Driving PressureNCT06471491
Driving Pressure-guided Positive End-expiratory Pressure to Prevent Postoperative Atelectasis in Obese Children: a Prospective, Randomized Controlled Clinical Trial
A study testing Driving pressure-guided positive end-expiratory pressure in people with Driving Pressure and Positive End-expiratory Pressure, run by Henan Provincial People's Hospital at 1 site in China.
Trial summary
At present, the use of lung protective ventilation strategies in children is mainly based on adult and intensive care unit data. Although obese children may benefit more from lung protective ventilation, there are few studies on the use of lung protective ventilation strategies in obese children during surgery. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Driving Pressure, Positive End-expiratory Pressure, Postoperative Atelectasis
- What is being tested?
- Driving pressure-guided positive end-expiratory pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 11 Sep 2024to 15 Mar 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 3-18 years old;
- According to the People's Republic of China health industry standard "Overweight and Obesity Screening threshold for school-age children and adolescents WS_T586-2018" defined as obesity;
- American Society of Anesthesiologists (ASA) grades I - II;
- Children with healthy lungs and hearts;
- Patients with general anesthesia under tracheal intubation;
- Clear mind and able to cooperate with the anesthesiologist to receive treatment;
- Patients who plan to have elective surgery under general anesthesia and the estimated operation duration is ≥2 hours.
Who cannot join
- PEEP contraindications: (a) bronchopleural fistula; (b) hypovolemic shock; (c) right ventricular failure;
- American Society of Anesthesiologists (ASA) grade greater than II;
- Pulmonary dysfunction, congenital heart disease children;
- Refusal to participate in the study and/or use personal data, preoperative intubation or ventilation of children;
- Children with upper respiratory tract infection within 2 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
At present, the use of lung protective ventilation strategies in children is mainly based on adult and intensive care unit data. Although obese children may benefit more from lung protective ventilation, there are few studies on the use of lung protective ventilation strategies in obese children during surgery. Therefore, the investigators hypothesized that intraoperative use of LPV strategies in obese pediatric surgery patients can reduce atelectasis and improve the incidence of postoperative pulmonary complications.
Read the detailed description
In the lung protective ventilation group, PEEP was titrated individually in a sequential manner after mechanical ventilation. According to previous studies, PEEP was 5 cmH2O, inspiratory pressure was 20 cmH2O, and respiratory rate was set according to patient age. PEEP and inspiratory pressure were increased by 5 cmH2O every 30 seconds until PEEP was 15 cmH2O and inspiratory pressure 30 cmH2O. This was followed by a decreasing amplitude of 2 cmH2O to 3 cmH2O starting from 15 cmH2O, and each PEEP level was maintained for 4 to 5 respiratory cycles.The PEEP was at the lowest driving pressure was applied throughout the procedure. The PEEP level resulting in the lowest driving pressure was applied during surgery. In the traditional mechanical ventilation group, a fixed PEEP of 5 cm H2O was applied. The investigators compared the incidence of postoperative atelectasis between the two groups using lung ultrasound.
- Being tested
- Driving pressure-guided positive end-expiratory pressure
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Driving pressure-guided positive end-expiratory pressureOther
Driving pressure-guided positive end-expiratory pressure during the surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| Lung protective ventilation group | Experimental | PEEP was titrated individually in a sequential manner after mechanical ventilation. According to previous studies, PEEP was 5 cmH2O, inspiratory pressure was 20 cmH2O, and respiratory rate was set according to patient age. PEEP and inspiratory pressure were increased by 5 cmH2O every 30 seconds until PEEP was 15 cmH2O and inspiratory pressure 30 cmH2O. This was followed by a decreasing amplitude of 2 cmH2O to 3 cmH2O starting from 15 cmH2O, and each PEEP level was maintained for 4 to 5 respiratory cycles.The PEEP was at the lowest driving pressure was applied throughout the procedure. The PEEP level resulting in the lowest driving pressure was applied during surgery. Receives: Other: Driving pressure-guided positive end-expiratory pressure |
| Traditional mechanical ventilation group | No intervention | In the traditional mechanical ventilation group, a fixed PEEP of 5 cm H2O was applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of atelectasis in both groups at the end of surgery
Incidence of atelectasis in both groups at the end of surgery
Measured: at the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start11 Sep 2024
- Primary completion31 Dec 2024
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Driving PressureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Zhou, Study chair, Henan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471491
- Sponsor's protocol ID
- PEEP
- Status last verified
- Jul 2025
- First submitted
- 31 May 2024
- Last updated
- 23 Jul 2025
- Results posted
- 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 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Driving Pressure-guided Positive End-expiratory Pressure to Prevent Postoperative Atelectasis in Obese Children: a Prospective, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06471491
- Acronym / sponsor ID
- PEEP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 24 Jun 2024 (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.
