Intra-abdominal HypertensionNCT06697717

End-expiratory Transpulmonary Pressure-guided vs Electrical Impedance Tomography-guided PEEP Titration Methods in Patients With Intra-abdominal Hypertension Combined With Acute Respiratory Distress Syndrome: a Randomized Crossover Controlled Study

A study testing Transpulmonary Pressure-Guided PEEP Titration in IAH and ARDS Patients and EIT-Guided PEEP Titration in IAH and ARDS Patients in people with Intra-abdominal Hypertension and Acute Respiratory Distress Syndrome (ARDS), run by XiaoJing Zou,MD at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Intra-abdominal Hypertension, Acute Respiratory Distress Syndrome (ARDS)
What is being tested?: Transpulmonary Pressure-Guided PEEP Titration in IAH and ARDS Patients and EIT-Guided PEEP Titration in IAH and ARDS Patients
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteChina
Study dates: 31 Dec 2024to 20 Feb 2026
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

age: 18-80 years;
meets IAH ≥12 mmHg;
meets the diagnostic criteria of the Berlin definition of ARDS;
PaO2/FiO2 ≤ 200;
within 36 hours of invasive mechanical ventilation;
patients or their family members were consulted, agreed to participate in the trial, and signed an informed consent form.

Who cannot join

Age <18 years or age >80 years;
uncorrected shock of any type;
chronic obstructive pulmonary disease, interstitial lung disease, pulmonary embolism, right heart failure, pulmonary hypertension, or severe cardiac arrhythmia;
pneumothorax or bronchopleural fistula or lobectomy or other surgery of the lungs within 2 weeks of surgery;
non-invasive ventilation or transnasal high-flow oxygen;
with relevant contraindications to the application of EIT (large chest skin injuries, infections, pacemaker implanters, in vivo automatic defibrillator implantation, etc.) pneumothorax, mediastinal emphysema, massive pleural effusion;

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oesophageal obstruction, oesophageal perforation, severe oesophageal variceal bleeding, upper gastrointestinal surgery, and other factors that make it impossible to place an oesophageal pressure catheter;
diaphragmatic hernia, thoracic deformity; patients with obvious pulmonary hernias;
prolongation of prothrombin time (PT), activated partial thromboplastin time (APTT) to two times the high limit of normal values or with active bleeding in the nasopharynx;
severe neurological disease: intracranial hypertension or neuromuscular disease, etc;
pregnant and lactating women;
patients to be treated with ECMO;
re-admission to the ICU of patients who have already been included in this study, or who are participating in other clinical studies;

Trial locations and contacts

1 site in 1 country.

China1 site

Wuhan Union Hospital
Wuhan, Hubei

Other trials in China

About this study

Official title: End-expiratory Transpulmonary Pressure-guided vs EIT-guided PEEP Titration Methods in Patients With Intra-abdominal Hypertension Combined With Acute Respiratory Distress Syndrome: a Randomized Crossover Controlled Study

This study aims to adopt a randomized crossover design to compare the effects of end-expiratory transpulmonary pressure-guided PEEP titration and EIT-guided PEEP titration on local lung ventilation, shunt, dead space, and ventilation-perfusion (V/Q) ratio as monitored by EIT. Additionally, it will evaluate their impact on respiratory mechanics, chest wall mechanics, mechanical power, hemodynamics, gas exchange, intra-abdominal pressure. By identifying an optimal PEEP titration strategy for patients with intra-abdominal hypertension (IAH) and acute respiratory distress syndrome (ARDS), this study aims to develop a mechanical ventilation approach that maintains lung recruitment and minimizes lung injury while avoiding adverse effects on other organs. The findings could facilitate the clinical application of this strategy and benefit a broader population of patients with IAH and ARDS.

