ASA Class I/II PatientsNCT07305129
PCV vs VCV in Low-Flow Anesthesia
An observational study of ASA Class I/II Patients and General Anesthetic, run by HULYA TOPCU, MD at 1 site in Turkey (Türkiye).
Trial summary
The aim of this observational study is to investigate the effects of ventilation modes on intraoperative and postoperative lung functions in patients under general anesthesia. This study aimed to compare the effects of low-flow anesthesia on intraoperative respiratory mechanics and early postoperative pulmonary… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- ASA Class I/II Patients, General Anesthetic, Low Flow Anesthesia
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Aug 2023to 3 Dec 2023
- 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: Hitit University Erol Olçok Training and Research Hospital
Who may be able to join
- age 18-65 years and American Society of Anesthesiologists (ASA) physical status I-II.
Who cannot join
- morbid obesity (BMI > 35 kg/m²),
- scoliosis or thoracic deformity,
- restrictive or obstructive lung disease,
- prior thoracic or upper abdominal surgery,
- history of major thoracic trauma or congenital chest wall anomaly,
- active smoking or chronic use of corticosteroids,
Show all 9Show fewer
- β-agonists, bronchodilators, or antihistamines,
- anticipated difficult airway
- severe hypoxemia (SpO₂ < 90%) during induction.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hitit University Erol Olçok Training and Research Hospital
Çorum, Çorum, 19030
About this study
Official title: Pressure-Controlled Versus Volume-Controlled Ventilation in Low-Flow Anesthesia: A Randomized Controlled Trial on Intraoperative Respiratory Mechanics and Postoperative Pulmonary Function
The aim of this observational study is to investigate the effects of ventilation modes on intraoperative and postoperative lung functions in patients under general anesthesia.
This study aimed to compare the effects of low-flow anesthesia on intraoperative respiratory mechanics and early postoperative pulmonary function between PCV and VCV in ASA I-II adult patients.
Read the detailed description
Studies comparing the effects of pressure-controlled ventilation (PCV) and volume-controlled ventilation (VCV) on lung function under low-flow conditions are limited. In this study, the effects of PCV and VCV on intraoperative respiratory mechanics and early postoperative pulmonary function were investigated during low-flow anesthesia in ASA I-II adult patients undergoing routine anesthesia procedures.
- Keywords
- low-flow anesthesia, pressure-controlled ventilation, volume-controlled ventilation, respiratory mechanics, peak inspiratory pressure, pulmonary function
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Ppeak (cmH₂O) at each time point; between-group difference.
Peak inspiratory pressure will be measured using the anesthesia workstation's built-in pressure monitoring system. Ppeak (cmH₂O) values will be automatically recorded at predefined time points: baseline after intubation, before low-flow transition, and 5, 10, 15, and 30 minutes after transition to low-flow anesthesia. Group comparisons will be reported as mean ± SD and analyzed for intergroup differences.
Measured: From post-intubation baseline until 30 minutes after initiation of low-flow anesthesia (approximately 45 minutes total).
Secondary outcomes (1)
Change in inspiratory score (number of balls raised).
Mean airway pressure will be measured continuously by the anesthesia machine. Values will be recorded at the same predefined time points as Ppeak. Data will be reported as mean ± SD. Dynamic compliance (mL/cmH₂O) will be calculated using the ventilator's automated measurement system (tidal volume / (Ppeak - PEEP)). Values will be recorded at identical intraoperative time points. Data will be reported as mean ± SD. Inspiratory effort will be assessed using the Triflo incentive spirometer by recording the number of balls elevated on a single maximal inspiratory attempt (range: 0-3). Measurements will be taken preoperatively and 1 hour postoperatively in the recovery unit.
Measured: Baseline to 30 minutes after initiation of low-flow anesthesia and Preoperative baseline and postoperative 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start6 Aug 2023
- Primary completion3 Dec 2023
- Study completion3 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASA Class I/II PatientsStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- HULYA TOPCU, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, HULYA TOPCU, MD, Erol Olcok Corum Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305129
- Sponsor's protocol ID
- 2023-64
- Other IDs
- hulya topcu, serhat ozciftci
- Status last verified
- Sep 2026
- First submitted
- 27 Nov 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure-Controlled Versus Volume-Controlled Ventilation in Low-Flow Anesthesia: A Randomized Controlled Trial on Intraoperative Respiratory Mechanics and Postoperative Pulmonary Function
- ClinicalTrials.gov ID
- NCT07305129
- Acronym / sponsor ID
- 2023-64
- Keywords
- low-flow anesthesia, pressure-controlled ventilation, volume-controlled ventilation, respiratory mechanics, peak inspiratory pressure, pulmonary function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- HULYA TOPCU, MDUniversity, hospital or other
- Study start
- 6 Aug 2023 (actual)
- Primary completion
- 3 Dec 2023 (actual)
- Study completion
- 3 Dec 2023 (actual)
- First posted
- 26 Dec 2025 (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.
The aim of this observational study is to investigate the effects of ventilation modes on intraoperative and postoperative lung functions in patients under general anesthesia.
This study aimed to compare the effects of low-flow anesthesia on intraoperative respiratory mechanics and early postoperative pulmonary function between PCV and VCV in ASA I-II adult patients.
Detailed description
Studies comparing the effects of pressure-controlled ventilation (PCV) and volume-controlled ventilation (VCV) on lung function under low-flow conditions are limited. In this study, the effects of PCV and VCV on intraoperative respiratory mechanics and early postoperative pulmonary function were investigated during low-flow anesthesia in ASA I-II adult patients undergoing routine anesthesia procedures.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hitit University Erol Olçok Training and Research Hospital
Key inclusion criteria (1 listed)
- age 18-65 years and American Society of Anesthesiologists (ASA) physical status I-II.
Key exclusion criteria (9 listed)
- morbid obesity (BMI > 35 kg/m²),
- scoliosis or thoracic deformity,
- restrictive or obstructive lung disease,
- prior thoracic or upper abdominal surgery,
- history of major thoracic trauma or congenital chest wall anomaly,
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
Mean Ppeak (cmH₂O) at each time point; between-group difference.
Time frame: From post-intubation baseline until 30 minutes after initiation of low-flow anesthesia (approximately 45 minutes total).
Peak inspiratory pressure will be measured using the anesthesia workstation's built-in pressure monitoring system. Ppeak (cmH₂O) values will be automatically recorded at predefined time points: baseline after intubation, before low-flow transition, and 5, 10, 15, and 30 minutes after transition to low-flow anesthesia. Group comparisons will be reported as mean ± SD and analyzed for intergroup differences.
1 secondary outcome
Change in inspiratory score (number of balls raised).
Time frame: Baseline to 30 minutes after initiation of low-flow anesthesia and Preoperative baseline and postoperative 1 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 10 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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 ASA Class I/II Patients and General Anesthetic, run by HULYA TOPCU, MD 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 1 inclusion and 9 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 10 Sep 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?
Mean Ppeak (cmH₂O) at each time point; between-group difference. (time frame: From post-intubation baseline until 30 minutes after initiation of low-flow anesthesia (approximately 45 minutes total).). 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 10 Sep 2026.