AtelectasisNCT07758517
Fresh Gas Flow Rate and Perioperative Lung Aeration Assessed by Lung Ultrasound in Septoplasty
An observational study of Atelectasis and Nasal Septal Deviation, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective, single-center observational cohort study evaluated the association between fresh gas flow rate during inhalational anesthesia and perioperative changes in lung aeration in adults undergoing elective surgery for nasal septal deviation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atelectasis, Nasal Septal Deviation
- What is being tested?
- Fresh Gas Flow Rate of 1 L/min and Fresh Gas Flow Rate of 3 L/min
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2024to 15 Apr 2025
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of adults aged 18 to 65 years with American Society of Anesthesiologists physical status I or II who underwent elective septoplasty for nasal septal deviation under general anesthesia at Fatih Sultan Mehmet Training and Research Hospital. Eligible consenting participants were observed prospectively, and their perioperative clinical and lung ultrasound data were recorded. Fresh gas flow rates were selected by the attending anesthesiologist as part of routine clinical care.
Who may be able to join
- Adults aged 18 to 65 years
- Scheduled to undergo elective septoplasty for nasal septal deviation under general anesthesia
- American Society of Anesthesiologists physical status I or II
- Body mass index of 35 kg/m² or less
- Provided written informed consent to participate
Who cannot join
- Acute respiratory tract infection within the preceding 15 days
- Chronic pulmonary disease
- Malignancy
- Significant hepatic, renal, or cardiac disease
- Limited ability to cooperate with the study assessments
- Cerebrovascular or neuromuscular disease
Show all 10Show fewer
- Previous thoracic surgery
- Chest wall deformity
- Emergency surgery
- History of clinically relevant allergy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital
Istanbul, 34000
About this study
Official title: Evaluation of the Association Between Fresh Gas Flow Rate During Inhalational Anesthesia and Perioperative Pulmonary Aeration Assessed Using the Lung Ultrasound Score in Patients Undergoing Septoplasty: A Prospective Observational Study
This prospective, single-center observational cohort study evaluated the association between fresh gas flow rate during inhalational anesthesia and perioperative changes in lung aeration in adults undergoing elective surgery for nasal septal deviation.
Participants were classified into two cohorts according to the fresh gas flow rate used during routine anesthesia care: 1 L/min or 3 L/min. The flow rate was selected independently by the attending anesthesiologist as part of routine clinical practice and was not assigned by the research protocol.
Lung aeration was assessed using the modified lung ultrasound score before anesthesia, after tracheal intubation, before extubation, 15 minutes after admission to the post-anesthesia care unit, and before discharge from the post-anesthesia care unit. Perioperative oxygenation, hemodynamic variables, respiratory mechanics, and early postoperative recovery findings were also recorded.
Read the detailed description
This was a prospective, single-center observational cohort study conducted at Fatih Sultan Mehmet Training and Research Hospital. Adult patients aged 18 to 65 years with American Society of Anesthesiologists physical status I or II who underwent elective surgery for nasal septal deviation under general anesthesia were evaluated.
All participants provided written informed consent before enrollment. Anesthetic management was performed according to routine institutional clinical practice. The fresh gas flow rate was determined independently by the attending anesthesiologist and was not assigned or modified by the research protocol. Participants were subsequently classified into two observational cohorts according to the documented fresh gas flow rate used during inhalational anesthesia: 1 L/min or 3 L/min. No randomization was performed.
Lung ultrasound examinations were performed at five perioperative time points: before induction of anesthesia, after tracheal intubation, before extubation, 15 minutes after admission to the post-anesthesia care unit, and approximately 30 minutes after admission or immediately before discharge from the post-anesthesia care unit.
Lung aeration was evaluated in 12 thoracic regions using a modified lung ultrasound score. Each region was scored from 0 to 3 according to the observed ultrasound pattern. A score of 0 represented normal aeration, while scores of 1, 2, and 3 represented mild, moderate, and severe loss of aeration, respectively. The total score ranged from 0 to 36, with higher scores indicating greater loss of lung aeration.
The primary objective was to compare perioperative changes in the lung ultrasound score between patients receiving fresh gas flow rates of 1 L/min and 3 L/min during routine anesthesia. Additional recorded variables included heart rate, systolic, diastolic, and mean arterial pressure, peripheral oxygen saturation, perfusion index, end-tidal carbon dioxide, inspired and expired oxygen concentrations, body temperature, peak airway pressure, airway resistance, and dynamic lung compliance. Early postoperative findings, including pain intensity, nausea, vomiting, and shivering, were also evaluated in the post-anesthesia care unit.
