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Optimization of Sedation Protocol for Endoscopic Procedures Using Impedance Ventilation Monitor.

Primary Purpose

Sedation Complication, Ventilatory Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Sedation using only Propofol.
Sedation using combination of Propofol and Fentanyl.
Sponsored by
Charles University, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sedation Complication focused on measuring sedation protocol, endoscopic procedure, ventilation monitoring, ventilatory depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Scheduled therapeutic or diagnostic colonoscopy with sedation Supine or lateral decubitus position Age 18-65 American Society of Anesthesiologists (ASA) physical status classification system 1-2 Informed consent signed Exclusion Criteria: Planned frequent use of electrocoagulation Contact allergy for adhesive pads, excessive thoracic hair or other problem with pads contraindication of using Propofol or Fentanyl Incapability to understand the informed consent

Sites / Locations

  • Military University Hospital Prague

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Propofol

Fentanyl

Arm Description

Patients in whom only propofol will be administered during sedation. Intermittent boluses of propofol titrated to moderate level of sedation.

Patients in whom combination of propofol and fentanyl will be administered during sedation. Fentanyl 1 ug/kg bolus 3 minutes before induction + Propofol intermittent boluses titrated to moderate level of sedation.

Outcomes

Primary Outcome Measures

Incidence of significant decrease in ventilation during propofol sedation.
Incidence of significant decrease in ventilation during sedation with propofol alone during endoscopic surgery.
Incidence of significant decrease in ventilation during propofol and fentanyl sedation.
Incidence of significant decrease in ventilation during sedation with propofol and fentanyl during endoscopic surgery.

Secondary Outcome Measures

Subjective assessment of the comfort of the procedure by the endoscopist.
Subjective assessment of the comfort of the procedure by the endoscopist using a questionnaire.
Subjective assessment of the comfort of the procedure by the patient.
Subjective assessment of the comfort of the procedure by the patient using a questionnaire.

Full Information

First Posted
September 25, 2023
Last Updated
September 29, 2023
Sponsor
Charles University, Czech Republic
Collaborators
Military University Hospital, Prague
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1. Study Identification

Unique Protocol Identification Number
NCT06060626
Brief Title
Optimization of Sedation Protocol for Endoscopic Procedures Using Impedance Ventilation Monitor.
Official Title
Optimization of Sedation Protocol for Endoscopic Procedures Using Impedance Ventilation Monitor.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Charles University, Czech Republic
Collaborators
Military University Hospital, Prague

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 the study is to evaluate the effect of opioids administered during sedation on patients' respiratory activity (ventilation) and comfort of the operator and patient during the endoscopic procedure. A common side effect of sedation is the effect on patients' ventilation, resulting from a combination of attenuation of respiratory centre activity and loss of patent airways. Shallow sedation will reduce these risks, but in addition to patient discomfort, it also increases the difficulty or impossibility of the endoscopist to perform the procedure. Choosing the appropriate method of sedation thus fundamentally affects the course of the procedure from the point of view of both the patient and the endoscopist. The aim is to prove that sedation with propofol alone compared to sedation with propofol and fentanyl premedication leads to the need for higher cumulative doses of administered propofol, higher risk of respiratory depression and lower patient and operator comfort. In addition, the non-invasive respiratory volume monitor (ExSpiron 2Xi) will be used for standard patient monitoring during the procedure, which assesses the lung tidal volume and respiratory rate by measuring the electrical impedance of the chest. This measurement captures inadequate ventilation before saturation drops, allowing even slight differences between selected drugs to be compared.
Detailed Description
The aim of the study is to evaluate the effect of opioids administered during sedation on patients' respiratory activity (ventilation) and comfort of the operator and patient during the endoscopic procedure. A common side effect of sedation is the effect on patients' ventilation, resulting from a combination of attenuation of respiratory centre activity and loss of patent airways. Shallow sedation will reduce these risks, but in addition to patient discomfort, it also increases the difficulty or impossibility of the endoscopist to perform the procedure. Choosing the appropriate method of sedation thus fundamentally affects the course of the procedure from the point of view of both the patient and the endoscopist. The aim is to prove that sedation with propofol alone compared to sedation with propofol and fentanyl premedication leads to the need for higher cumulative doses of administered propofol, higher risk of respiratory depression and lower patient and operator comfort. Standard monitoring during endoscopic procedures using sedation includes continual recording of ECG and respiratory rate (using the same electrodes), measurement of arterial blood oxygen saturation using a pulse oximeter and blood pressure measurement. Extended monitoring of spontaneous ventilation during sedation includes analysis of the concentration of exhaled carbon dioxide or analysis of the arterial blood gases.However, these methods have limitations and often critically reduced respiratory activity is diagnosed too late. Impedance monitoring of ventilation is now being introduced into clinical practice. In addition, the non-invasive respiratory volume monitor (ExSpiron 2Xi) will be used for standard patient monitoring during the procedure, which assesses the lung tidal volume and respiratory rate by measuring the electrical impedance of the chest. This measurement captures inadequate ventilation before saturation drops, allowing even slight differences between selected drugs to be compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedation Complication, Ventilatory Depression
Keywords
sedation protocol, endoscopic procedure, ventilation monitoring, ventilatory depression

