Postoperative Respiratory ComplicationPPETNCT07251686
Positive-Pressure vs Suction Extubation in Cesarean Patients
A study testing Negative Pressure Extubation Technique (NPET) and Positive Pressure Extubation Technique (PPET) in people with Postoperative Respiratory Complication and Atelectasis, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the effects of two tracheal extubation techniques on postoperative oxygenation and early respiratory outcomes in adult women undergoing elective cesarean delivery under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postoperative Respiratory Complication, Atelectasis, Anesthesia, General
- What is being tested?
- Negative Pressure Extubation Technique (NPET) and Positive Pressure Extubation Technique (PPET)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 10 Nov 2025
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Adult female patients aged 18 to 45 years.
- Scheduled for elective cesarean delivery under general anesthesia.
- Ability to provide written informed consent
Who cannot join
- Exclusion criteria included patients participating in another study,
- Patients refusing to participate,
- Uncooperative patients,
- Patients undergoing emergency surgery,
- American Society of Anesthesiologists (ASA) Physical Status Classification > 3,
- Patients with chronic respiratory failure, obstructive sleep apnea, and patients with anticipated difficult airways.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol Mega University Hospital
Istanbul, Bagcılar
About this study
Official title: Impact of Extubation Technique on Postoperative Pulmonary Outcomes: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effects of two tracheal extubation techniques on postoperative oxygenation and early respiratory outcomes in adult women undergoing elective cesarean delivery under general anesthesia. A total of 120 participants will be randomly assigned to the Positive Pressure Extubation Technique (PPET) group or the Negative Pressure Extubation Technique (NPET) group.
In the PPET group, extubation will be performed while maintaining positive airway pressure during cuff deflation, whereas in the NPET group, extubation will be performed under continuous suction. The primary outcome will be the incidence of postoperative desaturation, defined as peripheral oxygen saturation (SpO₂) below 92% within the first 60 minutes after extubation.
Secondary outcomes will include serial measurements of oxygen saturation, heart rate, and blood pressure, along with exploratory analyses assessing the relationship between body mass index, comorbidities, and desaturation risk. The trial is intended to determine whether PPET provides physiological advantages over NPET during tracheal extubation in this surgical population.
Read the detailed description
Extubation represents a vulnerable phase of general anesthesia, during which airway secretions, reduced functional residual capacity, and diminished upper airway tone may contribute to hypoxemia and other respiratory complications. Pregnant women are particularly susceptible due to decreased lung volumes, increased oxygen consumption, and airway edema associated with pregnancy.
The Positive-Pressure Extubation Technique (PPET) has been proposed as a strategy to reduce the migration of secretions toward the distal airways during cuff deflation, potentially improving lung aeration and gas exchange. Unlike conventional suction-based methods, PPET uses continuous positive pressure to maintain airflow direction, theoretically minimizing micro-aspiration and early atelectasis formation.
Although PPET has demonstrated benefits in pediatric and mixed surgical populations, evidence regarding its application in obstetric anesthesia remains scarce. This study aims to evaluate whether positive-pressure extubation provides physiological advantages over conventional negative-pressure extubation in adult patients undergoing cesarean delivery under general anesthesia. By examining postoperative respiratory stability and hemodynamic responses, the study is expected to clarify the clinical importance of tailored extubation strategies in populations with reduced pulmonary reserve.
- Conditions
- Postoperative Respiratory Complication, Atelectasis, Anesthesia, General, Extubation, Hypoxia
- Being tested
- Negative Pressure Extubation Technique (NPET), Positive Pressure Extubation Technique (PPET)
- Keywords
- Postoperative Respiratory Complication, Positive pressure, Extubation, Cesarean Section, Anesthesia, Hypoxia
- Medical subject headings
- Pulmonary Atelectasis, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure Extubation Technique (NPET)Procedure or surgery
Extubation performed under continuous suction during cuff deflation.
Positive Pressure Extubation Technique (PPET)Procedure or surgery
Extubation performed under continuous positive airway pressure during cuff deflation (PEEP 6 cmH₂O, PS 12 cmH₂O)
| Study group | Role | What they receive |
|---|---|---|
| Positive-Pressure Extubation (PPET) | Experimental | Extubation was performed under continuous positive airway pressure (PEEP 6 cmH₂O, PS 12 cmH₂O) during cuff deflation. Receives: Procedure: Positive Pressure Extubation Technique (PPET) |
| Negative-Pressure Extubation (NPET) | Active comparator | Extubation was performed under continuous suction during cuff deflation, representing the conventional technique. Receives: Procedure: Negative Pressure Extubation Technique (NPET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative desaturation (SpO₂ < 92%)
The proportion of participants who experience oxygen desaturation, defined as peripheral oxygen saturation (SpO₂) below 92%, at any time point within the first 60 minutes after extubation.
Measured: Within the first 60 minutes after extubation
Secondary outcomes (3)
Change in Peripheral Oxygen Saturation (SpO₂)
SpO₂ values measured at predefined intervals (1, 3, 5, 10, 15, 30, and 60 minutes) after extubation.
Measured: 0-60 minutes post-extubation
Change in Heart Rate
Heart rate measurements recorded at predefined intervals after extubation.
Measured: 0-60 minutes post-extubation
Change in Systolic and Diastolic Blood Pressure
Systolic and diastolic blood pressure were recorded at predefined intervals after extubation.
Measured: 0-60 minutes post-extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Sep 2025
- Primary completion10 Nov 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Respiratory ComplicationStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NURDAN YILMAZ, Medipol University
- Investigators
- NURDAN YILMAZ, Principal investigator, Istanbul Medipol Mega University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251686
- Sponsor's protocol ID
- PPETRCT2024
- Other IDs
- Medipol University Ethics
- Acronym
- PPET
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to patient confidentiality and institutional policy. Summary data will be available upon reasonable request from the corresponding author.
