Anoxic Brain InjuryE-ChillNCT02387775
Temperature Control With an Esophageal Cooling Device in Post Cardiac Arrest Patients
A study of Anoxic Brain Injury and Cardiac Arrest, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.
Trial summary
This is a prospective, interventional study aiming to assess the effectiveness of the Esophageal Cooling Device (ECD) as a temperature control modality in post cardiac arrest patients. In addition, observed adverse events during ECD use, ease-of-use, nurse satisfaction and patient outcomes will be examined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anoxic Brain Injury, Cardiac Arrest
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesCanada
- Study dates
- Dec 2015to 15 Jun 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to the intensive care unit after resuscitation from an out-of-hospital cardiac arrest.
- Sustained return of spontaneous circulation (no chest compressions required for >20 minutes)
- Not obeying commands to verbal instruction.
- On mechanical ventilation via endotracheal tube or tracheotomy.
Who cannot join
- Known esophageal deformity (known esophageal varices, history of esophagectomy, previous swallowing disorders, achalasia, etc.) or evidence of esophageal trauma.
- Known ingestion of acidic or caustic poisons within the prior 24 hours.
- Patients with less than 40 kg of body mass.
- Patients known to be pregnant.
- Uncontrolled coagulopathy.
- Documented intracranial hemorrhage.
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- Patients presenting to the intensive care unit with a temperature < 35°C.
- Time from collapse to return of spontaneous circulation > 45 minutes or unknown.
- Time from collapse to starting chest compressions > 10 minutes or unknown.
- Time from collapse to assessment for enrollment > 12 hours.
- Patients thought to have a very low chance of surviving the next 48 hours as assessed by the research team.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University Hospital, London Health Sciences Centre, University of Western Ontario
London, Ontario, N6A 5A5
Victoria Hospital, London Health Sciences Centre, University of Western Ontario
London, Ontario, N6A 5W9
About this study
Official title: Temperature Control With an Esophageal Cooling Device: A Feasibility Study in Post Cardiac Arrest Patients
This is a prospective, interventional study aiming to assess the effectiveness of the Esophageal Cooling Device (ECD) as a temperature control modality in post cardiac arrest patients. In addition, observed adverse events during ECD use, ease-of-use, nurse satisfaction and patient outcomes will be examined.
Read the detailed description
Temperature control in comatose survivors of cardiac arrest, is a critical aspect of these patients' care. In this context, mild temperature reduction for 24 hours post cardiac arrest has been shown to improve neurological outcomes.
Hypothermia is commonly induced using a combination of internal and external cooling modalities. Internal cooling modalities include intravenous administration of cold crystalloids and intravascular cooling catheters. External or body surface cooling can be achieved using cooling blankets, adhesive pads, and ice packs. Each of these methods however, has its limitations.
Administration of intravenous refrigerated crystalloid (4°C) boluses is a simple, effective and widely available method of hypothermia induction. Lack of precise temperature control and the potential for pulmonary edema however, make this modality unsuitable for the maintenance phase of hypothermia. Surface cooling methods, such as cooling blankets and ice packs, often cause shivering, skin breakdown, and in obese patients may be ineffective. Intravascular cooling catheters require the time of a physician for insertion and bear the potential risks of line infection and deep venous thrombosis. Searching for a temperature control device that overcomes the limitations, inefficiencies and inconveniences of existing modalities is therefore strongly desired.
The ideal temperature control modality should be effective, predictable and easy to use. An esophageal cooling device has recently become available which in theory may, may possess some of these attributes. To date, there have been no published studies examining this device's efficacy. In addition, no study has documented any adverse events during it's use, or evaluated it's ease-of-use at the bedside.
This is a prospective, interventional study aiming to assess the effectiveness of the Esophageal Cooling Device (ECD) as a temperature control modality in comatose survivors of cardiac arrest (the E-Chill trial). In addition, observed adverse events during ECD use, ease-of-use, nurse satisfaction and patient outcomes will be examined.
