Clinical Trials Logo
  1. Home
  2. Respiratory Distress Syndrome
  3. NCT06283914
  4. Details
NCT06283914 Clinical Trial

Imputation of Arterial Oxygen Partial Pressures Using Pulse Oximetry

Respiratory Distress Syndrome Clinical Trial

Official title:
Imputation of Arterial Oxygen Partial Pressures Using Pulse Oximetry in Surgical Patients Under General Anesthesia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06283914
Other study ID # BIO-2024-0011
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 5, 2024
Est. completion date September 1, 2024

Study information
Verified date June 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, Pandharipande, and Gadrey 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, Pandharipande, and Gadrey 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date September 1, 2024
Est. primary completion date August 1, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age >18 years - Undergoing general anesthesia Exclusion Criteria: - Patients undergoing cardiac or thoracic surgeries will be excluded.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Lebanon American University of Beirut Medical Center Beirut

Sponsors (1)
Lead Sponsor Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome
Type Measure Description Time frame Safety issue
Other SpO2 oxygen saturation (SpO2) 30 minutes after intubation until extubation
Primary PaO2 Partial pressure of oxygen in the arterial blood (PaO2) 30 minutes after intubation until extubation
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06168149 - The Relationship of Fetal Lung Elastography Values With the Development of Respiratory Distress in Cases of Preterm Labor
Recruiting NCT03670732 - CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure N/A
Recruiting NCT02901652 - NIPPV and nBiPAP Methods in Preterm Infants With Respiratory Distress Syndrome N/A
Completed NCT02249143 - Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants N/A
Suspended NCT01852916 - NHFOV Versus NCPAP to Prevent Exubation Failure N/A
Completed NCT00208039 - Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates N/A
Recruiting NCT03510169 - Use of Gentle Synchronized Negative Pressure in Helping Babies Breathe N/A
Completed NCT00004494 - Phase I Study of Vasoactive Intestinal Peptide in Patients With Acute Respiratory Distress Syndrome and Sepsis Phase 1
Completed NCT00006058 - Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns N/A
Completed NCT00004805 - Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents With Infants at Risk of Sudden Death N/A
Completed NCT03292562 - A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation N/A
Completed NCT05948332 - Definition and Management of Right Ventricular Injury in Adult Patients Receiving Extracorporeal Membrane Oxygenation
Completed NCT05038514 - The Effect of Music Therapy in COVID-19 Patients Given Prone Position N/A
Active, not recruiting NCT04079829 - Postoperative Respiratory Abnormalities
Completed NCT05462509 - Feasibility of Use of the PATH bCPAP and Oxygen Blenders Device With Neonates in Uganda N/A
Active, not recruiting NCT03808402 - The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS
Completed NCT01812681 - Cord Blood 25(oh)-Vitamin D Level in Preterm Infants and Associated Morbidities N/A
Completed NCT01517958 - Lung Ultrasound to Diagnose Transient Tachypnea of the Newborn (TTN) Versus Respiratory Distress Syndrome (RDS) in Neonates N/A
Not yet recruiting NCT01440868 - Sustained Lung Inflation in the Delivery Room in Preterm Infants at High Risk of Respiratory Distress Syndrome N/A
Completed NCT01222247 - Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial Phase 3