Forced Air Heating to Prevent Hypothermia During Endoscopic Retrograde Cholangiography

NCT ID: NCT05138172

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2024-01-01

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).

Conditions

Temperature Management During Sedation for Endoscopic Retrograde Cholangiography

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Sedation without forced air heating temperature management

Sedation without forced air heating temperature management = present standard in sedation during endoscopic retrograde cholangiography (ERC)

Group Type: PLACEBO_COMPARATOR

Forced Air Heating Temperature control "Twinwarm II"

Intervention Type: 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.

Sedation with forced air heating temperature management

Sedation without forced air heating temperature management = proposed new standard in sedation during endoscopic retrograde cholangiography (ERC)

Group Type: EXPERIMENTAL

Forced Air Heating Temperature control "Twinwarm II"

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hannover Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hannover Medical School

Hanover, Lower Saxony, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Klaus Stahl, PD Dr. med.

Role: CONTACT

stahl.klaus@mh-hannover.de

0049-1532-7841

Henrike Lenzen, PD Dr. med.

Role: CONTACT

lenzen.henrike@mh-hannover.de

0049-1532-6525

Facility Contacts

Klaus Stahl, PD Dr. med.

Role: primary

stahl.klaus@mh-hannover.de

0049-1532-7841

Henrike Lenzen, Pd Dr. med.

Role: backup

lenzen.henrike@mh-hannover.de

0049-1532-6525

Other Identifiers

FAIRHEC

Identifier Type: -

Identifier Source: org_study_id