanyl and 80 µg of morphine. Puncture was performed at level L1-L2 or L2-L3 of the lumbar vertebra, and surgery began when the sensory blockage reached a level between the T4 and T6 thoracic vertebra, as established by the loss of sensitivity to needle pricks. Intraoperative hydration used 500 ml of 40ºC Ringer's lactate solution before fetal extraction and 800 µg metaraminol was provided via slow infusion or 400 µg was delivered as an IV bolus whenever the arterial pressure decreased by more than 25% of the baseline value. Following fetal extraction but before the end of surgery, 1,000 ml of Ringer's lactate solution with 20 IU of oxytocin was infused.
Demographic variables included age, weight, height and BMI. Patients were monitored with hemoglobin peripheral saturation (SpO2), heart rate (HR), noninvasive systolic arterial pressure (SAP) and diastolic arterial pressure (DAP). The tympanic temperature was measured by means of a digital thermometer (Techline Model TS 201, Sao Paulo, SP, Brazil) Ambient temperature was maintained approximately at 22ºC according to wall thermostat (ABNT NBR 7256 - Brazilian regulatory and normalization Agency).
All data were assessed at baseline, 30 minutes before induction of spinal anesthesia; T0 (immediately after the spinal anesthesia); and T15, T30, T45, and T60 (15, 30, 45, and 60 minutes following the onset of spinal anesthesia, respectively).
In addition, postoperative data were assessed during the admission to the post-anesthesia care unit (PACU). Shivering was evaluated according to Wrench's scale that uses: 0 - no shivering; 1 - one or more symptoms of piloerection, peripheral vasoconstriction, and peripheral cyanosis without any other cause and without visible muscular activity; 2 - visible muscular activity confined to one muscle group; 3 - visible muscular activity in more than one muscle group; and 4 - gross muscular activity involving the entire body. Thermal discomfort according to Horn's verbal numerical scale: 0 - worst imaginable cold, 100 - insufferably hot and adverse effects during the immediate postoperative period were also registered. Moreover, patients received 12.5-25 mg meperidine whenever their shivering scores were equal to or greater than three.
Sample size was calculated to be 20 participants to ensure that a difference of 0.5ºC could be detected at significance level of 5%, with a statistical power of 80%, assuming the standard deviation of differences to be 0.5ºC.
Data are presented as mean and standard deviation or median and interquartile interval (25-75) according to tested distribution (Shapiro-Wilk test). Analysis of covariance for repeated measures (ANCOVA), adjusted for baseline values, compared tympanic temperatures between the groups. Statistical significance was established at p < 0.05, and the statistical analysis was performed using SPSS (Statistical Package for the Social Sciences) software version 20.
- Conditions
- Hypothermia
- Being tested
- pre-warming
- Keywords
- Hypothermia, Perioperative Care, Anesthesia, Spinal, Rewarming
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre-warmingDevice
warming patients 30 minutes prior to anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Pre-warming | Active comparator | The intervention is to warm patients before the anesthesia procedure in experimental groups Receives: Device: pre-warming |
| Control | No intervention | Patients received no active warming before the anesthesia procedure in control groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Hypothermia
Hypothermia was measured by means of tympanic temperatures.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startMar 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Caio Gracco De Bernardis, Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Investigators
- Ricardo Caio G De Bernardis, M.D. Ph.D, Principal investigator, Irmandade Santa Casa deMisericórdia de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091466
- Sponsor's protocol ID
- 388/08 - FCMSCSP
- Acronym
- hypothermia
- Status last verified
- Sep 2014
- First submitted
- 13 Mar 2014
- Last updated
- 2 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-warming With Thermal Gown Prevents Maternal Hypothermia in Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT02091466
- Acronym / sponsor ID
- hypothermia / 388/08 - FCMSCSP
- Conditions
- Hypothermia
- Keywords
- Hypothermia, Perioperative Care, Anesthesia, Spinal, Rewarming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São PauloUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 19 Mar 2014 (estimated)
- Results
- Posted 2 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Hypothermia is common during general and regional anesthesia even when active warming measures are taken. The existing literature shows that, in pregnant patients, the use of forced air-warming during cesarean section under spinal anesthesia does not prevent maternal hypothermia. Therefore, this study aimed to establish the efficacy of a pre-warming system, initiated 30 minutes before the onset of spinal anesthesia and during surgery, in pregnant women subjected to elective cesarean delivery.
