Oxygen SaturationNCT06283914
Imputation of Arterial Oxygen Partial Pressures Using Pulse Oximetry
An observational study of Oxygen Saturation and Respiratory Distress Syndrome, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
This study aims to validate existing PaO₂ prediction equations (Rice, Pandharipande, Gadrey, Hill, Severinghaus-Ellis) by comparing predicted PaO₂ values with measured values. If these equations are found to be invalid, new PaO₂ prediction formulas will be derived and validated for accuracy and performance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oxygen Saturation, Respiratory Distress Syndrome, Anesthesia, General
- How many people
- 300 participants
- Where
- 1 siteLebanon
- Study dates
- 5 Mar 2024to 7 Aug 2024
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age >18 years
- Undergoing general anesthesia
Who cannot join
- Patients undergoing cardiac or thoracic surgeries will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Imputation of Arterial Oxygen Partial Pressures Using Pulse Oximetry in Surgical Patients Under General Anesthesia
This study aims to validate existing PaO₂ prediction equations (Rice, Pandharipande, Gadrey, Hill, Severinghaus-Ellis) by comparing predicted PaO₂ values with measured values. If these equations are found to be invalid, new PaO₂ prediction formulas will be derived and validated for accuracy and performance.
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.
Read the detailed 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 validate existing PaO₂ prediction equations (Rice, Pandharipande, Gadrey, Hill, Severinghaus-Ellis) by comparing predicted PaO₂ values with measured values. If these equations are found to be invalid, new PaO₂ prediction formulas will be derived and validated for accuracy and performance.
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. 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.
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2
Partial pressure of oxygen in the arterial blood (PaO2)
Measured: 30 minutes after intubation until extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start5 Mar 2024
- Primary completion7 Aug 2024
- Study completion7 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen SaturationStudies of the same condition, open and under way.
- 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwan Rizk, American University of Beirut Medical Center
- Investigators
- Marwan Rizk, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283914
- Sponsor's protocol ID
- BIO-2024-0011
- Status last verified
- Nov 2024
- First submitted
- 22 Feb 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imputation of Arterial Oxygen Partial Pressures Using Pulse Oximetry in Surgical Patients Under General Anesthesia
- ClinicalTrials.gov ID
- NCT06283914
- Acronym / sponsor ID
- BIO-2024-0011
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 7 Aug 2024 (actual)
- Study completion
- 7 Aug 2024 (actual)
- First posted
- 28 Feb 2024 (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.
This study aims to validate existing PaO₂ prediction equations (Rice, Pandharipande, Gadrey, Hill, Severinghaus-Ellis) by comparing predicted PaO₂ values with measured values. If these equations are found to be invalid, new PaO₂ prediction formulas will be derived and validated for accuracy and performance.
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.
Detailed 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 validate existing PaO₂ prediction equations (Rice, Pandharipande, Gadrey, Hill, Severinghaus-Ellis) by comparing predicted PaO₂ values with measured values. If these equations are found to be invalid, new PaO₂ prediction formulas will be derived and validated for accuracy and performance.
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. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Age >18 years
- Undergoing general anesthesia
Key exclusion criteria (1 listed)
- Patients undergoing cardiac or thoracic surgeries will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PaO2
Time frame: 30 minutes after intubation until extubation
Partial pressure of oxygen in the arterial blood (PaO2)
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 8 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Marwan Rizk, MD principal investigator
American University of Beirut Medical Center
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 Oxygen Saturation and Respiratory Distress Syndrome, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 2 inclusion and 1 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 8 Nov 2024. 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 Lebanon. 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?
PaO2 (time frame: 30 minutes after intubation until extubation). 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 8 Nov 2024.