- Conditions
- Anoxic Brain Injury, Cardiac Arrest
- Being tested
- Esophageal temperature control
- Keywords
- esophageal cooling device, post cardiac arrest, targetted temperature management, therapeutic hypothermia, cooling, rewarming
- Medical subject headings
- Hypoxia-Ischemia, Brain, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal temperature controlDevice
Also called Esophageal Cooling Device®
Insertion of the Esophageal Cooling Device (ECD) will take place as described in the product monograph. The ECD will be connected to the heat exchange unit Blanketrol Hyper-Hypothermia System® (Cincinnati Sub-Zero, Cincinnati, OH) and will be used for temperature control for a total of 36 hours. A patient target of 35°C will be set on the heat exchange unit. Once target is attained, it will be maintained for 24 hours. Slow rewarming will then be achieved by increasing the input target by 0.2°C per hour, until a target of 36.6°C is reached.
All temperature data (device, input target, and patient bladder temperature) will be captured automatically using Data Export Software® (Cincinnati Sub-Zero, Cincinnati, OH) on an external laptop connected to the external heat exchange unit.
| Study group | Role | What they receive |
|---|---|---|
| Esophageal temperature control | Experimental | The Esophageal Cooling Device (ECD) will be inserted and utilized for temperature control for up to 36 hours in this arm. The ECD will be used for all three phases of therapeutic hypothermia; induction, maintenance, and rewarming. Conventional cooling or warming techniques (e.g. cold saline, ice packs, cooling or warming blankets) will still be made available to the treating ICU team to be used at their discretion. Receives: Device: Esophageal temperature control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of time maintained within 0.5°C range of the 35°C input target, in the hypothermia maintenance phase.
Once patient temperature is within 0.5°C from the 35°C target, the maintenance phase will commence. The amount of time patient temperature is maintained within ± 0.5 from 35°C, as a percentage of the total hypothermia maintenance time (24 hours) will be examined. Confidence intervals for the results will be reported.
Measured: Within 36 hours of ECD insertion.
Secondary outcomes (7)
Cooling rate in hypothermia induction phase.
Average rate of temperature drop during the hypothermia induction phase. The induction phase ends once the patient temperature is within ± 0.5 from the 35°C target. Confidence intervals for the results will be reported.
Measured: Within 10 hours of ECD insertion.
Percent of time patient temperature is within 0.5°C range of the input target, 30 minutes after each target elevation in the rewarming phase.
Rewarming time will be considered to start, 30 minutes after the input target is increased from 35 to 35.2°C. Since patient temperature is likely to change slowly after that change, the recorded temperature taken 30 minutes after the target change will be used. Therefore if the target temperature is changed to 35.2°C at noon, the patient temperature recorded at 12:30 will be used. Whether or not the patient is within ± 0.5 from the 35.2°C target will be calculated using the patient temperatures recorded at 12:30 till the next change in target temperature. And for each subsequent elevation in target, this same rule will be applied. This calculation will be taken to reflect the degree of control over rewarming. Confidence intervals for the results will be reported.
Measured: Within 36 hours of ECD insertion.
ECD insertion time.
Time taken to insert the Esophageal Cooling Device (ECD) will be measured. This will only include time needed to insert the ECD orally and advance it to the appropriate depth. This will exclude the steps prior to insertion (measuring the appropriate depth of insertion externally, connecting the ECD to the external heat exchange unit, and lubing the tip of the ECD). Taping the ECD in place will be excluded from this time recording as well.
Measured: Within 4 hours of enrollment.
Adverse events during and after ECD use.
Recorded events during or after ECD use: cardiac arrhythmias, bradycardias, myocardial infarction/re-infarction, ventilator associated pneumonia, gastrointestinal bleeding (any), esophageal injury, dysphagia, odynophagia, aspiration pneumonia, non-aspiration pneumonia, tube feed intolerance, reflux and evidence of esophagitis.
Measured: Within 4 weeks of enrollment or until hospital discharge whichever comes first.
Ease-of-use.
Nurses taking care of patients with the device will be asked to rate the following:
- Observed ease of insertion of device 1 = poor, 3 = average, 5 = excellent. II. General ease-of-use and handling: 1 = poor, 3 = average, 5 = excellent. III. How the ECD compares to our standard methods of inducing hypothermia: 1 = inferior, 3 = equivalent, 5 = superior.
IV. Since ECD insertion, have any other cooling modality been used to cool or warm the patient? If yes, please specify.
Measured: Within 40 hours of enrollment.
Patient neurological outcome as defined by the Cerebral Performance Category.