- Conditions
- Atelectasis, Nasal Septal Deviation
- Being tested
- Fresh Gas Flow Rate of 1 L/min, Fresh Gas Flow Rate of 3 L/min
- Keywords
- Fresh gas flow rate, Low-flow anesthesia, Inhalational anesthesia, Lung ultrasound score, Lung ultrasound, Perioperative atelectasis, Pulmonary aeration, Septoplasty, Desflurane, Post-anesthesia care unit
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh Gas Flow Rate of 1 L/minOther
During routine inhalational general anesthesia, a fresh gas flow rate of 1 L/min was used. The flow rate was selected independently by the attending anesthesiologist according to routine clinical practice and was not assigned or modified by the research protocol. This exposure was evaluated in relation to perioperative changes in the modified lung ultrasound score.
Fresh Gas Flow Rate of 3 L/minOther
During routine inhalational general anesthesia, a fresh gas flow rate of 3 L/min was used. The flow rate was selected independently by the attending anesthesiologist according to routine clinical practice and was not assigned or modified by the research protocol. This exposure was evaluated in relation to perioperative changes in the modified lung ultrasound score.
| Study group | Role | What they receive |
|---|---|---|
| 1 L/min Fresh Gas Flow Cohort | Participants who received inhalational general anesthesia with a fresh gas flow rate of 1 L/min as part of routine anesthetic care. The fresh gas flow rate was selected independently by the attending anesthesiologist and was not assigned by the research protocol. Perioperative lung aeration was evaluated using the modified lung ultrasound score. Receives: Other: Fresh Gas Flow Rate of 1 L/min | |
| 3 L/min Fresh Gas Flow Cohort | Participants who received inhalational general anesthesia with a fresh gas flow rate of 3 L/min as part of routine anesthetic care. The fresh gas flow rate was selected independently by the attending anesthesiologist and was not assigned by the research protocol. Perioperative lung aeration was evaluated using the modified lung ultrasound score. Receives: Other: Fresh Gas Flow Rate of 3 L/min |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative Change in Modified Lung Ultrasound Score
Lung aeration was assessed in 12 thoracic regions, six regions in each hemithorax. Each region was scored from 0 to 3: 0 indicated normal aeration, 1 mild loss of aeration, 2 moderate loss of aeration, and 3 severe loss of aeration or consolidation. Regional scores were summed to obtain a total modified lung ultrasound score ranging from 0 to 36. Higher scores indicated greater loss of lung aeration. Changes in the total score across the perioperative time points were compared between the 1 L/min and 3 L/min fresh gas flow cohorts.
Measured: Preoperative baseline; after tracheal intubation; before extubation; 15 minutes after PACU admission; and approximately 30 minutes after PACU admission or before PACU discharge
Secondary outcomes (6)
Perioperative Peripheral Oxygen Saturation
Peripheral oxygen saturation (SpO2), expressed as a percentage, was measured using pulse oximetry. Values recorded at the prespecified perioperative time points were compared between the 1 L/min and 3 L/min fresh gas flow cohorts.
Measured: Preoperative baseline; after tracheal intubation; before extubation; 15 minutes after PACU admission; and approximately 30 minutes after PACU admission or before PACU discharge
Intraoperative Dynamic Lung Compliance
Dynamic lung compliance was obtained from the anesthesia machine and recorded in mL/cmH2O. Higher values indicated greater respiratory system compliance. Values were compared between the two fresh gas flow cohorts.
Measured: Approximately 5 minutes after tracheal intubation and immediately before extubation
Intraoperative Peak Airway Pressure
Peak airway pressure was obtained from the anesthesia machine and recorded in cmH2O during mechanical ventilation. Values were compared between the 1 L/min and 3 L/min fresh gas flow cohorts.
Measured: Approximately 5 minutes after tracheal intubation and immediately before extubation
Intraoperative Airway Resistance
Airway resistance was obtained from the anesthesia machine during mechanical ventilation and compared between the 1 L/min and 3 L/min fresh gas flow cohorts.
