Carbon DioxideEtCO2NCT04588272
Non Invasive End Tidal Carbon Dioxide Monitoring During Moderate Sedation
An observational study of Carbon Dioxide, run by Assiut University at 1 site in Egypt.
Trial summary
CO2 monitoring through non-invasive methods at different O2 flow rates may provide an early warning sign of hypoventilation during procedural sedation. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Carbon Dioxide
- What is being tested?
- DualGuard
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2020to 1 Dec 2021
- How long will I take part?
- 1 Day
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: : Two days before surgery, patients will visit the outpatient clinic for history taken, clinical assessment and explanation about the study protocol. Laboratory investigations will be performed and patients will be informed that they can stop participation in the study at any time without any loss of service. Patients will receive conscious sedation via propofol 1.5 mg/kg and lidocaine 1 mg/kg and CO2 monitored through non-invasive method. At the end of the procedure, all patients will recover until full consciousness regains and they are able to follow verbal commands. After the desired spontaneous ventilation, the patients will be transferred to the recovery room.
Who may be able to join
- Age: Adult Patients aged 20-60 years.
- Sex: either male or female.
- ASA physical status I or II.
- Elective ERCP
Who cannot join
- Abnormal renal function test.
- History of asthma or COPD
- patients with a history of hypertension and diabetes.
- Cardiac patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Carbon Dioxide Monitoring During Moderate Sedation at Different Oxygen Flow Rates in Patients Undergoing Endoscopic Retrograde Cholangio-pancreatography
CO2 monitoring through non-invasive methods at different O2 flow rates may provide an early warning sign of hypoventilation during procedural sedation.
Read the detailed description
Sedation is a drug-induced depression in the level of consciousness. The clinical objectives of administering sedation for GI endoscopy are to relieve patient anxiety and discomfort, improve the outcome of the examination, and diminish the patient's memory of the event. A number of different sedatives and analgesics can be used to achieve appropriate levels of sedation for GI endoscopic procedures. The targeted level of sedation may vary depending on patient and procedural variables, and doses of sedatives should be titrated accordingly to achieve a safe, comfortable, and technically successful endoscopic procedure. Knowledge of the pharmacologic profiles of sedation agents is necessary to maximize the likelihood that the desired level of sedation is achieved.(1) All patients receiving sedation to facilitate endoscopic procedures should have monitoring of cardiorespiratory parameters before, during, and after administration of sedation/analgesia. Electronic monitoring may detect early signs of patient distress and is an adjunct to continuous clinical assessment. Commonly used monitoring equipment for patients undergoing endoscopic procedures includes pulse oximetry, single-lead continuous electrocardiographic (ECG) monitoring, and automated blood pressure monitoring. With the increased use of propofol to facilitate endoscopy in recent years, less familiar monitoring devices have been introduced, including end-tidal carbon dioxide (EtCO2) and level of consciousness monitors. Given a recent change in the American Society of Anesthesiologists (ASA) guidelines, recommending CO2 monitoring for patients undergoing both moderate and deep sedation, familiarity with capnography may become necessary.(2) Patients are at risk of respiratory depression and acute hypercapnia during sedation and recovery from anaesthesia . Desaturation on pulse oximetry for monitoring of hypoventilation is a late sign. Moreover, hypoventilation is masked by administration of supplemental O2. ( 3) For a sedated patient in spontaneous ventilation, hypoventilation (by airway obstruction or central respiratory depression) will likely precede hypoxemia. Hence, if the patient is monitored using a capnograph machine, when hypoventilation occurs, PEtCO2 increases and the shape of the capnography curve is modified.This may trigger an adequate response from the person monitoring the anesthesia (chin thrust, sedative dose modification, oxygen supplementation) so as to prevent hypoxemia. (5) Measuring CO2 noninvasively includes capnography and capnometry. capnography provides numerical and graphical (waveforms) forms, while capnometry provides only numerical form. (6) Arterial blood gas (ABG) can tell us about the patient's acid-base balance, which is measured by the hydrogen ion (H) concentration in the blood (pH), oxygen saturation (SaO2), partial pressure of oxygen (PaO2), partial pressure of carbon dioxide (PaCO2), concentration of bicarbonate (HCO3), base excess and base deficit.(7) ABG results can indicate how effectively the patient's body is compensating for the acid-base disturbance and whether the patient's total blood volume is adequate for transporting all the nutrients that the body's tissues require. (8)
Hyopthesis of this trial: is CO2 monitoring through non-invasive methods may provide an early warning sign of hypoventilation during procedural sedation.
