Atelectases, Postoperative PulmonaryNCT07375173
ORI-Guided FiO₂ Titration in Prone Spine Surgery: Impact on Postoperative Atelectasis Assessed by Lung Ultrasound
A study testing Titrated Oxygen and Fixed oxygen in people with Atelectases, Postoperative Pulmonary and Prone Position, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Atelectasis is a frequent pulmonary complication after general anesthesia, often triggered by preoxygenation and intraoperative hyperoxia. High inspiratory oxygen fractions (FiO₂) can promote absorption atelectasis, ventilation-perfusion mismatch, hemodynamic alterations, and oxidative injury. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atelectases, Postoperative Pulmonary, Prone Position, Spine Surgery
- What is being tested?
- Titrated Oxygen and Fixed oxygen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2026to 20 Oct 2026
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 80 years
- Patients with an ASA physical status of I, II, or III
- Individuals with a body mass index (BMI) between 18 and 35 kg/m²
Who cannot join
- History of or active upper or lower respiratory tract infection within the past month
- Pulmonary emphysematous/bullous disease or COPD
- Pre-existing significant atelectasis or consolidation (Preoperative LUS showing a score of 3 consolidation or ≥2 regions with a score ≥2)
- Severe obstructive sleep apnea requiring CPAP therapy
- NYHA class III-IV heart failure, EF <35%, or severe valvular disease
- Severe arrhythmia or hemodynamic instability requiring high-dose vasopressors
Show all 11Show fewer
- Body mass index (BMI) >35 kg/m²
- Severe anemia (Hb <9 g/dL) or polycythemia (Hb >18 g/dL)
- Non-diagnostic or unclear preoperative lung ultrasound images
- Preoperative SpO₂ ≤ 94%
- Inability to apply the sensor due to finger deformity, or inadequate signal caused by digital hypoperfusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oxygen Reserve Index-Guided FiO₂ Titration in Prone Spine Surgery: Impact on Postoperative Atelectasis Assessed by Lung Ultrasound
Atelectasis is a frequent pulmonary complication after general anesthesia, often triggered by preoxygenation and intraoperative hyperoxia. High inspiratory oxygen fractions (FiO₂) can promote absorption atelectasis, ventilation-perfusion mismatch, hemodynamic alterations, and oxidative injury.
This study evaluates the effect of two intraoperative oxygen management strategies-oxygen reserve index (ORI)-guided FiO₂ titration versus fixed 50% FiO₂-on postoperative atelectasis in patients undergoing thoracolumbar spine surgery under general anesthesia. Atelectasis severity will be assessed using lung ultrasonography (LUS), scored across 12 thoracic regions (0-3 per region, total 0-36), while respiratory function changes will be examined via preoperative and 24-hour postoperative spirometry (FVC, FEV₁, FEV₁/FVC).
Read more
Because postoperative spirometry may be influenced by pain, Numeric Rating Scale (NRS) scores will be recorded to help distinguish true restrictive patterns from pain-limited respiratory effort.
The study aims to determine whether ORI-guided FiO₂ titration can reduce postoperative atelectasis and improve respiratory outcomes compared with a fixed FiO₂ approach.
Read the detailed description
Atelectasis is one of the most common pulmonary complications following general anesthesia, and both preoxygenation and intraoperative hyperoxia are major contributing factors. Hyperoxia can lead to absorption atelectasis, ventilation-perfusion mismatch, cerebral and coronary vasoconstriction, decreased cardiac output, and oxidative tissue injury caused by reactive oxygen species. The use of a high inspiratory oxygen fraction (FiO₂) during general anesthesia, particularly in prolonged surgeries, increases the risk of absorption atelectasis.
This study aims to investigate the impact of different intraoperative oxygen management strategies-oxygen reserve index (ORI)-guided FiO₂ titration versus fixed 50% FiO₂-on the development of postoperative atelectasis in patients undergoing thoracolumbar spine surgery under general anesthesia. The presence and severity of atelectasis will be assessed using lung ultrasonography (LUS), and changes in respiratory function will be evaluated objectively through spirometry measurements.