Methods: Forty healthy pregnant patients undergoing elective cesarean section with spinal anesthesia were allocated to the control group (Gcont, n = 20), without the use of a thermal gown, and to the gown group (Ggown, n = 20), with the use of a thermal gown in the preoperative care unit, 30 minutes before spinal anesthesia installation and during surgery. After the anesthesia, the thermal gown was moved from the regular position and placed over the chest and upper limbs, as an upper body blanket, and maintained throughout the study. The following variables were observed: preoperative and operative room temperature, hemoglobin saturation, heart rate, arterial pressure, tympanic temperature in the preoperative care unit room (baseline) and at 0, 15, 30, 45 and 60 minutes after spinal anesthesia. Repeated Measure ANCOVA compared temperatures of each group, adjusted for baseline values.
Detailed description
Introduction Body temperature decreasing following the onset of general or regional anesthesia is caused by a core-to-peripheral redistribution of heat, as demonstrated by several previous studies. Perioperative hypothermia and its complications have been widely studied in patients subjected to non-obstetric surgery; however, literature on the obstetric population is rare, although the incidence of intraoperative shivering can be as high as 60% in these patients. A previous study based on the use of forced air-warming unit during the preoperative and intraoperative periods in patients subjected to cesarean delivery observed a lower incidence of hypothermia and shivering in patients given epidural anesthesia when compared to those given spinal anesthesia.
The forced air system is by far the most commonly used intraoperative warming approach and has an admirable safety record. However, the problem with blanket-forced air warming, circulating-water garments, or water mattresses is that it is impossible to change their position on the bed, which can be uncomfortable, especially if the patient is waiting in a sitting position.
The Bair Paws Gown® presents an air warming system that provides patient-controlled comfort warming in the pre and postoperative setting. The same gown offers effective clinical warming during surgery involving the head, neck, knees or extremities. The air-warming flows through the gown, from knees to head or from head to knees, and allows the patient to be seated with gown covering the area between knees and neck.
Therefore, we designed a study to establish the efficacy of a pre-warming system that keeps the garment throughout the perioperative period, without interruption, initiated 30 minutes before the induction of spinal anesthesia for elective cesarean delivery. The aim of this study was to test the hypothesis that active warming 30 minutes before spinal anesthesia should better prevent a fall in pregnant body temperature. A secondary goal evaluated the incidence of shivering, as well as thermal comfort during the procedure.
Methods After obtaining Institutional Review Board approval (record 388/08) and written informed consent from patients, 40 healthy ASA physical status I or II pregnant women presenting for scheduled cesarean delivery under spinal anesthesia were enrolled in this prospective, randomized study.
Randomization (1:1) was based on a random computer generated code that was maintained in sequentially numbered opaque envelopes.
Eligible participants were pregnant women between 18 and 40 years of age, with singleton pregnancy and gestation longer than 37 weeks, scheduled for elective cesarean section. Patients with fever and/or infectious conditions, a familial history of potential malignant hyperthermia, body mass index (BMI) values below 18.5 kg.cm-2 or above 36 kg.cm-2, thyroid disorders, dysautonomia, Raynaud's syndrome, and those in labor were excluded.
Participants remained seated in the preoperative care unit until they were allocated to one of the following groups: control group (Gcont n = 20), in which surgery was performed without the use of a thermal gown, or gown group (Ggown n = 20), in which surgery was performed while the patients were covered with a thermal gown (Bair Paws Standard Warming Gown 810 model with a Bair Hugger, model 850 warming unit) with forced-air flow at 40ºC in the preoperative care unit 30 minutes before the spinal anesthesia. When the patients were transferred to the operative room, the warming gown was switched off for the gown group; however, the gown was maintained in place and, when the pregnant women arrived in operative room, the system was switched back on and the gown was moved to the anterior part of the body, covering chest and upper limbs as an upper body blanket, which was maintained until the end of surgery.
