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

Sedation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06060626
• Other study ID #: ExSpironUVN
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Charles University, Czech Republic
• Contact: Ilona Trtíková, Mgr., Ph.D.
• Phone: +420224965613
• Email: ilona.trtikova[@]clf1.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Respiratory Insufficiency
• Sedation Complication
• Ventilatory Depression

Intervention

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

Locations

Country	Name	City	State
Czechia	Military University Hospital Prague	Praha

Sponsors (2)

Lead Sponsor	Collaborator
Charles University, Czech Republic	Military University Hospital, Prague

Country where clinical trial is conducted

Czechia, 

References & Publications (3)

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. — View 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 — View 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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	immediately after the procedure
Secondary	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.	immediately after the procedure