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

NCT ID: NCT06060626

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-16
• Study Completion Date: 2025-01-22

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.

Conditions

Sedation Complication; Ventilatory Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Propofol

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

Group Type: ACTIVE_COMPARATOR

Sedation using only Propofol.

Intervention Type: DRUG

Patients in whom only propofol will be administered during sedation.

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.

Group Type: ACTIVE_COMPARATOR

Sedation using combination of Propofol and Fentanyl.

Intervention Type: DRUG

Patients in whom combination of propofol and fentanyl will be administered during sedation.

Interventions

Sedation using only Propofol.

Patients in whom only propofol will be administered during sedation.

Intervention Type: DRUG

Sedation using combination of Propofol and Fentanyl.

Patients in whom combination of propofol and fentanyl will be administered during sedation.

Intervention Type: DRUG

Other Intervention Names

Propofol; Fentanyl

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Military University Hospital, Prague

OTHER

Sponsor Role: collaborator

Charles University, Czech Republic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ilona Trtíková, Mgr., Ph.D.

Role: STUDY_CHAIR

CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND MILITARY UNIVERSITY HOSPITAL PRAGUE

David Novotný, M.D.

Role: PRINCIPAL_INVESTIGATOR

CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND MILITARY UNIVERSITY HOSPITAL PRAGUE

Tomáš Tyll, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND MILITARY UNIVERSITY HOSPITAL PRAGUE

Michal Soták, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND MILITARY UNIVERSITY HOSPITAL PRAGUE

Locations

Military University Hospital Prague

Prague, Czechia, Czechia

Countries

Czechia

References

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.

Reference Type: BACKGROUND

PMID: 28337439 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25037938 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31313720 (View on PubMed)

Other Identifiers

ExSpironUVN

Identifier Type: -

Identifier Source: org_study_id