HypothermiaNCT03050775
Evaluating Adult Patient Temperatures During Lower Spinal Surgery
A study testing Heated Ventilator Circuit and Standard Ventilator Circuit in people with Hypothermia, run by Mayo Clinic.
Trial summary
The purpose of this study is to evaluate patients' temperatures after using one of two ventilator circuits (breathing systems): the ANAPOD™ Heat and Humidification System (ANAPOD™ system) or the standard ventilator circuit with a heat-moisture exchanger (standard ventilator). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypothermia
- What is being tested?
- Heated Ventilator Circuit and Standard Ventilator Circuit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 28 Aug 2015to 5 Feb 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective spine surgery anticipated greater than three hours in duration
- Posterior approach
- An operative site between lumbar one and sacral one
- Involving two or more levels with fusion and/or instrumentation and/or revisions
- American Society of Anesthesiologists (ASA) Status of I-III
Who cannot join
- Patients with a tracheostomy
- Preoperative temperature >38°C or <36°C on the day of surgery
- Active infection or erythema to the back
- White blood cell count greater than 10,500/microliter (mcL)
About this study
Official title: Comparing Patient Temperatures in Adults During Lower Spinal Surgery Using Either a Heated Ventilator Circuit or a Standard Ventilator Circuit With a Heat-Moisture Exchanger
The purpose of this study is to evaluate patients' temperatures after using one of two ventilator circuits (breathing systems): the ANAPOD™ Heat and Humidification System (ANAPOD™ system) or the standard ventilator circuit with a heat-moisture exchanger (standard ventilator). The ANAPOD™ system will provide additional heat and humidity to patients through their breathing tube while the standard ventilator will not. The investigators are doing this research study to find out if the ventilator circuit providing additional heat and humidity will keep patients warmer during surgery and after surgery.
Read the detailed description
Patients were randomly assigned to either the treatment group or the control group prior to surgery. Prior to induction, patients in the control group were given inspiratory gas at ambient air temperature (20-22 degrees Celsius) and patients in the treatment group were given inspiratory gas at warmed temperatures (40-41 degrees Celsius). All patients were induced with general anesthesia in the supine position and repositioned prone following endotracheal intubation and placement of an esophageal stethoscope with a temperature sensor, as per usual hospital practice. Esophageal temperatures were recorded within 30 minutes of the baseline esophageal temperature and every 10 minutes thereafter for the first hour post-induction. All patients had a blanket and forced air warming applied to their lower extremities and upper back at 43 degrees Celsius after draping. All patients had esophageal temperature measurements recorded every 30 minutes until the patient was repositioned supine. Core temperatures were recorded four hours post-induction for those patients reaching that timeframe.
- Conditions
- Hypothermia
- Being tested
- Heated Ventilator Circuit, Standard Ventilator Circuit
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heated Ventilator CircuitDevice
Also called ANAPOD™ Heat and Humidification System
active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger
Standard Ventilator CircuitDevice
Also called Thermovent 600; Portex
no active heat and humidification during anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Heated Ventilator Circuit | Experimental | Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management. Receives: Device: Heated Ventilator Circuit |
| Standard Ventilator Circuit | Active comparator | Standard ventilation and temperature management. Receives: Device: Standard Ventilator Circuit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core Body Temperature
Core body temperature will be taken in the esophagus. The last recorded esophageal temperature will be used for surgeries not reaching 3 hours duration.
Measured: Approximately four hours post-induction of general anesthesia (or last recorded temperature)
Secondary outcomes (6)
Intraoperative Core Temperatures Post-induction
Core body temperature will be taken in the esophagus after general anesthesia induction.
Measured: Approximately 30 minutes, 60 minutes, 120 minutes post-induction of general anesthesia
Number of Subjects With Post-operative Shivering
Shivering in the post-anesthesia care unit will be assessed using the Bedside Shivering Assessment Scale. This is a 4 point scale and rate shivering as the following: absent, mild, moderate, or severe. Only the highest degree of patient shivering was used in the analysis.
Measured: Approximately 2 hours after completion of the surgery
Hospital Length of Stay
Number of days in the hospital
Measured: Surgery to hospital discharge
Overall Post-operative Temperature
Temperature at Post Anesthesia Care Unit (PACU) arrival.
Measured: PACU arrival
Number of Participants With Transfusion Within 48 Hours of Surgery
Requirement of blood transfusion within 48 hours of surgery
Measured: Within 48 hours of surgery
Estimated Blood Loss
The estimated blood loss per case was determined by the anesthesia provider by measuring the volume of blood in the suction canister while taking into account the amount of irrigation solution used.
