Patient MonitoringNCT04481308
Non-invasive Carbon Dioxide Monitoring and Endoscopic Retrograde Cholangiopancreatography Patients
An observational study of Patient Monitoring, run by Assiut University at 2 sites in Egypt.
Trial summary
CO2 monitoring through non-invasive methods to provide an early warning of hypoventilation during procedural sedation. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Patient Monitoring
- What is being tested?
- propofol (2 mg/kg) and fentanyl (1ug/kg) and 4 liters O2 flow through nasal cannula
- How many people
- 150 participants
- Where
- 2 sitesEgypt
- Study dates
- Oct 2022to Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adult patients aged 20-50 years.
Who may be able to join
- Adult patients aged 20-50 years.
- Males or females.
- Elective Endoscopic Retrograde Cholangiopancreatography Patients
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Medicin
Asyut
- Recruiting
Samar
Asyut
Mohamed Abd elmoembakr, 01223213370, Bakr@aun.eu.eg
Ragaa Ahmed herdan, 01001741748, ragaanesthesis@yahoo.com
About this study
Official title: Reliability of Non-invasive Carbon Dioxide Monitoring During Conscious Sedation for Adult Endoscopic Retrograde Cholangiopancreatography Patients
CO2 monitoring through non-invasive methods to provide an early warning of hypoventilation during procedural sedation.
Read the 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 .
- Conditions
- Patient Monitoring
- Being tested
- propofol (2 mg/kg) and fentanyl (1ug/kg) and 4 liters O2 flow through nasal cannula
- Keywords
- Non-Invasive, CO2 Monitoring, Conscious Sedation, Adult ERCP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofol (2 mg/kg) and fentanyl (1ug/kg) and 4 liters O2 flow through nasal cannulaDrug
propofol (2 mg/kg) and fentanyl (1ug/kg) and 4 liters O2 flow through nasal cannula
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: october 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study startOct 2022 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient MonitoringStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Fouad Yones, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481308
- Sponsor's protocol ID
- non-invasive co2 monitoring
- Status last verified
- Feb 2022
- First submitted
- 14 Jul 2020
- Last updated
- 16 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Non-invasive Carbon Dioxide Monitoring During Conscious Sedation for Adult Endoscopic Retrograde Cholangiopancreatography Patients
- ClinicalTrials.gov ID
- NCT04481308
- Acronym / sponsor ID
- non-invasive co2 monitoring
- Conditions
- Patient Monitoring
- Keywords
- Non-Invasive, CO2 Monitoring, Conscious Sedation, Adult ERCP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult patients aged 20-50 years.
Key inclusion criteria (3 listed)
- Adult patients aged 20-50 years.
- Males or females.
- Elective Endoscopic Retrograde Cholangiopancreatography Patients
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propofol (2 mg/kg) and fentanyl (1ug/kg) and 4 liters O2 flow through nasal cannulapropofol (2 mg/kg) and fentanyl (1ug/kg) and 4 liters O2 flow through nasal cannula | Drug | – |
Primary outcome
mparison between CO2 measurement from non-invasive method (Dual guard) during conscious sedation for ERCP and invasive method (arterial blood gases).
Time frame: october 2020
mparison between CO2 measurement from non-invasive method (Dual guard) during conscious sedation for ERCP and invasive method (arterial blood gases).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Monitoring, run by Assiut University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samar Fouad (01122205439, Samarfouad00@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mparison between CO2 measurement from non-invasive method (Dual guard) during conscious sedation for ERCP and invasive method (arterial blood gases). (time frame: october 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.