Non-invasive Carbon Dioxide Monitoring and Endoscopic Retrograde Cholangiopancreatography Patients

Patient Monitoring Clinical Trial

Official title:

Reliability of Non-invasive Carbon Dioxide Monitoring During Conscious Sedation for Adult Endoscopic Retrograde Cholangiopancreatography Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04481308
• Other study ID #: non-invasive co2 monitoring
• Status: Recruiting
• Start date: October 2022
• Est. completion date: November 2022

Study information

• Verified date: February 2022
• Source: Assiut University
• Contact: Samar Fouad
• Phone: 01122205439
• Email: Samarfouad00[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

CO2 monitoring through non-invasive methods to provide an early warning of hypoventilation during procedural sedation.

Description:

Many patients become hypoxic during endoscopic retrograde cholangiopancreatography (ERCP). Following induced sedation, hypoxia or hypercapnia may follow . Monitoring the CO2 level during respiration (capnography) is non-invasive, easy to do, relatively inexpensive, and has been studied extensively . End-tidal carbon dioxide is the level of CO2 released at the end of an exhaled breath . Capnography provides information about ventilation, perfusion and metabolism . Capnography devices are configured as either side stream or mainstream. Side stream devices can monitor both intubated and non-intubated patients, while mainstream devices are most often limited to intubated patients .

The Dual guard (made in China) sets a standard in endoscopic practices; it incorporates an endoscopy bite block with oxygen delivery and CO2 monitoring for use in upper endoscopy procedures through to recovery . It improves patient safety and meets current guidelines for consciously sedated patients. The Comfort Rest Bite Block fits securely in the mouth, protecting both endoscope and patients' teeth. Simultaneous oral and nasal O2 delivery and CO2 sampling for patients undergoing upper GI endoscopy, in either a lateral or supine position. Arterial blood gas test results show the patient's acid-base balance, which is measured by the hydrogen ion concentration present in the blood, its oxygen saturation, partial pressure of oxygen (PaO2), partial pressure of carbon dioxide (PaCO2), concentration of bicarbonate (HCO3), base excess and base deficit . Itcan provide information about a surgical patient's physiological state, oxygenation, ventilation and indicate the primary source of a disturbance (ie, respiratory or metabolic) in homeostasis .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• Adult patients aged 20-50 years.

• Males or females.

• Elective Endoscopic Retrograde Cholangiopancreatography Patients

Exclusion Criteria:

• Patient with abnormal renal function test.

• Patient with history of chronic chest disease like asthma or Chronic obstructed pulmonary diseases.

• Patients with a history of systemic illness like hypertension and diabetes.

• Cardiac patients.

Related Conditions & MeSH terms

• Patient Monitoring

Intervention

Drug:
• propofol (2 mg/kg) and fentanyl (1ug/kg) and 4 liters O2 flow through nasal cannula
propofol (2 mg/kg) and fentanyl (1ug/kg) and 4 liters O2 flow through nasal cannula

Locations

Country	Name	City	State
Egypt	Medicin	Assiut
Egypt	Samar	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mparison between CO2 measurement from non-invasive method (Dual guard) during conscious sedation for ERCP and invasive method (arterial blood gases).	mparison between CO2 measurement from non-invasive method (Dual guard) during conscious sedation for ERCP and invasive method (arterial blood gases).	october 2020