Positive Pressure Extubation TechniquesNCT07829627
Positive- vs Negative-Pressure Extubation in High-Risk Patients
A study testing Positive-pressure extubation and Negative-pressure extubation in people with Positive Pressure Extubation Techniques and Negative Pressure Extubation Techniques, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
In the intensive care unit (ICU), weaning from mechanical ventilation and extubation are critical clinical goals. Successful extubation not only significantly shortens mechanical ventilation duration but also reduces the incidence of complications such as ventilator-associated pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Positive Pressure Extubation Techniques, Negative Pressure Extubation Techniques, High-risk Patients Prone to Extubation Failure
- What is being tested?
- Positive-pressure extubation and Negative-pressure extubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2026to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥ 18 years undergoing MV for ≥ 24 h
- Patients meeting at least one of the criteria for increased risk of extubation failure
- Patients meeting weaning criteria
- Patients or their families agree to participate in this trial and sign an informed consent form
Who cannot join
- General exclusion criteria:
- Do-not-resuscitate orders
- Preference for a specific weaning strategy by the physician in charge
- Mental incapacity without legal representatio
- Specific exclusion criteria for ultrasound:
- Inadequate ultrasound window (subcutaneous emphysema, lung bullae, large or thick bandages, pneumothorax, etc
Show all 16Show fewer
- severe bleeding tendency
- recent severe hemoptysis, dyspnea, severe cough or patient unable to cooperate.
- Specific exclusion criteria for EIT:
- pacemaker or implanted defibrillator
- local skin infection or open wound in the chest area where the electrode band is attached to the skin
- unstable spinal injury or fracture
- Withdrawal criteria:
- the subjects or their family requesting to withdraw informed consent
- The trial being unable to proceed normally due to changes in the patient's own condition or personnel operations
- During the research, patients are escalated with respiratory support using non-invasive ventilation or high-flow oxygen therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032
Kai Liu, Bachelor of Science, 13513146346, liu.kai1@zs-hospital.sh.cn
About this study
Official title: A Comparison of the Physiological Effects of Positive Pressure and Negative Pressure Techniques on High-risk Patients With Extubation Failure: a Single-center Randomized Controlled Study
In the intensive care unit (ICU), weaning from mechanical ventilation and extubation are critical clinical goals. Successful extubation not only significantly shortens mechanical ventilation duration but also reduces the incidence of complications such as ventilator-associated pneumonia. However, extubation failure rates remain high, especially in high-risk patient populations. Even after passing the Spontaneous Breathing Trial (SBT), 10%-25% of high-risk patients experience respiratory deterioration post-extubation, necessitating reintubation. Therefore, optimizing extubation strategies for high-risk patients is essential.
Currently, extubation techniques in clinical practice are primarily classified into negative pressure extubation and positive pressure extubation. Traditional negative pressure extubation involves continuous tracheal suction to clear secretions; however, this negative pressure can lead to alveolar collapse, regional ventilation mismatch, and an increased risk of aspiration. In contrast, positive pressure extubation maintains airway pressure (such as pressure support or positive end expiratory pressure), which theoretically facilitates the movement of subglottic secretions toward the oropharynx, while also promoting alveolar recruitment and improving ventilation/perfusion matching. Although randomized controlled trials have explored the safety of these two techniques, the conclusions remain controversial. Some studies suggest that positive pressure extubation reduces post-extubation hypoxemia and reintubation rates, while a meta-analysis indicates no statistically significant difference in overall complication rates between the two methods. This discrepancy may arise from heterogeneity in study populations, inadequate standardization of operational parameters, and the limited sensitivity of traditional monitoring methods in detecting regional pulmonary dynamic changes.
Read more
In recent years, Electrical Impedance Tomography (EIT) and Lung Ultrasound (LUS) have emerged as non-invasive bedside monitoring technologies, offering new insights into the physiological effects of extubation. EIT enables real-time dynamic imaging to quantitatively map both whole-lung and regional ventilation distributions, allowing for the sensitive detection of alveolar collapse or over-expansion. LUS, utilizing its B-line scoring system, provides an objective assessment of lung ventilation loss with high sensitivity and specificity. The combined use of these two techniques not only reveals the effects of extubation on overall oxygenation but also facilitates a detailed analysis of regional ventilation heterogeneity and compensatory mechanisms, thereby offering multimodal data to optimize extubation strategies.