Lung ultrasonography will be performed by the same experienced and certified anesthesia practitioner for both groups. LUS assessment will be conducted in 12 regions (superior and inferior zones along the anterior, lateral, and posterior lines of each hemithorax). Each region will be scored from 0 to 3 according to the degree of aeration:
0 = normal aeration (A-lines predominance, <2 B-lines);
- = mild loss of aeration (≥3 well-defined B-lines);
- = moderate loss of aeration (multiple coalescent B-lines or "white lung");
- = severe loss of aeration (subpleural or complete consolidation with air bronchograms).
The total LUS score ranges from 0 to 36, with higher scores indicating greater loss of aeration and presence of atelectasis.
Spirometry will be performed preoperatively and at 24 hours postoperatively, with patients in a seated position using a nose clip and a single-use cardboard mouthpiece. After a maximal inspiration, patients will be instructed to perform a forceful and sustained expiration according to device guidance. At least three maneuvers will be recorded, and the best values for FVC, FEV₁, and FEV₁/FVC will be documented.
Postoperative spirometry results may be influenced by pain, as inadequate inspiration or shortened expiration can lead to artificially reduced FVC and FEV₁ values. Therefore, postoperative pain will be assessed using the Numeric Rating Scale (NRS, 0-10), enabling differentiation between true atelectasis-related restrictive patterns and pain-limited respiratory effort.
This study focuses on optimizing oxygenation and preventing postoperative pulmonary atelectasis caused by higher intraoperative oxygen exposure in patients undergoing elective thoracolumbar spine surgery under general anesthesia.
- Conditions
- Atelectases, Postoperative Pulmonary, Prone Position, Spine Surgery, Lung Ultrasound, Oxygen Reserve Index
- Being tested
- Titrated Oxygen, Fixed oxygen
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titrated OxygenProcedure or surgery
Also called Oxygen Reserve Index-Guided Oxygen Titration
This intervention is distinguished by the use of real-time Oxygen Reserve Index (ORI) monitoring to guide individualized intraoperative FiO₂ titration. Unlike fixed-FiO₂ strategies commonly used in anesthesia practice, this protocol continuously adjusts FiO₂ based on ORI values measured with the Masimo Rad-97 device. FiO₂ is increased or decreased in increments of 0.05 according to predefined ORI thresholds to maintain patients within a targeted normoxemic range. The intervention is entirely noninvasive and integrates standardized lung ultrasound (LUS) assessments and spirometry to evaluate postoperative aeration loss and respiratory function. This dynamic, physiology-based oxygen management approach differentiates the intervention from routine fixed-oxygen administration used in other clinical studies.
Fixed oxygenProcedure or surgery
Also called fixed 50:50 oxygen and air combination
This intervention uses a standard, non-individualized oxygen administration approach in which FiO₂ is maintained at a constant 50% throughout the entire surgical procedure. After preoxygenation with 80% FiO₂ for 3 minutes, the FiO₂ is set at 0.50 immediately after intubation and is not modified in response to patient physiology or ORI measurements. PEEP is fixed at 5 cmH₂O, and a standardized alveolar recruitment maneuver is applied at the beginning of surgery. This fixed-FiO₂ strategy differs from the ORI-guided titration group by avoiding dynamic oxygen adjustments and reflects conventional intraoperative oxygen management commonly used in clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Group 1-ORI-Guided FiO₂ Titration Group | Active comparator | Patients will receive 80% FiO₂ for 3 minutes before induction. After intubation, FiO₂ will be set to 50% and titrated to keep the Oxygen Reserve Index (ORI) between 0.00-0.05 using the Masimo Rad-97. If ORI ≥0.05 for ≥5 min, FiO₂ will be reduced by 0.05; if ORI stays within 0-0.05 for ≥5 min, FiO₂ will be maintained; if ORI = 0 with SpO₂ <95%, FiO₂ will be increased by 0.05. The target PaO₂ is 80-120 mmHg. PEEP will be fixed at 5 cmH₂O, and a standard recruitment maneuver will be applied at surgery start. The protocol continues throughout the operation. Only noninvasive methods (ORI, LUS, spirometry) will be used. Both groups will have preoperative LUS and spirometry. Postoperative LUS will be repeated at 30 minutes and spirometry at 24 hours for comparative assessment. Receives: Procedure: Titrated Oxygen |
| Group 2- Fixed FiO₂ | Active comparator | Patients will undergo preoxygenation with 80% FiO₂ for 3 minutes prior to induction. After endotracheal intubation, FiO₂ will be maintained at 50% and continued unchanged throughout the surgical procedure. Positive end-expiratory pressure (PEEP) will be set at 5 cmH₂O, and a standard alveolar recruitment maneuver will be applied to all patients at the beginning of surgery.
