Forced Air Heating to Prevent Hypothermia During Endoscopic Retrograde Cholangiography (FAIRHEC)
Primary Purpose
Temperature Management During Sedation for Endoscopic Retrograde Cholangiography
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Forced Air Heating Temperature control "Twinwarm II"
Sponsored by
About this trial
This is an interventional prevention trial for Temperature Management During Sedation for Endoscopic Retrograde Cholangiography focused on measuring sedation, endoscopic retrograde cholangiography, temperature managment, hypothermia
Eligibility Criteria
Inclusion criteria:
- 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).
Exclusion Criteria:
- Patients < 18 years
- Pregnant women
Sites / Locations
- Hannover Medical SchoolRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Sedation without forced air heating temperature management
Sedation with forced air heating temperature management
Arm Description
Sedation without forced air heating temperature management = present standard in sedation during endoscopic retrograde cholangiography (ERC)
Sedation without forced air heating temperature management = proposed new standard in sedation during endoscopic retrograde cholangiography (ERC)
Outcomes
Primary Outcome Measures
Highest absolute change of T from baseline at any time during intervention as well as at the end of intervention
Primary Endpoint
Secondary Outcome Measures
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
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05138172
Brief Title
Forced Air Heating to Prevent Hypothermia During Endoscopic Retrograde Cholangiography
Acronym
FAIRHEC
Official Title
Forced Air Heating to Prevent Hypothermia During Endoscopic Retrograde Cholangiography
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hannover Medical School
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temperature Management During Sedation for Endoscopic Retrograde Cholangiography
Keywords
sedation, endoscopic retrograde cholangiography, temperature managment, hypothermia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sedation without forced air heating temperature management
Arm Type
Placebo Comparator
Arm Description
Sedation without forced air heating temperature management = present standard in sedation during endoscopic retrograde cholangiography (ERC)
Arm Title
Sedation with forced air heating temperature management
Arm Type
Experimental
Arm Description
Sedation without forced air heating temperature management = proposed new standard in sedation during endoscopic retrograde cholangiography (ERC)
Intervention Type
Device
Intervention Name(s)
Forced Air Heating Temperature control "Twinwarm II"
Intervention Description
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.
Primary Outcome Measure Information:
Title
Highest absolute change of T from baseline at any time during intervention as well as at the end of intervention
Description
Primary Endpoint
Time Frame
During Intervention
Secondary Outcome Measure Information:
Title
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
Description
Key Secondary Endpoint
Time Frame
During Intervention
Title
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
Description
Percentage of patients with a reduction of T below 36 degree Celsius
Time Frame
During Intervention
Title
Hemodynamic stability
Description
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
Time Frame
During Intervention
Title
Respiratory Stability
Description
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
Time Frame
During Intervention
Title
Subjective Patient Satisfaction
Description
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
Time Frame
6 hours after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
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).
Exclusion Criteria:
Patients < 18 years
Pregnant women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Klaus Stahl, PD Dr. med.
Phone
0049-1532-7841
Email
stahl.klaus@mh-hannover.de
First Name & Middle Initial & Last Name or Official Title & Degree
Henrike Lenzen, PD Dr. med.
Phone
0049-1532-6525
Email
lenzen.henrike@mh-hannover.de
Facility Information:
Facility Name
Hannover Medical School
City
Hannover
State/Province
Lower Saxony
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Klaus Stahl, PD Dr. med.
Phone
0049-1532-7841
Email
stahl.klaus@mh-hannover.de
First Name & Middle Initial & Last Name & Degree
Henrike Lenzen, Pd Dr. med.
Phone
0049-1532-6525
Email
lenzen.henrike@mh-hannover.de
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
IPD will be shared on reasonable request.
Learn more about this trial
Forced Air Heating to Prevent Hypothermia During Endoscopic Retrograde Cholangiography
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