Publications
Yilmaz N, Gul YG. Positive-Pressure Extubation Improves Early Oxygenation but Not Desaturation After Cesarean Delivery Under General Anesthesia: A Randomized Controlled Trial. Healthcare (Basel). 2026 Jul 4;14(13):1991. doi: 10.3390/healthcare14131991.
PubMed 42451001
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Extubation Technique on Postoperative Pulmonary Outcomes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07251686
- Acronym / sponsor ID
- PPET / PPETRCT2024
- Conditions
- Postoperative Respiratory Complication, Atelectasis, Anesthesia, General, Extubation, Hypoxia
- Keywords
- Postoperative Respiratory Complication, Positive pressure, Extubation, Cesarean Section, Anesthesia, Hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 26 Nov 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.
This randomized controlled trial aims to evaluate the effects of two tracheal extubation techniques on postoperative oxygenation and early respiratory outcomes in adult women undergoing elective cesarean delivery under general anesthesia. A total of 120 participants will be randomly assigned to the Positive Pressure Extubation Technique (PPET) group or the Negative Pressure Extubation Technique (NPET) group.
In the PPET group, extubation will be performed while maintaining positive airway pressure during cuff deflation, whereas in the NPET group, extubation will be performed under continuous suction. The primary outcome will be the incidence of postoperative desaturation, defined as peripheral oxygen saturation (SpO₂) below 92% within the first 60 minutes after extubation.
Secondary outcomes will include serial measurements of oxygen saturation, heart rate, and blood pressure, along with exploratory analyses assessing the relationship between body mass index, comorbidities, and desaturation risk. The trial is intended to determine whether PPET provides physiological advantages over NPET during tracheal extubation in this surgical population.
Detailed description
Extubation represents a vulnerable phase of general anesthesia, during which airway secretions, reduced functional residual capacity, and diminished upper airway tone may contribute to hypoxemia and other respiratory complications. Pregnant women are particularly susceptible due to decreased lung volumes, increased oxygen consumption, and airway edema associated with pregnancy.
The Positive-Pressure Extubation Technique (PPET) has been proposed as a strategy to reduce the migration of secretions toward the distal airways during cuff deflation, potentially improving lung aeration and gas exchange. Unlike conventional suction-based methods, PPET uses continuous positive pressure to maintain airflow direction, theoretically minimizing micro-aspiration and early atelectasis formation.
Although PPET has demonstrated benefits in pediatric and mixed surgical populations, evidence regarding its application in obstetric anesthesia remains scarce. This study aims to evaluate whether positive-pressure extubation provides physiological advantages over conventional negative-pressure extubation in adult patients undergoing cesarean delivery under general anesthesia. By examining postoperative respiratory stability and hemodynamic responses, the study is expected to clarify the clinical importance of tailored extubation strategies in populations with reduced pulmonary reserve.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive-Pressure Extubation (PPET) | Experimental | Procedure: Positive Pressure Extubation Technique (PPET)Extubation was performed under continuous positive airway pressure (PEEP 6 cmH₂O, PS 12 cmH₂O) during cuff deflation. |
| Negative-Pressure Extubation (NPET) | Active comparator | Procedure: Negative Pressure Extubation Technique (NPET)Extubation was performed under continuous suction during cuff deflation, representing the conventional technique. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult female patients aged 18 to 45 years.
- Scheduled for elective cesarean delivery under general anesthesia.
- Ability to provide written informed consent
Key exclusion criteria (6 listed)
- Exclusion criteria included patients participating in another study,
- Patients refusing to participate,
- Uncooperative patients,
- Patients undergoing emergency surgery,
- American Society of Anesthesiologists (ASA) Physical Status Classification > 3,
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 |
|---|---|---|
| Negative Pressure Extubation Technique (NPET)Extubation performed under continuous suction during cuff deflation. | Procedure or surgery | Negative-Pressure Extubation (NPET) |
| Positive Pressure Extubation Technique (PPET)Extubation performed under continuous positive airway pressure during cuff deflation (PEEP 6 cmH₂O, PS 12 cmH₂O) | Procedure or surgery | Positive-Pressure Extubation (PPET) |
Primary outcome
Incidence of postoperative desaturation (SpO₂ < 92%)
Time frame: Within the first 60 minutes after extubation
The proportion of participants who experience oxygen desaturation, defined as peripheral oxygen saturation (SpO₂) below 92%, at any time point within the first 60 minutes after extubation.
3 secondary outcomes
Change in Peripheral Oxygen Saturation (SpO₂)
Time frame: 0-60 minutes post-extubation
Change in Heart Rate
Time frame: 0-60 minutes post-extubation
Change in Systolic and Diastolic Blood Pressure
Time frame: 0-60 minutes post-extubation
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 4 Dec 2025.
- Derived from this study: PubMed 42451001Yilmaz N, Gul YG. Positive-Pressure Extubation Improves Early Oxygenation but Not Desaturation After Cesarean Delivery Under General Anesthesia: A Randomized Controlled Trial. Healthcare (Basel). 2026 Jul 4;14(13):1991. doi: 10.3390/healthcare14131991.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to patient confidentiality and institutional policy. Summary data will be available upon reasonable request from the corresponding author.
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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.
NURDAN YILMAZ principal investigator
Istanbul Medipol Mega University 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 Negative Pressure Extubation Technique (NPET) and Positive Pressure Extubation Technique (PPET) in people with Postoperative Respiratory Complication and Atelectasis, run by Medipol University 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 6 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 4 Dec 2025. 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?
Incidence of postoperative desaturation (SpO₂ < 92%) (time frame: Within the first 60 minutes after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07251686, which also lists 1 linked publication.
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 4 Dec 2025.