Non-invasive Carbon Dioxide Monitoring and Endoscopic Retrograde Cholangiopancreatography Patients

NCT ID: NCT04481308

Last Updated: 2022-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-31

Study Completion Date

2022-11-30

Brief Summary

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

Detailed Description

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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 .

Conditions

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Patient Monitoring

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Samar Fouad Yones

Resident of anesthesia and intensive care

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medicin

Asyut, , Egypt

Site Status RECRUITING

Samar

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Samar Fouad

Role: CONTACT

01122205439

Mohamed Abdel-Moneim Bakr

Role: CONTACT

01223213370

Facility Contacts

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Mohamed Abd elmoembakr

Role: primary

01223213370

Ragaa Ahmed herdan

Role: backup

01001741748

Other Identifiers

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non-invasive co2 monitoring

Identifier Type: -

Identifier Source: org_study_id

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