This study proposes the design of a single-center, prospective, randomized controlled trial to systematically assess the physiological differences between positive pressure and negative pressure extubation techniques in high-risk patients prone to extubation failure. The goal is to provide evidence-based support for developing individualized extubation strategies tailored to high-risk patients.
Read the detailed description
Patients meeting at least one of the criteria for increased risk of extubation failure: be over 65 years of age or have any underlying chronic cardiac or pulmonary disease. Underlying chronic cardiac disease includes left ventricular dysfunction (left ventricular ejection fraction equal to or less than 45%); history of cardiogenic pulmonary edema; ischemic heart disease or persistent atrial fibrillation; underlying chronic lung disease including chronic obstructive pulmonary disease, obesity-hypopnea syndrome, or restrictive lung disease.
Patients meeting weaning criteria: resolution or improvement of the pathology that motivated intubation, clinical stability (heart rate (HR) < 140 bpm, systolic blood pressure (BP) 90-160 mmHg without vasopressors or at minimum doses); pass the spontaneous breathing trail (SBT): The ventilator was in pressure support mode, with a pressure support of 8 cmH20 and a positive end-expiratory pressure of 5 cmH20 for 30 min. SBT success criteria: respiratory rate/tidal volume ratio <105, respiratory rate >8 times/min or <35 times/min, spontaneous tidal volume >4 mL/kg, arterial oxygen saturation >0.90, arterial blood gas analysis pH value >7.35, Pa02/Fi02 >150 mmHg; adequate mentation (no sedation or adequate mentation on sedation, Glasgow Coma Scale (GCS) > 13) Electrical impedance tomography (EIT) is a noninvasive bedside imaging technique that allows real-time assessment of global and regional lung ventilation. It provides dynamic information on changes in tidal volume distribution and lung aeration, which may help to better understand the physiological effects of different extubation techniques.
This single-center randomized controlled study aims to compare the physiological effects of positive-pressure and negative-pressure extubation in adult patients at high risk of extubation failure. Patients will be randomly assigned to one of the two extubation techniques. Lung ventilation will be assessed using EIT before and after extubation. Extubation-related complications and changes in oxygenation parameters will also be recorded. The results of this study are expected to provide evidence to guide the selection of extubation techniques in high-risk patients.
- Conditions
- Positive Pressure Extubation Techniques, Negative Pressure Extubation Techniques, High-risk Patients Prone to Extubation Failure
- Being tested
- Positive-pressure extubation, Negative-pressure extubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive-pressure extubationProcedure or surgery
Positive pressure technique：the ventilator will be not disconnected. In the original SBT mode, the patient will be instructed to inhale forcefully. When the patient reached the peak inspiratory flow rate, the cuff will be deflated and the endotracheal tube will be removed without endotracheal suction. Once the endotracheal tube is removed, a suction tube is used to aspirate oropharyngeal secretions.
Negative-pressure extubationProcedure or surgery
Negative pressure technique: disconnect the ventilator, insert the suction tube into the endotracheal tube and pass it over the distal opening, perform continuous negative pressure suction in the trachea, and at the same time evacuate the cuff of the endotracheal tube, and remove the suction tube and the catheter together.
| Study group | Role | What they receive |
|---|---|---|
| Positive-pressure extubation | Experimental | the ventilator will be not disconnected. In the original SBT mode, the patient will be instructed to inhale forcefully. When the patient reached the peak inspiratory flow rate, the cuff will be deflated and the endotracheal tube will be removed without endotracheal suction. Once the endotracheal tube is removed, a suction tube is used to aspirate oropharyngeal secretions. Receives: Procedure: Positive-pressure extubation |
| Negative-pressure extubation | Experimental | disconnect the ventilator, insert the suction tube into the endotracheal tube and pass it over the distal opening, perform continuous negative pressure suction in the trachea, and at the same time evacuate the cuff of the endotracheal tube, and remove the suction tube and the catheter together. Receives: Procedure: Negative-pressure extubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is percentage of ROI3 and ROI4 measured by EIT monitoring
Measured: Baseline (before spontaneous breathing test), immediately before extubation, 30 minutes after extubation, 2 hours after extubation, and 6 hours after extubation.
Secondary outcomes (4)
Regional Ventilation Delay (RVD) measured by Electrical Impedance Tomography (EIT)
Measured: Baseline (before spontaneous breathing test), immediately before extubation, 30 minutes after extubation, 2 hours after extubation, and 6 hours after extubation.
Global Inhomogeneity Index (GI) measured by Electrical Impedance Tomography (EIT)
Measured: Baseline (before spontaneous breathing test), immediately before extubation, 30 minutes after extubation, 2 hours after extubation, and 6 hours after extubation.