Measured: Approximately 5 minutes after tracheal intubation and immediately before extubation
Postoperative Pain Intensity
Postoperative pain intensity was assessed using a visual analog scale ranging from 0 to 10, where 0 indicated no pain and 10 indicated the worst imaginable pain.
Measured: At 15 minutes and approximately 30 minutes after admission to the PACU
Incidence of Nausea, Vomiting, and Shivering in the PACU
The occurrence of postoperative nausea, vomiting, and shivering was recorded as present or absent for each participant during recovery in the post-anesthesia care unit. Each event was evaluated separately as the number and percentage of participants experiencing the event.
Measured: From admission to the PACU until PACU discharge, approximately 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start10 Jan 2024
- Primary completion10 Jan 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtelectasisStudies 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oznur Demiroluk, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758517
- Sponsor's protocol ID
- FSM-LUS-2023
- Other IDs
- 2023/129
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Association Between Fresh Gas Flow Rate During Inhalational Anesthesia and Perioperative Pulmonary Aeration Assessed Using the Lung Ultrasound Score in Patients Undergoing Septoplasty: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07758517
- Acronym / sponsor ID
- FSM-LUS-2023
- Conditions
- Atelectasis, Nasal Septal Deviation
- Keywords
- Fresh gas flow rate, Low-flow anesthesia, Inhalational anesthesia, Lung ultrasound score, Lung ultrasound, Perioperative atelectasis, Pulmonary aeration, Septoplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 11 Aug 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.
This prospective, single-center observational cohort study evaluated the association between fresh gas flow rate during inhalational anesthesia and perioperative changes in lung aeration in adults undergoing elective surgery for nasal septal deviation.
Participants were classified into two cohorts according to the fresh gas flow rate used during routine anesthesia care: 1 L/min or 3 L/min. The flow rate was selected independently by the attending anesthesiologist as part of routine clinical practice and was not assigned by the research protocol.
Lung aeration was assessed using the modified lung ultrasound score before anesthesia, after tracheal intubation, before extubation, 15 minutes after admission to the post-anesthesia care unit, and before discharge from the post-anesthesia care unit. Perioperative oxygenation, hemodynamic variables, respiratory mechanics, and early postoperative recovery findings were also recorded.
Detailed description
This was a prospective, single-center observational cohort study conducted at Fatih Sultan Mehmet Training and Research Hospital. Adult patients aged 18 to 65 years with American Society of Anesthesiologists physical status I or II who underwent elective surgery for nasal septal deviation under general anesthesia were evaluated.
All participants provided written informed consent before enrollment. Anesthetic management was performed according to routine institutional clinical practice. The fresh gas flow rate was determined independently by the attending anesthesiologist and was not assigned or modified by the research protocol. Participants were subsequently classified into two observational cohorts according to the documented fresh gas flow rate used during inhalational anesthesia: 1 L/min or 3 L/min. No randomization was performed.
Lung ultrasound examinations were performed at five perioperative time points: before induction of anesthesia, after tracheal intubation, before extubation, 15 minutes after admission to the post-anesthesia care unit, and approximately 30 minutes after admission or immediately before discharge from the post-anesthesia care unit.
Lung aeration was evaluated in 12 thoracic regions using a modified lung ultrasound score. Each region was scored from 0 to 3 according to the observed ultrasound pattern. A score of 0 represented normal aeration, while scores of 1, 2, and 3 represented mild, moderate, and severe loss of aeration, respectively. The total score ranged from 0 to 36, with higher scores indicating greater loss of lung aeration.