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will be performed on a sample of patients undergoing an endoscopic procedure requiring sedation. Patients will be divided into two groups, one group will be sedated with propofol only, the other will be premedicated with the opioid analgesic fentanyl before the procedure.
Masking
Care Provider
Masking Description
The endoscopist performing the procedure will not be informed which group the patient belongs to.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
Patients in whom only propofol will be administered during sedation. Intermittent boluses of propofol titrated to moderate level of sedation.
Arm Title
Fentanyl
Arm Type
Active Comparator
Arm Description
Patients in whom combination of propofol and fentanyl will be administered during sedation. Fentanyl 1 ug/kg bolus 3 minutes before induction + Propofol intermittent boluses titrated to moderate level of sedation.
Intervention Type
Drug
Intervention Name(s)
Sedation using only Propofol.
Other Intervention Name(s)
Propofol
Intervention Description
Patients in whom only propofol will be administered during sedation.
Intervention Type
Drug
Intervention Name(s)
Sedation using combination of Propofol and Fentanyl.
Other Intervention Name(s)
Fentanyl
Intervention Description
Patients in whom combination of propofol and fentanyl will be administered during sedation.
Primary Outcome Measure Information:
Title
Incidence of significant decrease in ventilation during propofol sedation.
Description
Incidence of significant decrease in ventilation during sedation with propofol alone during endoscopic surgery.
Time Frame
during the endoscopic procedure
Title
Incidence of significant decrease in ventilation during propofol and fentanyl sedation.
Description
Incidence of significant decrease in ventilation during sedation with propofol and fentanyl during endoscopic surgery.
Time Frame
during the endoscopic procedure
Secondary Outcome Measure Information:
Title
Subjective assessment of the comfort of the procedure by the endoscopist.
Description
Subjective assessment of the comfort of the procedure by the endoscopist using a questionnaire.
Time Frame
immediately after the procedure
Title
Subjective assessment of the comfort of the procedure by the patient.
Description
Subjective assessment of the comfort of the procedure by the patient using a questionnaire.
Time Frame
immediately after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Scheduled therapeutic or diagnostic colonoscopy with sedation Supine or lateral decubitus position Age 18-65 American Society of Anesthesiologists (ASA) physical status classification system 1-2 Informed consent signed Exclusion Criteria: Planned frequent use of electrocoagulation Contact allergy for adhesive pads, excessive thoracic hair or other problem with pads contraindication of using Propofol or Fentanyl Incapability to understand the informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilona Trtíková, Mgr., Ph.D.
Phone
+420224965613
Email
ilona.trtikova@clf1.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Michal Soták, M.D., PhD.
Phone
+4209732999
Email
michal.sotak@uvn.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilona Trtíková, Mgr., Ph.D.
Organizational Affiliation
CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND MILITARY UNIVERSITY HOSPITAL PRAGUE
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David Novotný, M.D.
Organizational Affiliation
CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND MILITARY UNIVERSITY HOSPITAL PRAGUE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tomáš Tyll, M.D., Ph.D.
Organizational Affiliation
CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND MILITARY UNIVERSITY HOSPITAL PRAGUE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michal Soták, M.D., Ph.D.
Organizational Affiliation
CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND MILITARY UNIVERSITY HOSPITAL PRAGUE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Military University Hospital Prague
City
Praha
ZIP/Postal Code
16209
Country
Czechia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michal Soták, M.D., Ph.D.
Phone
+420973202999
Email
michal.sotak@uvn.cz
First Name & Middle Initial & Last Name & Degree
David Novotný, M.D.
Phone
+420973202999
Email
novotny.david@uvn.cz
First Name & Middle Initial & Last Name & Degree
David Novotný, M.D.
First Name & Middle Initial & Last Name & Degree
Tomáš Tyll, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Michal Soták, M.D., Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31313720
Citation
Bai Y, Xu Z, Chandrashekar M, St Jacques PJ, Liang Y, Jiang Y, Kla K. Comparison of a simplified nasal continuous positive airways pressure device with nasal cannula in obese patients undergoing colonoscopy during deep sedation: A randomised clinical trial. Eur J Anaesthesiol. 2019 Sep;36(9):633-640. doi: 10.1097/EJA.0000000000001052.
Results Reference
background
PubMed Identifier
28337439
Citation
Zhang X, Kassem MA, Zhou Y, Shabsigh M, Wang Q, Xu X. A Brief Review of Non-invasive Monitoring of Respiratory Condition for Extubated Patients with or at Risk for Obstructive Sleep Apnea after Surgery. Front Med (Lausanne). 2017 Mar 8;4:26. doi: 10.3389/fmed.2017.00026. eCollection 2017.
Results Reference
result
PubMed Identifier
25037938
Citation
Voscopoulos CJ, MacNabb CM, Brayanov J, Qin L, Freeman J, Mullen GJ, Ladd D, George E. The evaluation of a non-invasive respiratory volume monitor in surgical patients undergoing elective surgery with general anesthesia. J Clin Monit Comput. 2015 Apr;29(2):223-30. doi: 10.1007/s10877-014-9596-0. Epub 2014 Jul 19.
Results Reference
result

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Optimization of Sedation Protocol for Endoscopic Procedures Using Impedance Ventilation Monitor.

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