The intervention will be continued throughout the surgical procedure. Only noninvasive monitoring (ORI measurement), lung ultrasonography (LUS), and spirometry will be performed in this study. In both groups, preoperative spirometry and lung ultrasonography will be conducted. Postoperatively, lung ultrasonography will be repeated at the 30th minute, and spirometry will be repeated at the 24th hour to allow for comparative analysis. Receives: Procedure: Fixed oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Lung Ultrasound (LUS) Score
The primary outcome of the study is the change in the total Lung Ultrasound (LUS) score obtained using a standardized 12-zone lung ultrasound protocol. Each hemithorax was evaluated in six regions-anterior, lateral, and posterior lines, each divided into superior and inferior zones-resulting in a total of 12 assessed areas. Each zone was scored from 0 to 3 based on the degree of aeration, yielding a total score ranging from 0 to 36, with higher scores indicating greater aeration loss and atelectasis. Accordingly, the difference between the preoperative LUS score and the LUS score measured at 30 minutes after extubation was defined as the primary endpoint of the study.
Measured: Baseline (Preoperative) and 30 Minutes After Extubation
Secondary outcomes (3)
Change in Forced Vital Capacity (FVC)
Spirometry is performed preoperatively and repeated at 24 hours postoperatively. Forced Vital Capacity (FVC) is defined as the total volume of air that can be forcibly exhaled from the lungs after a maximal inhalation.
Measured: Baseline (Preoperative) and Postoperative 24th Hour
Change in Forced Expiratory Volume in 1 Second (FEV1)
Spirometry is performed preoperatively and repeated at 24 hours postoperatively. FEV1 is defined as the volume of air exhaled during the first second of a forced expiration.
Measured: Baseline (Preoperative) and Postoperative 24th Hour
Change in FEV1/FVC Ratio
Spirometry is performed preoperatively and repeated at 24 hours postoperatively. The ratio is calculated by dividing the Forced Expiratory Volume in 1 Second (FEV1) by the Forced Vital Capacity (FVC). The result is multiplied by 100 and expressed as a percentage.
Measured: Baseline (Preoperative) and Postoperative 24th Hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start15 Mar 2026
- Primary completion30 Sep 2026
- Study completion20 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atelectases, Postoperative PulmonaryStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sıla Soytaş, Ankara Etlik City Hospital
- Investigators
- Derya Özkan, Professor, Study director, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375173
- Sponsor's protocol ID
- AEŞH-EK-2025-301
- Status last verified
- Oct 2026
- First submitted
- 19 Nov 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Reserve Index-Guided FiO₂ Titration in Prone Spine Surgery: Impact on Postoperative Atelectasis Assessed by Lung Ultrasound
- ClinicalTrials.gov ID
- NCT07375173
- Acronym / sponsor ID
- AEŞH-EK-2025-301
- Conditions
- Atelectases, Postoperative Pulmonary, Prone Position, Spine Surgery, Lung Ultrasound, Oxygen Reserve Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 20 Oct 2026 (actual)
- First posted
- 29 Jan 2026 (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.
Atelectasis is a frequent pulmonary complication after general anesthesia, often triggered by preoxygenation and intraoperative hyperoxia. High inspiratory oxygen fractions (FiO₂) can promote absorption atelectasis, ventilation-perfusion mismatch, hemodynamic alterations, and oxidative injury.
This study evaluates the effect of two intraoperative oxygen management strategies-oxygen reserve index (ORI)-guided FiO₂ titration versus fixed 50% FiO₂-on postoperative atelectasis in patients undergoing thoracolumbar spine surgery under general anesthesia. Atelectasis severity will be assessed using lung ultrasonography (LUS), scored across 12 thoracic regions (0-3 per region, total 0-36), while respiratory function changes will be examined via preoperative and 24-hour postoperative spirometry (FVC, FEV₁, FEV₁/FVC).
