Temperature Management During Sedation for Endoscopic Retrograde CholangiographyFAIRHECNCT05138172
Forced Air Heating to Prevent Hypothermia During Endoscopic Retrograde Cholangiography
A study of Temperature Management During Sedation for Endoscopic Retrograde Cholangiography, run by Hannover Medical School at 1 site in Germany.
Trial summary
The aim of this prospective observational study is to evaluate the role of a convective warming blanket to prevent hypothermia during sedation for an endoscopic retrograde cholangiography (ERC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temperature Management During Sedation for Endoscopic Retrograde Cholangiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2021to 1 Jan 2024
- 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
- Indication to receive repeat (≥ 2 expected interventions) endoscopic retrograde cholangiography (ERC) (The following underlying conditions may be considered as indications for repeat ERC to be performed:
- Primary sclerosing cholangitis (PSC)
- Ischemic type biliary lesion (ITBL) after liver transplantation (LTX)
- Anastomotic stenosis after LTX
- Secondary sclerosing cholangitis (SSC))
- necessary intravenous medical sedation is expected to be required >30min (female and male, age ≥ 18 years).
Who cannot join
- Patients < 18 years
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Hannover Medical School
Hanover, Lower Saxony, 30625
Klaus Stahl, PD Dr. med., 0049-1532-7841, stahl.klaus@mh-hannover.de
Henrike Lenzen, Pd Dr. med., 0049-1532-6525, lenzen.henrike@mh-hannover.de
About this study
The aim of this prospective observational study is to evaluate the role of a convective warming blanket to prevent hypothermia during sedation for an endoscopic retrograde cholangiography (ERC).
Read the detailed description
During endoscopic retrograde cholangiography (ERC), deep medical sedation of the patient is routinely perform. Since ERC is a complex examination and in addition sometimes several intervention steps are necessary (bougienage, dilatation, brush cytology, specimen collection, insertion of plastic and metal stent prostheses), the sedation time is almost always > 30min, in many cases even up to one hour or longer. These patients are at risk for developing hypothermia (drop in core body temperature below 36 degrees Celsius).
It is well known from anesthesiologic research that even moderate perioperative hypothermia, however, can have potentially serious complications. These include increased mortality, cardiac complications such as arrhythmias and infarctions, coagulation disorders, and increased transfusion requirements and wound infections. Changes in serum concentrations of potassium and peripheral vasoconstriction with decrease in subcutaneous partial pressure of oxygen are also clinically important side effects of perioperative hypothermia.
However, the current 2014 German S3 guideline "Sedation in gastrointestinal endoscopy" does not mention peri- or intra-interventional temperature measurement or temperature management.
The aim of this prospective observational study is to evaluate the role of a convective warming blanket to prevent hypothermia during sedation for an ERC. From the description of various clinical endpoints, we seek to obtain sufficient evidence to support routine use of such a system in ERC examinations. This study has the potential to set the new standard for modern sedation during ERC interventions that recognizes the risk of hypothermia and identifies a strategy to avoid it.
For this purpose, we will use a device, that is already routinely used in all operation rooms in Germany, the so-called warm air device "Twinwarm, Generation III". This device has a valid CE mark and will be used according to its purpose "pre-, intra- and postoperative maintenance of the normothermic body temperature of the patient". The device will be used strictly in accordance with the existing in-house SOP "Heat Management" of 04/2021 of the Department of Anesthesiology and Intensive Care Medicine of Hannover Medical School (MHH).
- Being tested
- Forced Air Heating Temperature control "Twinwarm II"
- Keywords
- sedation, endoscopic retrograde cholangiography, temperature managment, hypothermia
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forced Air Heating Temperature control "Twinwarm II"Device
For this purpose, we will use a device that is already routinely used in all operation rommss at MHH, the so-called "warm air device Twinwarm, Generation III". This device has a valid CE mark and will be used according to its purpose "pre-, intra- and postoperative maintenance of the normothermic body temperature of the patient". The device will be used strictly according to the existing in-house SOP "Heat Management" of 04/2021 of the Department of Anesthesiology and Intensive Care Medicine of the MHH.