Center of Ventilation (COV) measured by Electrical Impedance Tomography (EIT)
Measured: Baseline (before spontaneous breathing test), immediately before extubation, 30 minutes after extubation, 2 hours after extubation, and 6 hours after extubation.
End-Expiratory Lung Volume (EELV) measured by Electrical Impedance Tomography (EIT)
Measured: Baseline (before spontaneous breathing test), immediately before extubation, 30 minutes after extubation, 2 hours after extubation, and 6 hours after extubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Positive Pressure Extubation TechniquesStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829627
- Sponsor's protocol ID
- B2025-743R
- Status last verified
- Sep 2026
- First submitted
- 7 Jun 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the data contain potentially identifiable information, and data sharing is not covered by the current informed consent and ethics approval.
Publications
Andreu MF, Salvati IG, Donnianni MC, Ibanez B, Cotignola M, Bezzi M. Effect of applying positive pressure with or without endotracheal suctioning during extubation: a laboratory study. Respir Care. 2014 Dec;59(12):1905-11. doi: 10.4187/respcare.03121. Epub 2014 Nov 25.
PubMed 25425709Joussellin V, Bonny V, Spadaro S, Clerc S, Parfait M, Ferioli M, Sieye A, Jalil Y, Janiak V, Pinna A, Dres M. Lung aeration estimated by chest electrical impedance tomography and lung ultrasound during extubation. Ann Intensive Care. 2023 Sep 26;13(1):91. doi: 10.1186/s13613-023-01180-3.
PubMed 37752365Shimada K, Inokuchi R, Iwagami M, Tanaka M, Tamiya N. Comparison of Postextubation Complications Between Positive-Pressure and Suctioning Techniques: A Systematic Review. Respir Care. 2023 Mar;68(3):429-436. doi: 10.4187/respcare.10326.
PubMed 36828583Liu S, Ye Z, Zou H, Mei C, Hu Z, Xu W. [Comparison of positive and negative pressure extubation after mechanical ventilation in intensive care unit patients]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2022 Mar;34(3):265-268. doi: 10.3760/cma.j.cn121430-20211022-01545. Chinese.
PubMed 35574743Shimada K, Gosho M, Ohigashi T, Kume K, Yano T, Ishii R, Maruo K, Inokuchi R, Iwagami M, Ueda H, Tanaka M, Sanuki M, Tamiya N. Risk of postoperative pneumonia after extubation with the positive pressure versus normal pressure technique: a single-center retrospective observational study. J Anesth. 2025 Feb;39(1):5-14. doi: 10.1007/s00540-024-03409-2. Epub 2024 Sep 12.
PubMed 39283488
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Physiological Effects of Positive Pressure and Negative Pressure Techniques on High-risk Patients With Extubation Failure: a Single-center Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07829627
- Acronym / sponsor ID
- B2025-743R
- Conditions
- Positive Pressure Extubation Techniques, Negative Pressure Extubation Techniques, High-risk Patients Prone to Extubation Failure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 21 Sep 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.
In the intensive care unit (ICU), weaning from mechanical ventilation and extubation are critical clinical goals. Successful extubation not only significantly shortens mechanical ventilation duration but also reduces the incidence of complications such as ventilator-associated pneumonia. However, extubation failure rates remain high, especially in high-risk patient populations. Even after passing the Spontaneous Breathing Trial (SBT), 10%-25% of high-risk patients experience respiratory deterioration post-extubation, necessitating reintubation. Therefore, optimizing extubation strategies for high-risk patients is essential.
Currently, extubation techniques in clinical practice are primarily classified into negative pressure extubation and positive pressure extubation. Traditional negative pressure extubation involves continuous tracheal suction to clear secretions; however, this negative pressure can lead to alveolar collapse, regional ventilation mismatch, and an increased risk of aspiration. In contrast, positive pressure extubation maintains airway pressure (such as pressure support or positive end expiratory pressure), which theoretically facilitates the movement of subglottic secretions toward the oropharynx, while also promoting alveolar recruitment and improving ventilation/perfusion matching. Although randomized controlled trials have explored the safety of these two techniques, the conclusions remain controversial. Some studies suggest that positive pressure extubation reduces post-extubation hypoxemia and reintubation rates, while a meta-analysis indicates no statistically significant difference in overall complication rates between the two methods. This discrepancy may arise from heterogeneity in study populations, inadequate standardization of operational parameters, and the limited sensitivity of traditional monitoring methods in detecting regional pulmonary dynamic changes.
