Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06283914 |
Other study ID # |
BIO-2024-0011 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
March 1, 2024 |
Est. completion date |
September 1, 2024 |
Study information
Verified date |
February 2024 |
Source |
American University of Beirut Medical Center |
Contact |
Marwan Rizk, MD |
Phone |
01350000 |
Email |
mr04[@]aub.edu.lb |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The goal of this is prospective cohort study is to to study the relationship between PaO2 and
SpO2 in the overall population undergoing general anesthesia in the OT. Secondary aims
include studying the relationship between PaO2 and SpO2 in elderly and obese patients
undergoing general anesthesia in the OT, validating the derivation of PaO2 from SpO2 using
formulas derived by Rice et al. (2009), Pandharipande et al. (2009), and Gadrey et al. (2019)
in patients undergoing general anesthesia in the OT, and, if the derivation formulas were not
valid, to derive a formula for patients undergoing general anesthesia in the OT.
The included blood samples are arterial blood sample collected for ABGs analysis through
either an arterial catheter or an arterial blood puncture in adult patients (Age >18 years)
undergoing general anesthesia regardless of the acuity of the surgery (elective, emergency,
or lifesaving), the hemodynamic stability of the patient, or the comorbidities. Patients
undergoing cardiac or thoracic surgeries will be excluded.
Description:
The partial pressure of oxygen in the arterial blood (PaO2) / the fraction of inspired oxygen
(FiO2) ratio has been commonly used as an indicator of adequate oxygenation and in the
diagnosis and severity of acute respiratory distress syndrome (ARDS) which requires arterial
blood gas (ABGs) analysis. Another way to measure oxygenation is by using the noninvasive
pulse oximetry to measure the oxygen saturation (SpO2). Three formulas have been derived and
validated in the intensive care unit (ICU) setting to estimate the PaO2 from the SpO2.
However, the relationship of PaO2 and SpO2 and these derivation equations are not validated
in the setting of general anesthesia in the operating theatre (OT) in which patients are
prone to multiple intraoperative and postoperative pulmonary complications.
The aim is to study the relationship between PaO2 and SpO2 in the overall population
undergoing general anesthesia in the OT. Secondary aims include studying the relationship
between PaO2 and SpO2 in elderly and obese patients undergoing general anesthesia in the OT,
validating the derivation of PaO2 from SpO2 using formulas derived by Rice et al. (2009),
Pandharipande et al. (2009), and Gadrey et al. (2019) in patients undergoing general
anesthesia in the OT, and, if the derivation formulas were not valid, to derive a formula for
patients undergoing general anesthesia in the OT.
This is a prospective cohort study that will be conducted at the American University of
Beirut Medical Center (AUBMC) in the OT under the Department of Anesthesiology and Pain
Medicine. The data will be collected by the investigators of the study from the patient's
chart on EPIC. These include the PaO2 (in mmHg), FiO2, SpO2 (in %), and Mean airway pressure
(in cmH2O) at the time of sample collection, in addition to patient characteristics as age,
gender, weight, height, BMI, smoking status, surgery type, surgery acuity, and present
comorbidities specifically cardiac and respiratory comorbidities.
Validating the use of one of the formulas to derive PaO2 from SpO2 in the OT would help
anesthesiologists detect derangements in patients' oxygenation earlier and decrease the need
for ABGs analysis and its possible complications.