Convective air heating has been shown to be effective in many studies and can be used flexibly with a variety of different ceiling models.
| Study group | Role | What they receive |
|---|---|---|
| Sedation without forced air heating temperature management | Placebo comparator | Sedation without forced air heating temperature management = present standard in sedation during endoscopic retrograde cholangiography (ERC) Receives: Device: Forced Air Heating Temperature control "Twinwarm II" |
| Sedation with forced air heating temperature management | Experimental | Sedation without forced air heating temperature management = proposed new standard in sedation during endoscopic retrograde cholangiography (ERC) Receives: Device: Forced Air Heating Temperature control "Twinwarm II" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Highest absolute change of T from baseline at any time during intervention as well as at the end of intervention
Primary Endpoint
Measured: During Intervention
Secondary outcomes (5)
Percentage of patients with a reduction of T from baseline more than 1 degree Celsius at any time during intervention as well as at the end of intervention
Key Secondary Endpoint
Measured: During Intervention
Percentage of patients with a reduction of T below 36 degree Celsius at any time during intervention as well as at the end of intervention
Percentage of patients with a reduction of T below 36 degree Celsius
Measured: During Intervention
Hemodynamic stability
Mean arterial pressure (MAP)
- Lowest absolute MAP (mmHg)
- Percentage of patients with a reduction of MAP of at least 25% from baseline
- Absolute change of MAP below 65mmHg from baseline
Heart Rate:
- Relative difference: Percentage of patients with an increase of HR of at least 25% from baseline
- Percentage of patients with a increase of heart rate > 100bpm
Intravenous fluids:
- Percentage of patients (%) needing intravenous fluid support for hemodynamic stability
- Cumulative total Volume (ml) of intravenous fluid support
Vasoactive substances:
- Percentage of patients (%) needing vasoactive substance support
Measured: During Intervention
Respiratory Stability
peripheral Oxygen Saturation (O2-Sat)
- Percentage of patients with a reduction of O2-Sat below 90%
Oxygen support:
- Percentage of patients needing > 2l/min oxygen
- Maximum needed flow (l/min) of oxygen delivery
Further adverse events:
- Percentage of patients (%) needing mask ventilation
- Percentage of patients (%) with need for Guedel or Wendel tube insertion
Measured: During Intervention
Subjective Patient Satisfaction
Subjective Freezing (VAS 0-10 points, with higher scores indicating more intense freezing)
Quality of Recovery (QoR) Score by Myles et al. (Use of the German Modifikation by Eberhart et al) with score ranging from 0 to 18 points and higher scores indicating more discomfort with anesthesia
modified DGAI Score with score ranging from 0 to 9 points and higher scores indicating more discomfort with anesthesia
Measured: 6 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start1 Dec 2021
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temperature Management During Sedation for Endoscopic Retrograde CholangiographyStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138172
- Sponsor's protocol ID
- FAIRHEC
- Acronym
- FAIRHEC
- Status last verified
- May 2023
- First submitted
- 8 Nov 2021
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forced Air Heating to Prevent Hypothermia During Endoscopic Retrograde Cholangiography
- ClinicalTrials.gov ID
- NCT05138172
- Acronym / sponsor ID
- FAIRHEC / FAIRHEC
- Keywords
- sedation, endoscopic retrograde cholangiography, temperature managment, hypothermia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 30 Nov 2021 (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.
The aim of this prospective observational study is to evaluate the role of a convective warming blanket to prevent hypothermia during sedation for an endoscopic retrograde cholangiography (ERC).
Detailed description
During endoscopic retrograde cholangiography (ERC), deep medical sedation of the patient is routinely perform. Since ERC is a complex examination and in addition sometimes several intervention steps are necessary (bougienage, dilatation, brush cytology, specimen collection, insertion of plastic and metal stent prostheses), the sedation time is almost always > 30min, in many cases even up to one hour or longer. These patients are at risk for developing hypothermia (drop in core body temperature below 36 degrees Celsius).