Conditions: Intra-abdominal Hypertension, Acute Respiratory Distress Syndrome (ARDS)
Being tested: Transpulmonary Pressure-Guided PEEP Titration in IAH and ARDS Patients, EIT-Guided PEEP Titration in IAH and ARDS Patients
Medical subject headings: Intra-Abdominal Hypertension, Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transpulmonary Pressure-Guided PEEP Titration in IAH and ARDS PatientsOther
After completion of baseline ventilation and lung recruitment, the ventilator was switched to volume-controlled mode, and PEEP was set using an empirical PL-FiO₂ table, with the goal of maintaining end-expiratory transpulmonary pressure (PL) > 0 cmH₂O and end-inspiratory PL ≤ 20 cmH₂O.
EIT-Guided PEEP Titration in IAH and ARDS PatientsOther
After completion of baseline ventilation and lung recruitment, the ventilator was switched to pressure-controlled mode with a pressure control (PC) of 15 cmH₂O. PEEP was initially set at 24 cmH₂O and then gradually decreased in steps of 3 cmH₂O, with each PEEP level maintained for 2 minutes, down to a minimum of 3 cmH₂O, using the ODCL method for PEEP titration.

Study groups in NCT06697717
Study group	Role	What they receive
Transpulmonary Pressure-Guided PEEP Titration	Experimental	Not described Receives: Other: Transpulmonary Pressure-Guided PEEP Titration in IAH and ARDS Patients
EIT-Guided PEEP Titration	Experimental	Not described Receives: Other: EIT-Guided PEEP Titration in IAH and ARDS Patients

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference between the optimal PEEP titrated based on end-expiratory transpulmonary pressure and that guided by EIT
Measured: After PEEP titration

Secondary outcomes (2)

Electrical impedance tomography (EIT) parameters included: Global inhomogeneity (GI) index、Center of ventilation (CoV)、Shunt fraction、V/Q matching ,and so on
Measured: 30-minute ventilation after PEEP titration
Clinical respiratory and hemodynamic parameters
Measured: 30-minute ventilation after PEEP titration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Dec 202420 Feb 2026

First posted20 Nov 2024
Study start31 Dec 2024
Primary completion20 Feb 2026
Study completion20 Feb 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Intra-abdominal HypertensionStudies 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: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06697717
Sponsor's protocol ID: PEEP20240921
Status last verified: Jun 2026
First submitted: 18 Nov 2024
Last updated: 2 Sep 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
WSACS 2026 Delphi Consensus on the Practical Management of Intra-abdominal Hypertension and Abdominal Compartment Syndrome
Intra-Abdominal Hypertension, Abdominal Compartment Syndrome
Not yet recruitingObservational study
From Blast Injury to Multicompartment Dysfunction:
Compartment Syndrome, Compartment Syndrome Nontraumatic Lower Extremity
Not yet recruitingObservational study
Intra-Abdominal Pressure, Respiratory Mechanics, and Ventilator Liberation After Emergency Major Laparotomy
Intra-Abdominal Hypertension, Respiratory Mechanics
Not yet recruitingObservational study
Cumulative Intra-Abdominal Pressure Burden and Acute Kidney Injury After Emergency Abdominal Surgery
Acute Kidney Injury, Intra-Abdominal Hypertension
RecruitingObservational study
Intra-Abdominal Pressure Changes During Continuous Renal Replacement Therapy in Critically Ill Patients
Intra-Abdominal Hypertension, Critical Illness

All Intra-abdominal Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: End-expiratory Transpulmonary Pressure-guided vs EIT-guided PEEP Titration Methods in Patients With Intra-abdominal Hypertension Combined With Acute Respiratory Distress Syndrome: a Randomized Crossover Controlled Study
ClinicalTrials.gov ID: NCT06697717
Acronym / sponsor ID: PEEP20240921
Conditions: Intra-abdominal Hypertension, Acute Respiratory Distress Syndrome (ARDS)
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: XiaoJing Zou,MDUniversity, hospital or other
Study start: 31 Dec 2024 (actual)
Primary completion: 20 Feb 2026 (actual)
Study completion: 20 Feb 2026 (actual)
First posted: 20 Nov 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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Transpulmonary Pressure-Guided PEEP Titration	Experimental	Other: Transpulmonary Pressure-Guided PEEP Titration in IAH and ARDS Patients
EIT-Guided PEEP Titration	Experimental	Other: EIT-Guided PEEP Titration in IAH and ARDS Patients