Patient neurological outcome will be dichotomized into good or bad. Good outcome will be equivalent to CPC scores of 1 \& 2 (where the patient is independent), and bad outcome will be equivalent to CPC scores of 3, 4 \& 5 (where the patient is either dependent or dead).
CPC Scale:
- Functioning normally and independent, possibly with a minor disability.
- Moderately disabled, still independent.
- Conscious but with a severe disability, dependent.
- Unconscious (comatose or in a persistent vegetative state).
- Brain dead or dead by traditional criteria.
Measured: Within 4 weeks of enrollement or until hospital discharge whichever comes earlier.
Need for other cooling or warming modalities during ECD use.
The requirement for any of the following cooling modalities during ECD use will be documented.
- Intravenous refrigerated saline. Data collected: times of use, volumes administered, and reasons for use as per bedside nurse.
- Cooling or warming blanket use. Data collected: times of use, duration of application, and reason for use as per bedside nurse.
- Ice-pack application. Data collected: time of use, body location(s) applied, duration of application, and reason for application as per bedside nurse.
- Body cavity cold fluid irrigation e.g. bladder, peritoneal... etc. Data collected: time of use, body cavity site, reason for use as per bedside nurse.
Measured: Within 36 hours of ECD insertion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startDec 2015
- Primary completionJun 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anoxic Brain InjuryStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Western University, Canada
- Responsible party
- Sponsor
- Investigators
- Ahmed F. Hegazy, MBBCh, FRCPC, Principal investigator, Western Univeristy, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387775
- Sponsor's protocol ID
- 106185
- Acronym
- E-Chill
- Status last verified
- May 2018
- First submitted
- 9 Mar 2015
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Hegazy AF, Lapierre DM, Butler R, Althenayan E. Temperature control in critically ill patients with a novel esophageal cooling device: a case series. BMC Anesthesiol. 2015 Oct 19;15:152. doi: 10.1186/s12871-015-0133-6.
PubMed 26481105
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temperature Control With an Esophageal Cooling Device: A Feasibility Study in Post Cardiac Arrest Patients
- ClinicalTrials.gov ID
- NCT02387775
- Acronym / sponsor ID
- E-Chill / 106185
- Conditions
- Anoxic Brain Injury, Cardiac Arrest
- Keywords
- esophageal cooling device, post cardiac arrest, targetted temperature management, therapeutic hypothermia, cooling, rewarming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Western University, Canada
- Study start
- Dec 2015
- Primary completion
- Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 13 Mar 2015 (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.
This is a prospective, interventional study aiming to assess the effectiveness of the Esophageal Cooling Device (ECD) as a temperature control modality in post cardiac arrest patients. In addition, observed adverse events during ECD use, ease-of-use, nurse satisfaction and patient outcomes will be examined.
Detailed description
Temperature control in comatose survivors of cardiac arrest, is a critical aspect of these patients' care. In this context, mild temperature reduction for 24 hours post cardiac arrest has been shown to improve neurological outcomes.
Hypothermia is commonly induced using a combination of internal and external cooling modalities. Internal cooling modalities include intravenous administration of cold crystalloids and intravascular cooling catheters. External or body surface cooling can be achieved using cooling blankets, adhesive pads, and ice packs. Each of these methods however, has its limitations.
Administration of intravenous refrigerated crystalloid (4°C) boluses is a simple, effective and widely available method of hypothermia induction. Lack of precise temperature control and the potential for pulmonary edema however, make this modality unsuitable for the maintenance phase of hypothermia. Surface cooling methods, such as cooling blankets and ice packs, often cause shivering, skin breakdown, and in obese patients may be ineffective. Intravascular cooling catheters require the time of a physician for insertion and bear the potential risks of line infection and deep venous thrombosis. Searching for a temperature control device that overcomes the limitations, inefficiencies and inconveniences of existing modalities is therefore strongly desired.
The ideal temperature control modality should be effective, predictable and easy to use. An esophageal cooling device has recently become available which in theory may, may possess some of these attributes. To date, there have been no published studies examining this device's efficacy. In addition, no study has documented any adverse events during it's use, or evaluated it's ease-of-use at the bedside.