In recent years, Electrical Impedance Tomography (EIT) and Lung Ultrasound (LUS) have emerged as non-invasive bedside monitoring technologies, offering new insights into the physiological effects of extubation. EIT enables real-time dynamic imaging to quantitatively map both whole-lung and regional ventilation distributions, allowing for the sensitive detection of alveolar collapse or over-expansion. LUS, utilizing its B-line scoring system, provides an objective assessment of lung ventilation loss with high sensitivity and specificity. The combined use of these two techniques not only reveals the effects of extubation on overall oxygenation but also facilitates a detailed analysis of regional ventilation heterogeneity and compensatory mechanisms, thereby offering multimodal data to optimize extubation strategies.
This study proposes the design of a single-center, prospective, randomized controlled trial to systematically assess the physiological differences between positive pressure and negative pressure extubation techniques in high-risk patients prone to extubation failure. The goal is to provide evidence-based support for developing individualized extubation strategies tailored to high-risk patients.
Detailed description
Patients meeting at least one of the criteria for increased risk of extubation failure: be over 65 years of age or have any underlying chronic cardiac or pulmonary disease. Underlying chronic cardiac disease includes left ventricular dysfunction (left ventricular ejection fraction equal to or less than 45%); history of cardiogenic pulmonary edema; ischemic heart disease or persistent atrial fibrillation; underlying chronic lung disease including chronic obstructive pulmonary disease, obesity-hypopnea syndrome, or restrictive lung disease.
Patients meeting weaning criteria: resolution or improvement of the pathology that motivated intubation, clinical stability (heart rate (HR) < 140 bpm, systolic blood pressure (BP) 90-160 mmHg without vasopressors or at minimum doses); pass the spontaneous breathing trail (SBT): The ventilator was in pressure support mode, with a pressure support of 8 cmH20 and a positive end-expiratory pressure of 5 cmH20 for 30 min. SBT success criteria: respiratory rate/tidal volume ratio <105, respiratory rate >8 times/min or <35 times/min, spontaneous tidal volume >4 mL/kg, arterial oxygen saturation >0.90, arterial blood gas analysis pH value >7.35, Pa02/Fi02 >150 mmHg; adequate mentation (no sedation or adequate mentation on sedation, Glasgow Coma Scale (GCS) > 13) Electrical impedance tomography (EIT) is a noninvasive bedside imaging technique that allows real-time assessment of global and regional lung ventilation. It provides dynamic information on changes in tidal volume distribution and lung aeration, which may help to better understand the physiological effects of different extubation techniques.
This single-center randomized controlled study aims to compare the physiological effects of positive-pressure and negative-pressure extubation in adult patients at high risk of extubation failure. Patients will be randomly assigned to one of the two extubation techniques. Lung ventilation will be assessed using EIT before and after extubation. Extubation-related complications and changes in oxygenation parameters will also be recorded. The results of this study are expected to provide evidence to guide the selection of extubation techniques in high-risk patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive-pressure extubation | Experimental | Procedure: Positive-pressure extubationthe ventilator will be not disconnected. In the original SBT mode, the patient will be instructed to inhale forcefully. When the patient reached the peak inspiratory flow rate, the cuff will be deflated and the endotracheal tube will be removed without endotracheal suction. Once the endotracheal tube is removed, a suction tube is used to aspirate oropharyngeal secretions. |
| Negative-pressure extubation | Experimental | Procedure: Negative-pressure extubationdisconnect the ventilator, insert the suction tube into the endotracheal tube and pass it over the distal opening, perform continuous negative pressure suction in the trachea, and at the same time evacuate the cuff of the endotracheal tube, and remove the suction tube and the catheter together. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged ≥ 18 years undergoing MV for ≥ 24 h
- Patients meeting at least one of the criteria for increased risk of extubation failure
- Patients meeting weaning criteria
- Patients or their families agree to participate in this trial and sign an informed consent form
Key exclusion criteria (16 listed)
- General exclusion criteria:
- Specific exclusion criteria for ultrasound:
- Specific exclusion criteria for EIT:
- Withdrawal criteria:
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 |
|---|---|---|
| Positive-pressure extubationPositive pressure technique：the ventilator will be not disconnected. In the original SBT mode, the patient will be instructed to inhale forcefully. When the patient reached the peak inspiratory flow rate, the cuff will be deflated and the endotracheal tube will be removed without endotracheal suction. Once the endotracheal tube is removed, a suction tube is used to aspirate oropharyngeal secretions. | Procedure or surgery | Positive-pressure extubation |
| Negative-pressure extubationNegative pressure technique: disconnect the ventilator, insert the suction tube into the endotracheal tube and pass it over the distal opening, perform continuous negative pressure suction in the trachea, and at the same time evacuate the cuff of the endotracheal tube, and remove the suction tube and the catheter together. | Procedure or surgery | Negative-pressure extubation |
Primary outcome
The primary outcome is percentage of ROI3 and ROI4 measured by EIT monitoring
Time frame: Baseline (before spontaneous breathing test), immediately before extubation, 30 minutes after extubation, 2 hours after extubation, and 6 hours after extubation.