Because postoperative spirometry may be influenced by pain, Numeric Rating Scale (NRS) scores will be recorded to help distinguish true restrictive patterns from pain-limited respiratory effort.
The study aims to determine whether ORI-guided FiO₂ titration can reduce postoperative atelectasis and improve respiratory outcomes compared with a fixed FiO₂ approach.
Detailed description
Atelectasis is one of the most common pulmonary complications following general anesthesia, and both preoxygenation and intraoperative hyperoxia are major contributing factors. Hyperoxia can lead to absorption atelectasis, ventilation-perfusion mismatch, cerebral and coronary vasoconstriction, decreased cardiac output, and oxidative tissue injury caused by reactive oxygen species. The use of a high inspiratory oxygen fraction (FiO₂) during general anesthesia, particularly in prolonged surgeries, increases the risk of absorption atelectasis.
This study aims to investigate the impact of different intraoperative oxygen management strategies-oxygen reserve index (ORI)-guided FiO₂ titration versus fixed 50% FiO₂-on the development of postoperative atelectasis in patients undergoing thoracolumbar spine surgery under general anesthesia. The presence and severity of atelectasis will be assessed using lung ultrasonography (LUS), and changes in respiratory function will be evaluated objectively through spirometry measurements.
Lung ultrasonography will be performed by the same experienced and certified anesthesia practitioner for both groups. LUS assessment will be conducted in 12 regions (superior and inferior zones along the anterior, lateral, and posterior lines of each hemithorax). Each region will be scored from 0 to 3 according to the degree of aeration:
0 = normal aeration (A-lines predominance, <2 B-lines);
- = mild loss of aeration (≥3 well-defined B-lines);
- = moderate loss of aeration (multiple coalescent B-lines or "white lung");
- = severe loss of aeration (subpleural or complete consolidation with air bronchograms).
The total LUS score ranges from 0 to 36, with higher scores indicating greater loss of aeration and presence of atelectasis.
Spirometry will be performed preoperatively and at 24 hours postoperatively, with patients in a seated position using a nose clip and a single-use cardboard mouthpiece. After a maximal inspiration, patients will be instructed to perform a forceful and sustained expiration according to device guidance. At least three maneuvers will be recorded, and the best values for FVC, FEV₁, and FEV₁/FVC will be documented.
Postoperative spirometry results may be influenced by pain, as inadequate inspiration or shortened expiration can lead to artificially reduced FVC and FEV₁ values. Therefore, postoperative pain will be assessed using the Numeric Rating Scale (NRS, 0-10), enabling differentiation between true atelectasis-related restrictive patterns and pain-limited respiratory effort.
This study focuses on optimizing oxygenation and preventing postoperative pulmonary atelectasis caused by higher intraoperative oxygen exposure in patients undergoing elective thoracolumbar spine surgery under general anesthesia.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1-ORI-Guided FiO₂ Titration Group | Active comparator | Procedure: Titrated OxygenPatients will receive 80% FiO₂ for 3 minutes before induction. After intubation, FiO₂ will be set to 50% and titrated to keep the Oxygen Reserve Index (ORI) between 0.00-0.05 using the Masimo Rad-97. If ORI ≥0.05 for ≥5 min, FiO₂ will be reduced by 0.05; if ORI stays within 0-0.05 for ≥5 min, FiO₂ will be maintained; if ORI = 0 with SpO₂ <95%, FiO₂ will be increased by 0.05. The target PaO₂ is 80-120 mmHg. PEEP will be fixed at 5 cmH₂O, and a standard recruitment maneuver will be applied at surgery start. The protocol continues throughout the operation. Only noninvasive methods (ORI, LUS, spirometry) will be used. Both groups will have preoperative LUS and spirometry. Postoperative LUS will be repeated at 30 minutes and spirometry at 24 hours for comparative assessment. |
| Group 2- Fixed FiO₂ | Active comparator | Procedure: Fixed oxygenPatients will undergo preoxygenation with 80% FiO₂ for 3 minutes prior to induction. After endotracheal intubation, FiO₂ will be maintained at 50% and continued unchanged throughout the surgical procedure. Positive end-expiratory pressure (PEEP) will be set at 5 cmH₂O, and a standard alveolar recruitment maneuver will be applied to all patients at the beginning of surgery. The intervention will be continued throughout the surgical procedure. Only noninvasive monitoring (ORI measurement), lung ultrasonography (LUS), and spirometry will be performed in this study. In both groups, preoperative spirometry and lung ultrasonography will be conducted. Postoperatively, lung ultrasonography will be repeated at the 30th minute, and spirometry will be repeated at the 24th hour to allow for comparative analysis. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 to 80 years
