Non-cardiac SurgeryNCT02743884
Evaluating Heat Transfer With the Esophageal Cooling Device
A study testing Esophageal Warming and Esophageal Cooling in people with Non-cardiac Surgery, run by The Cleveland Clinic at 1 site in United States.
Trial summary
An esophageal heat exchange tube will be inserted in anesthetized surgical patients. Each patient will have 30 minutes of cooling (circulating fluid at 7 degrees C) and 30 minutes of warming (42 degrees C) with 15-minute recovery break in between. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-cardiac Surgery
- What is being tested?
- Esophageal Warming and Esophageal Cooling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Jan 2017
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective non-cardiac surgery;
- Age 18-80 years;
- Surgery expected to last >2 hours;
- General anesthesia with endotracheal Intubation;
- Volatile anesthesia;
- BMI < 38 kg/m2;
- ASA physical status 1-3.
Who cannot join
- Weight < 45 kg;
- Unstable blood pressure;
- Known esophageal deformity or evidence of esophageal trauma or esophageal disease that in the opinion of the attending anesthesiologist precludes safe use of ECD.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Interventional Study Evaluating Heat Transfer With the Esophageal Cooling Device
An esophageal heat exchange tube will be inserted in anesthetized surgical patients. Each patient will have 30 minutes of cooling (circulating fluid at 7 degrees C) and 30 minutes of warming (42 degrees C) with 15-minute recovery break in between. The primary outcome will be heat transfer, determined from inflow and outflow temperatures and fluid flow rate for cooling and warming modes.
Read the detailed description
The ECD is made with medical-grade silicone and has 3 ports; 2 coolant ports and a central port. The coolant ports of the ECD are connected to external heat exchanger while a third, central lumen simultaneously allows gastric decompression and drainage. The ECD can be inserted like a standard gastric tube.
The aim of this prospective, interventional study is to quantify heat transfer during warming and cooling using the Esophageal Cooling Device in anesthetized patients having non-cardiac surgery.
An esophageal heat exchange tube will be inserted in anesthetized surgical patients. Each will have 30 minutes of cooling (circulating fluid at 7 degrees C) and 30 minutes of warming (42 degrees C) with 15 -minute break in between; the order of the cooling and warming will be randomized. The primary outcome will be heat transfer, determined from inflow and outflow fluid temperatures and fluid flow rate assessed for both cooling and warming modes.
- Conditions
- Non-cardiac Surgery
- Being tested
- Esophageal Warming, Esophageal Cooling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal WarmingDevice
30 minutes of warming from circulating water at about 42 degrees C through an esophageal heat exchanger.
Esophageal CoolingDevice
30 minutes of cooling from circulating water at about 7 degrees C through an esophageal heat exchanger.
| Study group | Role | What they receive |
|---|---|---|
| Esophageal Cooling Device | Experimental | Esophageal cooling Receives: Device: Esophageal Cooling |
| Esophageal Warming | Experimental | Esophageal warming Receives: Device: Esophageal Warming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean heat transfer at cooling, kcal/h
Heat transfer is calculated as difference between inflow and outflow temperatures, multiplied by flow and the specific heat of water
Measured: 15-60 minutes after intubation during elective non-cardiac surgery
Mean heat transfer at warming, kcal/h
Heat transfer is calculated as difference between inflow and outflow temperatures, multiplied by flow and the specific heat of water
Measured: 15-60 minutes after intubation during elective non-cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by The Cleveland 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Cross-over.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, d sessler, The Cleveland Clinic
- Investigators
- Daniel Sessler, M.D., Study chair, Dept Chairman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743884
- Sponsor's protocol ID
- 16-124
- Status last verified
- Apr 2017
- First submitted
- 14 Apr 2016
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Interventional Study Evaluating Heat Transfer With the Esophageal Cooling Device
- ClinicalTrials.gov ID
- NCT02743884
- Acronym / sponsor ID
- 16-124
- Conditions
- Non-cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 19 Apr 2016 (estimated)
- 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.