4 secondary outcomes
Regional Ventilation Delay (RVD) measured by Electrical Impedance Tomography (EIT)
Time frame: Baseline (before spontaneous breathing test), immediately before extubation, 30 minutes after extubation, 2 hours after extubation, and 6 hours after extubation.
Global Inhomogeneity Index (GI) measured by Electrical Impedance Tomography (EIT)
Time frame: Baseline (before spontaneous breathing test), immediately before extubation, 30 minutes after extubation, 2 hours after extubation, and 6 hours after extubation.
Center of Ventilation (COV) measured by Electrical Impedance Tomography (EIT)
Time frame: Baseline (before spontaneous breathing test), immediately before extubation, 30 minutes after extubation, 2 hours after extubation, and 6 hours after extubation.
End-Expiratory Lung Volume (EELV) measured by Electrical Impedance Tomography (EIT)
Time frame: Baseline (before spontaneous breathing test), immediately before extubation, 30 minutes after extubation, 2 hours after extubation, and 6 hours after extubation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Results publication: PubMed 25425709Andreu MF, Salvati IG, Donnianni MC, Ibanez B, Cotignola M, Bezzi M. Effect of applying positive pressure with or without endotracheal suctioning during extubation: a laboratory study. Respir Care. 2014 Dec;59(12):1905-11. doi: 10.4187/respcare.03121. Epub 2014 Nov 25.
- Results publication: PubMed 37752365Joussellin V, Bonny V, Spadaro S, Clerc S, Parfait M, Ferioli M, Sieye A, Jalil Y, Janiak V, Pinna A, Dres M. Lung aeration estimated by chest electrical impedance tomography and lung ultrasound during extubation. Ann Intensive Care. 2023 Sep 26;13(1):91. doi: 10.1186/s13613-023-01180-3.
- Results publication: PubMed 36828583Shimada K, Inokuchi R, Iwagami M, Tanaka M, Tamiya N. Comparison of Postextubation Complications Between Positive-Pressure and Suctioning Techniques: A Systematic Review. Respir Care. 2023 Mar;68(3):429-436. doi: 10.4187/respcare.10326.
- Results publication: PubMed 35574743Liu S, Ye Z, Zou H, Mei C, Hu Z, Xu W. [Comparison of positive and negative pressure extubation after mechanical ventilation in intensive care unit patients]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2022 Mar;34(3):265-268. doi: 10.3760/cma.j.cn121430-20211022-01545. Chinese.
- Results publication: PubMed 39283488Shimada K, Gosho M, Ohigashi T, Kume K, Yano T, Ishii R, Maruo K, Inokuchi R, Iwagami M, Ueda H, Tanaka M, Sanuki M, Tamiya N. Risk of postoperative pneumonia after extubation with the positive pressure versus normal pressure technique: a single-center retrospective observational study. J Anesth. 2025 Feb;39(1):5-14. doi: 10.1007/s00540-024-03409-2. Epub 2024 Sep 12.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the data contain potentially identifiable information, and data sharing is not covered by the current informed consent and ethics approval.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive-pressure extubation and Negative-pressure extubation in people with Positive Pressure Extubation Techniques and Negative Pressure Extubation Techniques, run by Shanghai Zhongshan Hospital at 1 site in China.
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 4 inclusion and 16 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: opening soon, as of the sponsor's last update on 21 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai Liu, Bachelor of Science (+86-21-31587871, liu.kai1@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is percentage of ROI3 and ROI4 measured by EIT monitoring (time frame: Baseline (before spontaneous breathing test), immediately before extubation, 30 minutes after extubation, 2 hours after extubation, and 6 hours 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 NCT07829627, which also lists 5 linked publications.
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 21 Sep 2026.