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

November 17, 2023 updated by: Charles University, Czech Republic
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
      • Praha, Czechia, 16209
        • Recruiting
        • Military University Hospital Prague
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Novotný, M.D.
        • Principal Investigator:
          • Tomáš Tyll, M.D., Ph.D.
        • Principal Investigator:
          • Michal Soták, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Propofol
Patients in whom only propofol will be administered during sedation. Intermittent boluses of propofol titrated to moderate level of sedation.
Drug: Sedation using only Propofol.
Patients in whom only propofol will be administered during sedation.
Other Names:
  • Propofol
Active Comparator: Fentanyl

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.
Drug: Sedation using combination of Propofol and Fentanyl.
Patients in whom combination of propofol and fentanyl will be administered during sedation.
Other Names:
  • Fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of significant decrease in ventilation during propofol sedation.
Time Frame: during the endoscopic procedure
Incidence of significant decrease in ventilation during sedation with propofol alone during endoscopic surgery.
during the endoscopic procedure
Incidence of significant decrease in ventilation during propofol and fentanyl sedation.
Time Frame: during the endoscopic procedure
Incidence of significant decrease in ventilation during sedation with propofol and fentanyl during endoscopic surgery.
during the endoscopic procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective assessment of the comfort of the procedure by the endoscopist.
Time Frame: immediately after the procedure
Subjective assessment of the comfort of the procedure by the endoscopist using a questionnaire.
immediately after the procedure
Subjective assessment of the comfort of the procedure by the patient.
Time Frame: immediately after the procedure
Subjective assessment of the comfort of the procedure by the patient using a questionnaire.
immediately after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Collaborators

Military University Hospital, Prague

Investigators

  • Study Chair: Ilona Trtíková, Mgr., Ph.D., CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND MILITARY UNIVERSITY HOSPITAL PRAGUE
  • Principal Investigator: David Novotný, M.D., CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND MILITARY UNIVERSITY HOSPITAL PRAGUE
  • Principal Investigator: Tomáš Tyll, M.D., Ph.D., CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND MILITARY UNIVERSITY HOSPITAL PRAGUE
  • Principal Investigator: Michal Soták, M.D., Ph.D., CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND MILITARY UNIVERSITY HOSPITAL PRAGUE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 25, 2023

First Submitted That Met QC Criteria

September 25, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Estimated)

November 20, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ExSpironUVN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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