In the operative room, a venous cannula was inserted into the forearm, and an infusion of Ringer's lactate solution fluids at 37ºC was initiated. Spinal anesthesia was administered using 10 mg of hyperbaric bupivacaine, combined with 10 µg of fentanyl and 80 µg of morphine. Puncture was performed at level L1-L2 or L2-L3 of the lumbar vertebra, and surgery began when the sensory blockage reached a level between the T4 and T6 thoracic vertebra, as established by the loss of sensitivity to needle pricks. Intraoperative hydration used 500 ml of 40ºC Ringer's lactate solution before fetal extraction and 800 µg metaraminol was provided via slow infusion or 400 µg was delivered as an IV bolus whenever the arterial pressure decreased by more than 25% of the baseline value. Following fetal extraction but before the end of surgery, 1,000 ml of Ringer's lactate solution with 20 IU of oxytocin was infused.
Demographic variables included age, weight, height and BMI. Patients were monitored with hemoglobin peripheral saturation (SpO2), heart rate (HR), noninvasive systolic arterial pressure (SAP) and diastolic arterial pressure (DAP). The tympanic temperature was measured by means of a digital thermometer (Techline Model TS 201, Sao Paulo, SP, Brazil) Ambient temperature was maintained approximately at 22ºC according to wall thermostat (ABNT NBR 7256 - Brazilian regulatory and normalization Agency).
All data were assessed at baseline, 30 minutes before induction of spinal anesthesia; T0 (immediately after the spinal anesthesia); and T15, T30, T45, and T60 (15, 30, 45, and 60 minutes following the onset of spinal anesthesia, respectively).
In addition, postoperative data were assessed during the admission to the post-anesthesia care unit (PACU). Shivering was evaluated according to Wrench's scale that uses: 0 - no shivering; 1 - one or more symptoms of piloerection, peripheral vasoconstriction, and peripheral cyanosis without any other cause and without visible muscular activity; 2 - visible muscular activity confined to one muscle group; 3 - visible muscular activity in more than one muscle group; and 4 - gross muscular activity involving the entire body. Thermal discomfort according to Horn's verbal numerical scale: 0 - worst imaginable cold, 100 - insufferably hot and adverse effects during the immediate postoperative period were also registered. Moreover, patients received 12.5-25 mg meperidine whenever their shivering scores were equal to or greater than three.
Sample size was calculated to be 20 participants to ensure that a difference of 0.5ºC could be detected at significance level of 5%, with a statistical power of 80%, assuming the standard deviation of differences to be 0.5ºC.
Data are presented as mean and standard deviation or median and interquartile interval (25-75) according to tested distribution (Shapiro-Wilk test). Analysis of covariance for repeated measures (ANCOVA), adjusted for baseline values, compared tympanic temperatures between the groups. Statistical significance was established at p < 0.05, and the statistical analysis was performed using SPSS (Statistical Package for the Social Sciences) software version 20.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-warming | Active comparator | Device: pre-warmingThe intervention is to warm patients before the anesthesia procedure in experimental groups |
| Control | No intervention | –Patients received no active warming before the anesthesia procedure in control groups |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- pregnant women
- between 18 and 40 years of age
- singleton pregnancy
- gestation longer than 37 weeks
- elective cesarean section
Key exclusion criteria (5 listed)
- fever and/or infectious conditions
- familial history of potential malignant hyperthermia
- body mass index (BMI) values below 18.5 kg.cm-2 or above 36 kg.cm-2
- thyroid disorders, dysautonomia, Raynaud's syndrome
- patient in labor
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 |
|---|---|---|
| pre-warmingwarming patients 30 minutes prior to anesthesia | Device | Pre-warming |
Primary outcome
Maternal Hypothermia
Time frame: 60 minutes
Hypothermia was measured by means of tympanic temperatures.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ricardo Caio G De Bernardis, M.D. Ph.D principal investigator
Irmandade Santa Casa deMisericórdia de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pre-warming in people with Hypothermia, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
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 5 inclusion and 5 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 2 Nov 2015. 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 Brazil. 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?
Yes. Results are posted in the registry (first posted 2 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maternal Hypothermia (time frame: 60 minutes). 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 2 Nov 2015.