Primary outcome: Measuring end-tidal carbon dioxide (EtCO2) that is taken during different flows of oxygen(O2) supplementation.
Secondary outcome: Will include O2 saturation, haemodynamics (systolic blood pressure, diastolic blood pressure and mean blood pressure), time to recovery, patient satisfaction, Ramsay sedation scale (which is used to measure level of sedation through dividing patients level of sedation into 6 categories ranging from severe agitation to deep coma). (9) Ramsay Sedation Scale
- Patient is anxious and agitated or restless, or both.
- Patient is co-operative, oriented, and tranquil.
- Patient responds to commands only.
- Patient exhibits brisk response to light glabellar tap or loud auditory stimulus.
- Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus.
- Patient exhibits no response.
- Conditions
- Carbon Dioxide
- Being tested
- DualGuard
- Keywords
- Non invasive EtCO2 MONITORING
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DualGuardDevice
DualGuard device (FlexiCare) which incorporate an endoscopy bite block with oxygen delivery and CO2 monitoring from both the mouth and nose simultaneously.
| Study group | Role | What they receive |
|---|---|---|
| 2 liters | 40 patients will receive O2 supply at rate of 2 liters per minute and then cabnographic and other measures will be recorded through out the procedure. Receives: Device: DualGuard | |
| 4 liters | 40 patients will receive receive O2 supply at rate 4 liters per minute and then cabnographic and other measures will be recorded through out the procedure. Receives: Device: DualGuard | |
| 6 liters | : 40 patients will receive O2 supply at rate 6 liters per minute and then cabnographic and other measures will be recorded through out the procedure. Receives: Device: DualGuard |
What is being measured
The primary outcome is the main question the study is designed to answer.
End-tidal carbon dioxide
: end-tidal carbon dioxide (EtCO2) that is taken during different flows of oxygen(O2) supplementation will be measured.
Measured: During the procedure.
Secondary outcomes (2)
Oxygen saturation.
: Measuring O2 saturation at different O2 flow rates.
Measured: During the procedure.
Haemodynamics as blood pressure.
Measuring systolic blood pressure, diastolic blood pressure and mean blood pressure.
Measured: During the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Jun 2020
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbon DioxideStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Reda Mohamed, Assiut University
- Investigators
- Mohamed Fathy, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588272
- Sponsor's protocol ID
- Non invasive EtCO2 monitoring.
- Acronym
- EtCO2
- Status last verified
- Mar 2022
- First submitted
- 28 Apr 2020
- Last updated
- 18 Mar 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 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Carbon Dioxide Monitoring During Moderate Sedation at Different Oxygen Flow Rates in Patients Undergoing Endoscopic Retrograde Cholangio-pancreatography
- ClinicalTrials.gov ID
- NCT04588272
- Acronym / sponsor ID
- EtCO2 / Non invasive EtCO2 monitoring.
- Conditions
- Carbon Dioxide
- Keywords
- Non invasive EtCO2 MONITORING
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 19 Oct 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 at different O2 flow rates may provide an early warning sign of hypoventilation during procedural sedation.
