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

NCT06060626 | Completed

• 1 other identifier: ExSpironUVN
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedation Complication; Ventilatory Depression

Keywords

sedation protocol; endoscopic procedure; ventilation monitoring; ventilatory depression

Outcome Measures

Primary Outcomes (2)

• Incidence of significant decrease in ventilation during propofol sedation.

  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.

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

  during the endoscopic procedure

Secondary Outcomes (2)

• Subjective assessment of the comfort of the procedure by the endoscopist.

  immediately after the procedure

• Subjective assessment of the comfort of the procedure by the patient.

  immediately after the procedure

Study Arms (2)

Propofol

ACTIVE COMPARATOR

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.

Fentanyl

ACTIVE COMPARATOR

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.

Interventions

Sedation using only Propofol. DRUG

Patients in whom only propofol will be administered during sedation.

Also known as: Propofol

Propofol

Sedation using combination of Propofol and Fentanyl. DRUG

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

Also known as: Fentanyl

Fentanyl

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• Military University Hospital, Prague: collaborator

Study Sites (1)

Military University Hospital Prague

Prague, Czechia, 16209, Czechia

Location

Related Publications (3)

• 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.

  PMID: 28337439 BACKGROUND

• 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.

  PMID: 25037938 BACKGROUND

• 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.

  PMID: 31313720 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Propofol; Fentanyl

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ilona Trtíková, Mgr., Ph.D.

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

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The endoscopist performing the procedure will not be informed which group the patient belongs to.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: September 29, 2023
• Study Start: November 16, 2023
• Primary Completion: January 22, 2025
• Study Completion: January 22, 2025
• Last Updated: January 28, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)