The primary objective was to compare perioperative changes in the lung ultrasound score between patients receiving fresh gas flow rates of 1 L/min and 3 L/min during routine anesthesia. Additional recorded variables included heart rate, systolic, diastolic, and mean arterial pressure, peripheral oxygen saturation, perfusion index, end-tidal carbon dioxide, inspired and expired oxygen concentrations, body temperature, peak airway pressure, airway resistance, and dynamic lung compliance. Early postoperative findings, including pain intensity, nausea, vomiting, and shivering, were also evaluated in the post-anesthesia care unit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 L/min Fresh Gas Flow Cohort | – | Other: Fresh Gas Flow Rate of 1 L/minParticipants who received inhalational general anesthesia with a fresh gas flow rate of 1 L/min as part of routine anesthetic care. The fresh gas flow rate was selected independently by the attending anesthesiologist and was not assigned by the research protocol. Perioperative lung aeration was evaluated using the modified lung ultrasound score. |
| 3 L/min Fresh Gas Flow Cohort | – | Other: Fresh Gas Flow Rate of 3 L/minParticipants who received inhalational general anesthesia with a fresh gas flow rate of 3 L/min as part of routine anesthetic care. The fresh gas flow rate was selected independently by the attending anesthesiologist and was not assigned by the research protocol. Perioperative lung aeration was evaluated using the modified lung ultrasound score. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of adults aged 18 to 65 years with American Society of Anesthesiologists physical status I or II who underwent elective septoplasty for nasal septal deviation under general anesthesia at Fatih Sultan Mehmet Training and Research Hospital. Eligible consenting participants were observed prospectively, and their perioperative clinical and lung ultrasound data were recorded. Fresh gas flow rates were selected by the attending anesthesiologist as part of routine clinical care.
Key inclusion criteria (5 listed)
- Adults aged 18 to 65 years
- Scheduled to undergo elective septoplasty for nasal septal deviation under general anesthesia
- American Society of Anesthesiologists physical status I or II
- Body mass index of 35 kg/m² or less
- Provided written informed consent to participate
Key exclusion criteria (10 listed)
- Acute respiratory tract infection within the preceding 15 days
- Chronic pulmonary disease
- Malignancy
- Significant hepatic, renal, or cardiac disease
- Limited ability to cooperate with the study assessments
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 |
|---|---|---|
| Fresh Gas Flow Rate of 1 L/minDuring routine inhalational general anesthesia, a fresh gas flow rate of 1 L/min was used. The flow rate was selected independently by the attending anesthesiologist according to routine clinical practice and was not assigned or modified by the research protocol. This exposure was evaluated in relation to perioperative changes in the modified lung ultrasound score. | Other | 1 L/min Fresh Gas Flow Cohort |
| Fresh Gas Flow Rate of 3 L/minDuring routine inhalational general anesthesia, a fresh gas flow rate of 3 L/min was used. The flow rate was selected independently by the attending anesthesiologist according to routine clinical practice and was not assigned or modified by the research protocol. This exposure was evaluated in relation to perioperative changes in the modified lung ultrasound score. | Other | 3 L/min Fresh Gas Flow Cohort |
Primary outcome
Perioperative Change in Modified Lung Ultrasound Score
Time frame: Preoperative baseline; after tracheal intubation; before extubation; 15 minutes after PACU admission; and approximately 30 minutes after PACU admission or before PACU discharge
Lung aeration was assessed in 12 thoracic regions, six regions in each hemithorax. Each region was scored from 0 to 3: 0 indicated normal aeration, 1 mild loss of aeration, 2 moderate loss of aeration, and 3 severe loss of aeration or consolidation. Regional scores were summed to obtain a total modified lung ultrasound score ranging from 0 to 36. Higher scores indicated greater loss of lung aeration. Changes in the total score across the perioperative time points were compared between the 1 L/min and 3 L/min fresh gas flow cohorts.
6 secondary outcomes
Perioperative Peripheral Oxygen Saturation
Time frame: Preoperative baseline; after tracheal intubation; before extubation; 15 minutes after PACU admission; and approximately 30 minutes after PACU admission or before PACU discharge
Intraoperative Dynamic Lung Compliance
Time frame: Approximately 5 minutes after tracheal intubation and immediately before extubation
Intraoperative Peak Airway Pressure
Time frame: Approximately 5 minutes after tracheal intubation and immediately before extubation
Intraoperative Airway Resistance
Time frame: Approximately 5 minutes after tracheal intubation and immediately before extubation
Postoperative Pain Intensity
Time frame: At 15 minutes and approximately 30 minutes after admission to the PACU
Incidence of Nausea, Vomiting, and Shivering in the PACU
Time frame: From admission to the PACU until PACU discharge, approximately 30 minutes
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 11 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Atelectasis and Nasal Septal Deviation, run by Fatih Sultan Mehmet Training and Research 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 5 inclusion and 10 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 11 Aug 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?
Perioperative Change in Modified Lung Ultrasound Score (time frame: Preoperative baseline; after tracheal intubation; before extubation; 15 minutes after PACU admission; and approximately 30 minutes after PACU admission or before PACU discharge). 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 11 Aug 2026.