Skip to content

Non-invasive Carbon Dioxide Monitoring and Endoscopic Retrograde Cholangiopancreatography Patients

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04481308
Enrollment
150
Registered
2020-07-22
Start date
2022-10-31
Completion date
2022-11-30
Last updated
2022-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Monitoring

Keywords

Non-Invasive, CO2 Monitoring, Conscious Sedation, Adult ERCP

Brief summary

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

Detailed 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 .

Interventions

DRUGpropofol (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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
mparison between CO2 measurement from non-invasive method (Dual guard) during conscious sedation for ERCP and invasive method (arterial blood gases).october 2020mparison between CO2 measurement from non-invasive method (Dual guard) during conscious sedation for ERCP and invasive method (arterial blood gases).

Countries

Egypt

Contacts

Primary ContactSamar Fouad
Samarfouad00@gmail.com01122205439
Backup ContactMohamed Abdel-Moneim Bakr
bakr@aun.eu.eg01223213370

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026