Measured: duration of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start28 Aug 2015
- Primary completion5 Feb 2017
- Study completion5 Feb 2017
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.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Model description
- randomized, trial (treatment or no treatment)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Westmed, Inc.
- Responsible party
- Principal investigator, Jean M. Guyer, Mayo Clinic
- Investigators
- Jean M Guyer, DNP, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050775
- Sponsor's protocol ID
- 15-001604
- Other IDs
- UL1TR000135
- Status last verified
- May 2018
- First submitted
- 9 Feb 2017
- Last updated
- 7 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Patient Temperatures in Adults During Lower Spinal Surgery Using Either a Heated Ventilator Circuit or a Standard Ventilator Circuit With a Heat-Moisture Exchanger
- ClinicalTrials.gov ID
- NCT03050775
- Acronym / sponsor ID
- 15-001604
- Conditions
- Hypothermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Westmed, Inc.
- Study start
- 28 Aug 2015 (actual)
- Primary completion
- 5 Feb 2017 (actual)
- Study completion
- 5 Feb 2017 (actual)
- First posted
- 13 Feb 2017 (actual)
- Results
- Posted 7 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate patients' temperatures after using one of two ventilator circuits (breathing systems): the ANAPOD™ Heat and Humidification System (ANAPOD™ system) or the standard ventilator circuit with a heat-moisture exchanger (standard ventilator). The ANAPOD™ system will provide additional heat and humidity to patients through their breathing tube while the standard ventilator will not. The investigators are doing this research study to find out if the ventilator circuit providing additional heat and humidity will keep patients warmer during surgery and after surgery.
Detailed description
Patients were randomly assigned to either the treatment group or the control group prior to surgery. Prior to induction, patients in the control group were given inspiratory gas at ambient air temperature (20-22 degrees Celsius) and patients in the treatment group were given inspiratory gas at warmed temperatures (40-41 degrees Celsius). All patients were induced with general anesthesia in the supine position and repositioned prone following endotracheal intubation and placement of an esophageal stethoscope with a temperature sensor, as per usual hospital practice. Esophageal temperatures were recorded within 30 minutes of the baseline esophageal temperature and every 10 minutes thereafter for the first hour post-induction. All patients had a blanket and forced air warming applied to their lower extremities and upper back at 43 degrees Celsius after draping. All patients had esophageal temperature measurements recorded every 30 minutes until the patient was repositioned supine. Core temperatures were recorded four hours post-induction for those patients reaching that timeframe.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, trial (treatment or no treatment)
| Arm | Type | Receives |
|---|---|---|
| Heated Ventilator Circuit | Experimental | Device: Heated Ventilator CircuitHeated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management. |
| Standard Ventilator Circuit | Active comparator | Device: Standard Ventilator CircuitStandard ventilation and temperature management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Elective spine surgery anticipated greater than three hours in duration
- Posterior approach
- An operative site between lumbar one and sacral one
- Involving two or more levels with fusion and/or instrumentation and/or revisions
- American Society of Anesthesiologists (ASA) Status of I-III
Key exclusion criteria (4 listed)
- Patients with a tracheostomy
- Preoperative temperature >38°C or <36°C on the day of surgery
- Active infection or erythema to the back
- White blood cell count greater than 10,500/microliter (mcL)
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 |
|---|---|---|
| Heated Ventilator CircuitAlso: ANAPOD™ Heat and Humidification Systemactive heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger | Device | Heated Ventilator Circuit |
| Standard Ventilator CircuitAlso: Thermovent 600; Portexno active heat and humidification during anesthesia | Device | Standard Ventilator Circuit |
Primary outcome
Core Body Temperature
Time frame: Approximately four hours post-induction of general anesthesia (or last recorded temperature)
Core body temperature will be taken in the esophagus. The last recorded esophageal temperature will be used for surgeries not reaching 3 hours duration.
6 secondary outcomes
Intraoperative Core Temperatures Post-induction
Time frame: Approximately 30 minutes, 60 minutes, 120 minutes post-induction of general anesthesia
Number of Subjects With Post-operative Shivering
Time frame: Approximately 2 hours after completion of the surgery
Hospital Length of Stay
Time frame: Surgery to hospital discharge
Overall Post-operative Temperature
Time frame: PACU arrival
Number of Participants With Transfusion Within 48 Hours of Surgery
Time frame: Within 48 hours of surgery
Estimated Blood Loss
Time frame: duration of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jean M Guyer, DNP principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Heated Ventilator Circuit and Standard Ventilator Circuit in people with Hypothermia, run by Mayo Clinic.
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 4 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 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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 7 May 2018). 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?
Core Body Temperature (time frame: Approximately four hours post-induction of general anesthesia (or last recorded temperature)). 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 7 May 2018.