This is a prospective, interventional study aiming to assess the effectiveness of the Esophageal Cooling Device (ECD) as a temperature control modality in comatose survivors of cardiac arrest (the E-Chill trial). In addition, observed adverse events during ECD use, ease-of-use, nurse satisfaction and patient outcomes will be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Esophageal temperature control | Experimental | Device: Esophageal temperature controlThe Esophageal Cooling Device (ECD) will be inserted and utilized for temperature control for up to 36 hours in this arm. The ECD will be used for all three phases of therapeutic hypothermia; induction, maintenance, and rewarming. Conventional cooling or warming techniques (e.g. cold saline, ice packs, cooling or warming blankets) will still be made available to the treating ICU team to be used at their discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients admitted to the intensive care unit after resuscitation from an out-of-hospital cardiac arrest.
- Sustained return of spontaneous circulation (no chest compressions required for >20 minutes)
- Not obeying commands to verbal instruction.
- On mechanical ventilation via endotracheal tube or tracheotomy.
Key exclusion criteria (11 listed)
- Known esophageal deformity (known esophageal varices, history of esophagectomy, previous swallowing disorders, achalasia, etc.) or evidence of esophageal trauma.
- Known ingestion of acidic or caustic poisons within the prior 24 hours.
- Patients with less than 40 kg of body mass.
- Patients known to be pregnant.
- Uncontrolled coagulopathy.
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 temperature controlAlso: Esophageal Cooling Device®Insertion of the Esophageal Cooling Device (ECD) will take place as described in the product monograph. The ECD will be connected to the heat exchange unit Blanketrol Hyper-Hypothermia System® (Cincinnati Sub-Zero, Cincinnati, OH) and will be used for temperature control for a total of 36 hours. A patient target of 35°C will be set on the heat exchange unit. Once target is attained, it will be maintained for 24 hours. Slow rewarming will then be achieved by increasing the input target by 0.2°C per hour, until a target of 36.6°C is reached. All temperature data (device, input target, and patient bladder temperature) will be captured automatically using Data Export Software® (Cincinnati Sub-Zero, Cincinnati, OH) on an external laptop connected to the external heat exchange unit. | Device | Esophageal temperature control |
Primary outcome
Percent of time maintained within 0.5°C range of the 35°C input target, in the hypothermia maintenance phase.
Time frame: Within 36 hours of ECD insertion.
Once patient temperature is within 0.5°C from the 35°C target, the maintenance phase will commence. The amount of time patient temperature is maintained within ± 0.5 from 35°C, as a percentage of the total hypothermia maintenance time (24 hours) will be examined. Confidence intervals for the results will be reported.
7 secondary outcomes
Cooling rate in hypothermia induction phase.
Time frame: Within 10 hours of ECD insertion.
Percent of time patient temperature is within 0.5°C range of the input target, 30 minutes after each target elevation in the rewarming phase.
Time frame: Within 36 hours of ECD insertion.
ECD insertion time.
Time frame: Within 4 hours of enrollment.
Adverse events during and after ECD use.
Time frame: Within 4 weeks of enrollment or until hospital discharge whichever comes first.
Ease-of-use.
Time frame: Within 40 hours of enrollment.
Patient neurological outcome as defined by the Cerebral Performance Category.
Time frame: Within 4 weeks of enrollement or until hospital discharge whichever comes earlier.
Need for other cooling or warming modalities during ECD use.
Time frame: Within 36 hours of ECD insertion.
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 30 Jul 2018.
- Background: PubMed 26481105Hegazy AF, Lapierre DM, Butler R, Althenayan E. Temperature control in critically ill patients with a novel esophageal cooling device: a case series. BMC Anesthesiol. 2015 Oct 19;15:152. doi: 10.1186/s12871-015-0133-6.
- The esophageal cooling device insertion steps, the heat exchange unit set-up, our local practice at London Health Sciences Centre, and some general recommendations on the device's use.Link provided by the sponsor.
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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.
Ahmed F. Hegazy, MBBCh, FRCPC principal investigator
Western Univeristy, Canada
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Anoxic Brain Injury and Cardiac Arrest, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.
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 4 inclusion and 11 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 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Percent of time maintained within 0.5°C range of the 35°C input target, in the hypothermia maintenance phase. (time frame: Within 36 hours of ECD insertion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02387775, which also lists 1 linked publication.
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 30 Jul 2018.