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Trial record 18 of 1928 for:    CARBON DIOXIDE AND dioxide

End Tidal Carbon Dioxide Monitoring During Moderate Sedation (EtCO2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04588272
Recruitment Status : Not yet recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmed Reda Mohamed, Assiut University

Brief Summary:
CO2 monitoring through non-invasive methods may provide an early warning sign of hypoventilation during procedural sedation.

Condition or disease Intervention/treatment
Carbon Dioxide Device: DualGuard

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Non-invasive Carbon Dioxide Monitoring During Moderate Sedation at Different Oxygen Flow Rates in Patients Undergoing Endoscopic Retrograde Cholangio-pancreatography
Estimated Study Start Date : June 1, 2021
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Group/Cohort Intervention/treatment
2 liters
40 patients will receive O2 supply at rate of 2 liters per minute and then an arterial blood gas (ABG) sample is taken and compared with capnographic measures from DualGuard.
Device: DualGuard
DualGuard device (FlexiCare) which incorporate an endoscopy bite block with oxygen delivery and CO2 monitoring from both the mouth and nose simultaneously.

4 liters
40 patients will receive receive O2 supply at rate 4 liters per minute and then an arterial blood gas (ABG) sample is taken and compared with capnographic measures from DualGuard.
Device: DualGuard
DualGuard device (FlexiCare) which incorporate an endoscopy bite block with oxygen delivery and CO2 monitoring from both the mouth and nose simultaneously.

6 liters
: 40 patients will receive O2 supply at rate 6 liters per minute and then an arterial blood gas (ABG) sample is taken and compared with capnographic measures from DualGuard.
Device: DualGuard
DualGuard device (FlexiCare) which incorporate an endoscopy bite block with oxygen delivery and CO2 monitoring from both the mouth and nose simultaneously.




Primary Outcome Measures :
  1. : Measuring end-tidal carbon dioxide (EtCO2) that is taken during different flows of oxygen(O2) supplementation. [ Time Frame: During the procedure. ]
    : end-tidal carbon dioxide (EtCO2) that is taken during different flows of oxygen(O2) supplementation will be measured.


Secondary Outcome Measures :
  1. : Will include O2 saturation. [ Time Frame: During the procedure. ]
    : Will include O2 saturation.

  2. Haemodynamics. [ Time Frame: During the procedure. ]
    Systolic blood pressure, diastolic blood pressure and mean blood pressure.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
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.

Criteria

Inclusion Criteria:

  • Age: Adult Patients aged 20-60 years.
  • Sex: either male or female.
  • ASA physical status I or II.
  • Elective ERCP

Exclusion Criteria:

  • * Abnormal renal function test.

    • History of asthma or COPD
    • patients with a history of hypertension and diabetes.
    • Cardiac patients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04588272


Contacts
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Contact: Ahmed Reda 01060207415 ahmedredaa265@gmail.com
Contact: Mohamed Fathy 01001123062 Mo7_fathy@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Mohamed Fathy Assiut University
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Responsible Party: Ahmed Reda Mohamed, Resident, Assiut University
ClinicalTrials.gov Identifier: NCT04588272    
Other Study ID Numbers: EtCO2 monitoring.
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed Reda Mohamed, Assiut University:
EtCO2 MONITORING