Detailed description
Sedation is a drug-induced depression in the level of consciousness. The clinical objectives of administering sedation for GI endoscopy are to relieve patient anxiety and discomfort, improve the outcome of the examination, and diminish the patient's memory of the event. A number of different sedatives and analgesics can be used to achieve appropriate levels of sedation for GI endoscopic procedures. The targeted level of sedation may vary depending on patient and procedural variables, and doses of sedatives should be titrated accordingly to achieve a safe, comfortable, and technically successful endoscopic procedure. Knowledge of the pharmacologic profiles of sedation agents is necessary to maximize the likelihood that the desired level of sedation is achieved.(1) All patients receiving sedation to facilitate endoscopic procedures should have monitoring of cardiorespiratory parameters before, during, and after administration of sedation/analgesia. Electronic monitoring may detect early signs of patient distress and is an adjunct to continuous clinical assessment. Commonly used monitoring equipment for patients undergoing endoscopic procedures includes pulse oximetry, single-lead continuous electrocardiographic (ECG) monitoring, and automated blood pressure monitoring. With the increased use of propofol to facilitate endoscopy in recent years, less familiar monitoring devices have been introduced, including end-tidal carbon dioxide (EtCO2) and level of consciousness monitors. Given a recent change in the American Society of Anesthesiologists (ASA) guidelines, recommending CO2 monitoring for patients undergoing both moderate and deep sedation, familiarity with capnography may become necessary.(2) Patients are at risk of respiratory depression and acute hypercapnia during sedation and recovery from anaesthesia . Desaturation on pulse oximetry for monitoring of hypoventilation is a late sign. Moreover, hypoventilation is masked by administration of supplemental O2. ( 3) For a sedated patient in spontaneous ventilation, hypoventilation (by airway obstruction or central respiratory depression) will likely precede hypoxemia. Hence, if the patient is monitored using a capnograph machine, when hypoventilation occurs, PEtCO2 increases and the shape of the capnography curve is modified.This may trigger an adequate response from the person monitoring the anesthesia (chin thrust, sedative dose modification, oxygen supplementation) so as to prevent hypoxemia. (5) Measuring CO2 noninvasively includes capnography and capnometry. capnography provides numerical and graphical (waveforms) forms, while capnometry provides only numerical form. (6) Arterial blood gas (ABG) can tell us about the patient's acid-base balance, which is measured by the hydrogen ion (H) concentration in the blood (pH), oxygen saturation (SaO2), partial pressure of oxygen (PaO2), partial pressure of carbon dioxide (PaCO2), concentration of bicarbonate (HCO3), base excess and base deficit.(7) ABG results can indicate how effectively the patient's body is compensating for the acid-base disturbance and whether the patient's total blood volume is adequate for transporting all the nutrients that the body's tissues require. (8)
Hyopthesis of this trial: is CO2 monitoring through non-invasive methods may provide an early warning sign of hypoventilation during procedural sedation.
Primary outcome: Measuring end-tidal carbon dioxide (EtCO2) that is taken during different flows of oxygen(O2) supplementation.
Secondary outcome: Will include O2 saturation, haemodynamics (systolic blood pressure, diastolic blood pressure and mean blood pressure), time to recovery, patient satisfaction, Ramsay sedation scale (which is used to measure level of sedation through dividing patients level of sedation into 6 categories ranging from severe agitation to deep coma). (9) Ramsay Sedation Scale
- Patient is anxious and agitated or restless, or both.
- Patient is co-operative, oriented, and tranquil.
- Patient responds to commands only.
- Patient exhibits brisk response to light glabellar tap or loud auditory stimulus.
- Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus.
- Patient exhibits no response.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 liters | – | Device: DualGuard40 patients will receive O2 supply at rate of 2 liters per minute and then cabnographic and other measures will be recorded through out the procedure. |
| 4 liters | – | Device: DualGuard40 patients will receive receive O2 supply at rate 4 liters per minute and then cabnographic and other measures will be recorded through out the procedure. |
| 6 liters | – | Device: DualGuard: 40 patients will receive O2 supply at rate 6 liters per minute and then cabnographic and other measures will be recorded through out the procedure. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- : Two days before surgery, patients will visit the outpatient clinic for history taken, clinical assessment and explanation about the study protocol. Laboratory investigations will be performed and patients will be informed that they can stop participation in the study at any time without any loss of service. Patients will receive conscious sedation via propofol 1.5 mg/kg and lidocaine 1 mg/kg and CO2 monitored through non-invasive method. At the end of the procedure, all patients will recover until full consciousness regains and they are able to follow verbal commands. After the desired spontaneous ventilation, the patients will be transferred to the recovery room.
Key inclusion criteria (4 listed)
- Age: Adult Patients aged 20-60 years.
- Sex: either male or female.
- ASA physical status I or II.
- Elective ERCP
Key exclusion criteria (4 listed)
- Abnormal renal function test.
- History of asthma or COPD
- patients with a history of 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 |
|---|---|---|
| DualGuardDualGuard device (FlexiCare) which incorporate an endoscopy bite block with oxygen delivery and CO2 monitoring from both the mouth and nose simultaneously. | Device | 2 liters, 4 liters, 6 liters |
Primary outcome
End-tidal carbon dioxide
Time frame: During the procedure.
: end-tidal carbon dioxide (EtCO2) that is taken during different flows of oxygen(O2) supplementation will be measured.
2 secondary outcomes
Oxygen saturation.
Time frame: During the procedure.
Haemodynamics as blood pressure.
Time frame: During the procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 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.
Mohamed Fathy study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carbon Dioxide, run by Assiut University at 1 site 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 4 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: finished, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End-tidal carbon dioxide (time frame: During the procedure.). 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 18 Mar 2022.