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

age: 18-80 years;
meets IAH ≥12 mmHg;
meets the diagnostic criteria of the Berlin definition of ARDS;
PaO2/FiO2 ≤ 200;
within 36 hours of invasive mechanical ventilation;

Key exclusion criteria (13 listed)

Age <18 years or age >80 years;
uncorrected shock of any type;
chronic obstructive pulmonary disease, interstitial lung disease, pulmonary embolism, right heart failure, pulmonary hypertension, or severe cardiac arrhythmia;
pneumothorax or bronchopleural fistula or lobectomy or other surgery of the lungs within 2 weeks of surgery;
non-invasive ventilation or transnasal high-flow oxygen;

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
Transpulmonary Pressure-Guided PEEP Titration in IAH and ARDS PatientsAfter completion of baseline ventilation and lung recruitment, the ventilator was switched to volume-controlled mode, and PEEP was set using an empirical PL-FiO₂ table, with the goal of maintaining end-expiratory transpulmonary pressure (PL) > 0 cmH₂O and end-inspiratory PL ≤ 20 cmH₂O.	Other	Transpulmonary Pressure-Guided PEEP Titration
EIT-Guided PEEP Titration in IAH and ARDS PatientsAfter completion of baseline ventilation and lung recruitment, the ventilator was switched to pressure-controlled mode with a pressure control (PC) of 15 cmH₂O. PEEP was initially set at 24 cmH₂O and then gradually decreased in steps of 3 cmH₂O, with each PEEP level maintained for 2 minutes, down to a minimum of 3 cmH₂O, using the ODCL method for PEEP titration.	Other	EIT-Guided PEEP Titration

Primary outcome

Difference between the optimal PEEP titrated based on end-expiratory transpulmonary pressure and that guided by EIT
Time frame: After PEEP titration

2 secondary outcomes

Electrical impedance tomography (EIT) parameters included: Global inhomogeneity (GI) index、Center of ventilation (CoV)、Shunt fraction、V/Q matching ,and so on
Time frame: 30-minute ventilation after PEEP titration
Clinical respiratory and hemodynamic parameters
Time frame: 30-minute ventilation after PEEP titration

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 2 Sep 2026.
Individual participant dataSharing planned: No

Related trials for Intra-abdominal Hypertension

Enrolling by invitationObservational study
WSACS 2026 Delphi Consensus on the Practical Management of Intra-abdominal Hypertension and Abdominal Compartment Syndrome
Intra-Abdominal Hypertension, Abdominal Compartment Syndrome
Not yet recruitingObservational study
From Blast Injury to Multicompartment Dysfunction:
Compartment Syndrome, Compartment Syndrome Nontraumatic Lower Extremity
Not yet recruitingObservational study
Intra-Abdominal Pressure, Respiratory Mechanics, and Ventilator Liberation After Emergency Major Laparotomy
Intra-Abdominal Hypertension, Respiratory Mechanics
Not yet recruitingObservational study
Cumulative Intra-Abdominal Pressure Burden and Acute Kidney Injury After Emergency Abdominal Surgery
Acute Kidney Injury, Intra-Abdominal Hypertension
RecruitingObservational study
Intra-Abdominal Pressure Changes During Continuous Renal Replacement Therapy in Critically Ill Patients
Intra-Abdominal Hypertension, Critical Illness

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?

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 6 inclusion and 13 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 2 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?

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?

Difference between the optimal PEEP titrated based on end-expiratory transpulmonary pressure and that guided by EIT (time frame: After PEEP titration). 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 NCT06697717.

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 2 Sep 2026.