It is well known from anesthesiologic research that even moderate perioperative hypothermia, however, can have potentially serious complications. These include increased mortality, cardiac complications such as arrhythmias and infarctions, coagulation disorders, and increased transfusion requirements and wound infections. Changes in serum concentrations of potassium and peripheral vasoconstriction with decrease in subcutaneous partial pressure of oxygen are also clinically important side effects of perioperative hypothermia.
However, the current 2014 German S3 guideline "Sedation in gastrointestinal endoscopy" does not mention peri- or intra-interventional temperature measurement or temperature management.
The aim of this prospective observational study is to evaluate the role of a convective warming blanket to prevent hypothermia during sedation for an ERC. From the description of various clinical endpoints, we seek to obtain sufficient evidence to support routine use of such a system in ERC examinations. This study has the potential to set the new standard for modern sedation during ERC interventions that recognizes the risk of hypothermia and identifies a strategy to avoid it.
For this purpose, we will use a device, that is already routinely used in all operation rooms in Germany, the so-called warm air device "Twinwarm, Generation III". This device has a valid CE mark and will be used according to its purpose "pre-, intra- and postoperative maintenance of the normothermic body temperature of the patient". The device will be used strictly in accordance with the existing in-house SOP "Heat Management" of 04/2021 of the Department of Anesthesiology and Intensive Care Medicine of Hannover Medical School (MHH).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedation without forced air heating temperature management | Placebo comparator | Device: Forced Air Heating Temperature control "Twinwarm II"Sedation without forced air heating temperature management = present standard in sedation during endoscopic retrograde cholangiography (ERC) |
| Sedation with forced air heating temperature management | Experimental | Device: Forced Air Heating Temperature control "Twinwarm II"Sedation without forced air heating temperature management = proposed new standard in sedation during endoscopic retrograde cholangiography (ERC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Indication to receive repeat (≥ 2 expected interventions) endoscopic retrograde cholangiography (ERC) (The following underlying conditions may be considered as indications for repeat ERC to be performed:
- Primary sclerosing cholangitis (PSC)
- Ischemic type biliary lesion (ITBL) after liver transplantation (LTX)
- Anastomotic stenosis after LTX
- Secondary sclerosing cholangitis (SSC))
Key exclusion criteria (2 listed)
- Patients < 18 years
- Pregnant women
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 |
|---|---|---|
| Forced Air Heating Temperature control "Twinwarm II"For this purpose, we will use a device that is already routinely used in all operation rommss at MHH, the so-called "warm air device Twinwarm, Generation III". This device has a valid CE mark and will be used according to its purpose "pre-, intra- and postoperative maintenance of the normothermic body temperature of the patient". The device will be used strictly according to the existing in-house SOP "Heat Management" of 04/2021 of the Department of Anesthesiology and Intensive Care Medicine of the MHH. Convective air heating has been shown to be effective in many studies and can be used flexibly with a variety of different ceiling models. | Device | Sedation with forced air heating temperature management, Sedation without forced air heating temperature management |
Primary outcome
Highest absolute change of T from baseline at any time during intervention as well as at the end of intervention
Time frame: During Intervention
Primary Endpoint
5 secondary outcomes
Percentage of patients with a reduction of T from baseline more than 1 degree Celsius at any time during intervention as well as at the end of intervention
Time frame: During Intervention
Percentage of patients with a reduction of T below 36 degree Celsius at any time during intervention as well as at the end of intervention
Time frame: During Intervention
Hemodynamic stability
Time frame: During Intervention
Respiratory Stability
Time frame: During Intervention
Subjective Patient Satisfaction
Time frame: 6 hours after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Individual participant dataSharing planned: Undecided. IPD will be shared on reasonable request.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Temperature Management During Sedation for Endoscopic Retrograde Cholangiography, run by Hannover Medical School at 1 site in Germany.
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 6 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: status not confirmed, as of the sponsor's last update on 25 May 2023. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Klaus Stahl, PD Dr. med. (0049-1532-7841, stahl.klaus@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Highest absolute change of T from baseline at any time during intervention as well as at the end of intervention (time frame: During Intervention). 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 25 May 2023.