At present, the use of lung protective ventilation strategies in children is mainly based on adult and intensive care unit data. Although obese children may benefit more from lung protective ventilation, there are few studies on the use of lung protective ventilation strategies in obese children during surgery. Therefore, the investigators hypothesized that intraoperative use of LPV strategies in obese pediatric surgery patients can reduce atelectasis and improve the incidence of postoperative pulmonary complications.
Detailed description
In the lung protective ventilation group, PEEP was titrated individually in a sequential manner after mechanical ventilation. According to previous studies, PEEP was 5 cmH2O, inspiratory pressure was 20 cmH2O, and respiratory rate was set according to patient age. PEEP and inspiratory pressure were increased by 5 cmH2O every 30 seconds until PEEP was 15 cmH2O and inspiratory pressure 30 cmH2O. This was followed by a decreasing amplitude of 2 cmH2O to 3 cmH2O starting from 15 cmH2O, and each PEEP level was maintained for 4 to 5 respiratory cycles.The PEEP was at the lowest driving pressure was applied throughout the procedure. The PEEP level resulting in the lowest driving pressure was applied during surgery. In the traditional mechanical ventilation group, a fixed PEEP of 5 cm H2O was applied. The investigators compared the incidence of postoperative atelectasis between the two groups using lung ultrasound.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung protective ventilation group | Experimental | Other: Driving pressure-guided positive end-expiratory pressurePEEP was titrated individually in a sequential manner after mechanical ventilation. According to previous studies, PEEP was 5 cmH2O, inspiratory pressure was 20 cmH2O, and respiratory rate was set according to patient age. PEEP and inspiratory pressure were increased by 5 cmH2O every 30 seconds until PEEP was 15 cmH2O and inspiratory pressure 30 cmH2O. This was followed by a decreasing amplitude of 2 cmH2O to 3 cmH2O starting from 15 cmH2O, and each PEEP level was maintained for 4 to 5 respiratory cycles.The PEEP was at the lowest driving pressure was applied throughout the procedure. The PEEP level resulting in the lowest driving pressure was applied during surgery. |
| Traditional mechanical ventilation group | No intervention | –In the traditional mechanical ventilation group, a fixed PEEP of 5 cm H2O was applied. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age 3-18 years old;
- According to the People's Republic of China health industry standard "Overweight and Obesity Screening threshold for school-age children and adolescents WS_T586-2018" defined as obesity;
- American Society of Anesthesiologists (ASA) grades I - II;
- Children with healthy lungs and hearts;
- Patients with general anesthesia under tracheal intubation;
Key exclusion criteria (5 listed)
- PEEP contraindications: (a) bronchopleural fistula; (b) hypovolemic shock; (c) right ventricular failure;
- American Society of Anesthesiologists (ASA) grade greater than II;
- Pulmonary dysfunction, congenital heart disease children;
- Refusal to participate in the study and/or use personal data, preoperative intubation or ventilation of children;
- Children with upper respiratory tract infection within 2 weeks.
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 |
|---|---|---|
| Driving pressure-guided positive end-expiratory pressureDriving pressure-guided positive end-expiratory pressure during the surgical procedure | Other | Lung protective ventilation group |
Primary outcome
Incidence of atelectasis in both groups at the end of surgery
Time frame: at the end of surgery
Incidence of atelectasis in both groups at the end of surgery
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 Jul 2025.
- 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.
Jun Zhou study chair
Henan Provincial People's 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 Driving pressure-guided positive end-expiratory pressure in people with Driving Pressure and Positive End-expiratory Pressure, run by Henan Provincial People's 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 7 inclusion and 5 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 Jul 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 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?
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 atelectasis in both groups at the end of surgery (time frame: at the end of surgery). 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 Jul 2025.