Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04588272 |
| Other study ID # |
Non invasive EtCO2 monitoring. |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2020 |
| Est. completion date |
December 1, 2021 |
Study information
| Verified date |
March 2022 |
| Source |
Assiut University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
CO2 monitoring through non-invasive methods at different O2 flow rates may provide an early
warning sign of hypoventilation during procedural sedation.
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
1. Patient is anxious and agitated or restless, or both.
2. Patient is co-operative, oriented, and tranquil.
3. Patient responds to commands only.
4. Patient exhibits brisk response to light glabellar tap or loud auditory stimulus.
5. Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus.
6. Patient exhibits no response.