- Patients with an ASA physical status of I, II, or III
- Individuals with a body mass index (BMI) between 18 and 35 kg/m²
Key exclusion criteria (11 listed)
- History of or active upper or lower respiratory tract infection within the past month
- Pulmonary emphysematous/bullous disease or COPD
- Pre-existing significant atelectasis or consolidation (Preoperative LUS showing a score of 3 consolidation or ≥2 regions with a score ≥2)
- Severe obstructive sleep apnea requiring CPAP therapy
- NYHA class III-IV heart failure, EF <35%, or severe valvular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Titrated OxygenAlso: Oxygen Reserve Index-Guided Oxygen TitrationThis intervention is distinguished by the use of real-time Oxygen Reserve Index (ORI) monitoring to guide individualized intraoperative FiO₂ titration. Unlike fixed-FiO₂ strategies commonly used in anesthesia practice, this protocol continuously adjusts FiO₂ based on ORI values measured with the Masimo Rad-97 device. FiO₂ is increased or decreased in increments of 0.05 according to predefined ORI thresholds to maintain patients within a targeted normoxemic range. The intervention is entirely noninvasive and integrates standardized lung ultrasound (LUS) assessments and spirometry to evaluate postoperative aeration loss and respiratory function. This dynamic, physiology-based oxygen management approach differentiates the intervention from routine fixed-oxygen administration used in other clinical studies. | Procedure or surgery | Group 1-ORI-Guided FiO₂ Titration Group |
| Fixed oxygenAlso: fixed 50:50 oxygen and air combinationThis intervention uses a standard, non-individualized oxygen administration approach in which FiO₂ is maintained at a constant 50% throughout the entire surgical procedure. After preoxygenation with 80% FiO₂ for 3 minutes, the FiO₂ is set at 0.50 immediately after intubation and is not modified in response to patient physiology or ORI measurements. PEEP is fixed at 5 cmH₂O, and a standardized alveolar recruitment maneuver is applied at the beginning of surgery. This fixed-FiO₂ strategy differs from the ORI-guided titration group by avoiding dynamic oxygen adjustments and reflects conventional intraoperative oxygen management commonly used in clinical practice. | Procedure or surgery | Group 2- Fixed FiO₂ |
Primary outcome
Change in Total Lung Ultrasound (LUS) Score
Time frame: Baseline (Preoperative) and 30 Minutes After Extubation
The primary outcome of the study is the change in the total Lung Ultrasound (LUS) score obtained using a standardized 12-zone lung ultrasound protocol. Each hemithorax was evaluated in six regions-anterior, lateral, and posterior lines, each divided into superior and inferior zones-resulting in a total of 12 assessed areas. Each zone was scored from 0 to 3 based on the degree of aeration, yielding a total score ranging from 0 to 36, with higher scores indicating greater aeration loss and atelectasis. Accordingly, the difference between the preoperative LUS score and the LUS score measured at 30 minutes after extubation was defined as the primary endpoint of the study.
3 secondary outcomes
Change in Forced Vital Capacity (FVC)
Time frame: Baseline (Preoperative) and Postoperative 24th Hour
Change in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline (Preoperative) and Postoperative 24th Hour
Change in FEV1/FVC Ratio
Time frame: Baseline (Preoperative) and Postoperative 24th Hour
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 23 Oct 2026.
- 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.
Derya Özkan, Professor study director
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Titrated Oxygen and Fixed oxygen in people with Atelectases, Postoperative Pulmonary and Prone Position, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 11 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 23 Oct 2026. 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 Turkey (Türkiye). 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?
Change in Total Lung Ultrasound (LUS) Score (time frame: Baseline (Preoperative) and 30 Minutes After 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 23 Oct 2026.