An esophageal heat exchange tube will be inserted in anesthetized surgical patients. Each patient will have 30 minutes of cooling (circulating fluid at 7 degrees C) and 30 minutes of warming (42 degrees C) with 15-minute recovery break in between. The primary outcome will be heat transfer, determined from inflow and outflow temperatures and fluid flow rate for cooling and warming modes.
Detailed description
The ECD is made with medical-grade silicone and has 3 ports; 2 coolant ports and a central port. The coolant ports of the ECD are connected to external heat exchanger while a third, central lumen simultaneously allows gastric decompression and drainage. The ECD can be inserted like a standard gastric tube.
The aim of this prospective, interventional study is to quantify heat transfer during warming and cooling using the Esophageal Cooling Device in anesthetized patients having non-cardiac surgery.
An esophageal heat exchange tube will be inserted in anesthetized surgical patients. Each will have 30 minutes of cooling (circulating fluid at 7 degrees C) and 30 minutes of warming (42 degrees C) with 15 -minute break in between; the order of the cooling and warming will be randomized. The primary outcome will be heat transfer, determined from inflow and outflow fluid temperatures and fluid flow rate assessed for both cooling and warming modes.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cross-over.
| Arm | Type | Receives |
|---|---|---|
| Esophageal Cooling Device | Experimental | Device: Esophageal CoolingEsophageal cooling |
| Esophageal Warming | Experimental | Device: Esophageal WarmingEsophageal warming |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Elective non-cardiac surgery;
- Age 18-80 years;
- Surgery expected to last >2 hours;
- General anesthesia with endotracheal Intubation;
- Volatile anesthesia;
Key exclusion criteria (3 listed)
- Weight < 45 kg;
- Unstable blood pressure;
- Known esophageal deformity or evidence of esophageal trauma or esophageal disease that in the opinion of the attending anesthesiologist precludes safe use of ECD.
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 |
|---|---|---|
| Esophageal Warming30 minutes of warming from circulating water at about 42 degrees C through an esophageal heat exchanger. | Device | Esophageal Warming |
| Esophageal Cooling30 minutes of cooling from circulating water at about 7 degrees C through an esophageal heat exchanger. | Device | Esophageal Cooling Device |
Primary outcome
Mean heat transfer at cooling, kcal/h
Time frame: 15-60 minutes after intubation during elective non-cardiac surgery
Heat transfer is calculated as difference between inflow and outflow temperatures, multiplied by flow and the specific heat of water
Mean heat transfer at warming, kcal/h
Time frame: 15-60 minutes after intubation during elective non-cardiac surgery
Heat transfer is calculated as difference between inflow and outflow temperatures, multiplied by flow and the specific heat of water
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 13 Apr 2017.
- Individual participant dataSharing planned: No
Related trials for Non-cardiac Surgery
Recruiting
The Effect of Virtual Reality Headsets on Pain, Anxiety, Patient Satisfaction, and Physiological Parameters in Patients Undergoing Open-Heart Surgery
Pain After Surgery, Pain and Anxiety
RecruitingPhase 4
The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery
Pain, Post Operative Analgesia
RecruitingPhase 4
Acetaminophen-Mannitol Injection and Postoperative Delirium
Postoperative Delirium
Not yet recruiting
SPIP vs ESP Block in Cardiac Surgery
Cardiac Surgery, Chronic Postsurgical Pain
RecruitingPhase 4
Can Patients With Atrial Fibrillation Safely Discontinue Anticoagulant Therapy After Cardiac Surgery? (ATLAAC)
Atrial Fibrillation, Left Atrial Appendage Absent
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.
Daniel Sessler, M.D. study chair
Dept Chairman
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophageal Warming and Esophageal Cooling in people with Non-cardiac Surgery, run by The Cleveland Clinic at 1 site in United States.
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 7 inclusion and 3 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 13 Apr 2017. 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 United States. 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?
Mean heat transfer at cooling, kcal/h (time frame: 15-60 minutes after intubation during elective non-cardiac surgery). The study lists 2 primary outcomes in all. 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 13 Apr 2017.