Intra-Abdominal HypertensionIAP-VENTNCT07889609
Intra-Abdominal Pressure, Respiratory Mechanics, and Ventilator Liberation After Emergency Major Laparotomy
An observational study of Intra-Abdominal Hypertension and Respiratory Mechanics, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational cohort study aims to investigate the relationship between intra-abdominal pressure (IAP), respiratory system mechanics, and successful liberation from invasive mechanical ventilation in adult patients admitted to the intensive care unit (ICU) following emergency major laparotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intra-Abdominal Hypertension, Respiratory Mechanics, Mechanical Ventilation
- What is being tested?
- Serial Intra-Abdominal Pressure and Respiratory Mechanics Assessment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2026to 28 Dec 2027
- Phase
- Observational
- 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
Study population: Adult patients aged 18 years or older who undergo non-traumatic emergency major laparotomy with primary abdominal fascial closure and require invasive mechanical ventilation upon postoperative admission to the general surgery intensive care unit of Bursa Yuksek Ihtisas Training and Research Hospital, Turkey, will constitute the study population. Eligible patients will be consecutively enrolled during the study period. All participants will undergo serial intra-abdominal pressure measurements and simultaneous assessment of respiratory system mechanics during the first 48 hours after ICU admission, followed by clinical outcome assessment through day 28.
Who may be able to join
- Age 18 years or older.
- Undergoing non-traumatic emergency major abdominal surgery performed through an open laparotomy.
- Direct admission to the intensive care unit following surgery.
- Receiving invasive mechanical ventilation through an endotracheal tube or tracheostomy at the time of postoperative ICU admission.
- Primary abdominal fascial closure performed at the end of surgery.
- Presence of an indwelling urinary catheter allowing intra-abdominal pressure measurement using the intravesical technique.
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- Availability of simultaneous intra-abdominal pressure and respiratory mechanics measurements at the initial assessment after ICU admission.
- Written informed consent obtained from the patient or, when the patient lacks decision-making capacity, from a legally authorized representative or an eligible relative in accordance with applicable regulations and ethics committee requirements.
- Additional written consent obtained from the patient for continued participation if decision-making capacity is regained during the study.
Who cannot join
- Age younger than 18 years.
- Elective abdominal surgery.
- Abdominal surgery completed laparoscopically without an open laparotomy.
- Laparotomy performed for traumatic injury.
- Open abdomen or temporary abdominal closure at the end of surgery.
- Planned second-look laparotomy or planned surgical reintervention within the first 48 hours.
Show all 17Show fewer
- Absence of invasive mechanical ventilation at postoperative ICU admission.
- Bladder injury, previous bladder surgery, neurogenic bladder, or other urinary tract conditions that may compromise the reliability of intravesical pressure measurements.
- Contraindication to urinary catheterization or inability to obtain reliable intra-abdominal pressure measurements through the urinary catheter.
- Bronchopleural fistula, significant endotracheal tube or ventilator circuit leakage, or other mechanical problems preventing reliable measurement of plateau pressure and static respiratory system compliance.
- Extracorporeal membrane oxygenation (ECMO) support.
- Pre-existing dependence on chronic invasive mechanical ventilation.
- Advanced neuromuscular disease, high-level spinal cord injury, or known diaphragmatic paralysis directly affecting ventilator liberation.
- Pregnancy.
- A decision for exclusively palliative care or limitation of life-sustaining treatment at ICU admission.
- Refusal to participate by the patient or legally authorized representative, or inability to obtain written informed consent.
- Inability to obtain simultaneous baseline intra-abdominal pressure and respiratory mechanics measurements at ICU admission.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, 16310
Ugur Duman, MD, +905458177971, ugur.duman@sbu.edu.tr
Mehmet C Gurkok, MD, +905324352880, mcgurkok@hotmail.com
About this study
Official title: Association of Intra-Abdominal Pressure With Respiratory System Mechanics and Ventilator Liberation Following Emergency Major Laparotomy: A Prospective Observational Cohort Study
This prospective observational cohort study aims to investigate the relationship between intra-abdominal pressure (IAP), respiratory system mechanics, and successful liberation from invasive mechanical ventilation in adult patients admitted to the intensive care unit (ICU) following emergency major laparotomy.
Increased intra-abdominal pressure may impair respiratory mechanics by reducing chest wall compliance, increasing airway pressures, and limiting diaphragmatic movement. These physiological changes may contribute to prolonged mechanical ventilation and difficulties in ventilator liberation.
Read more
The study will enroll 100 adult patients who undergo non-traumatic emergency major laparotomy with primary fascial closure and require invasive mechanical ventilation upon postoperative ICU admission.
Intra-abdominal pressure will be measured using a standardized intravesical technique through an existing urinary catheter. Serial measurements will be performed during the first 48 hours after ICU admission, alongside simultaneous assessments of respiratory system mechanics, including static respiratory system compliance and driving pressure.
The primary objectives are to evaluate the longitudinal association between IAP and static respiratory system compliance and to investigate whether early IAP trajectories are associated with time to successful liberation from invasive mechanical ventilation within 28 days.
Secondary outcomes include driving pressure, mechanical ventilation status on day 7, extubation failure, ventilator-free days through day 28, and mortality.
All clinical management decisions, including ventilator settings, sedation, spontaneous breathing trials, extubation, and tracheostomy, will remain under the responsibility of the treating ICU team. No study-directed therapeutic interventions will be performed.
Read the detailed description
Background and Rationale Increased intra-abdominal pressure (IAP) may adversely affect respiratory mechanics by displacing the diaphragm cranially, reducing chest wall compliance, and increasing airway pressures. These physiological changes are particularly relevant after emergency major laparotomy, when intra-abdominal sepsis, intestinal edema, fluid resuscitation, and abdominal fascial closure may contribute to elevated IAP.
Although previous studies have demonstrated associations between intra-abdominal hypertension and respiratory dysfunction in critically ill patients, prospective evidence examining simultaneous changes in IAP and respiratory system mechanics specifically after emergency major laparotomy remains limited. The relationship between early postoperative IAP trajectories and subsequent ventilator liberation also requires further investigation.
Study Design and Measurements This single-center, prospective observational cohort study will investigate longitudinal relationships between IAP, respiratory system mechanics, and ventilator liberation in mechanically ventilated adult patients following emergency major laparotomy.
Serial IAP measurements will be obtained using a standardized intravesical technique through an existing urinary catheter. Respiratory mechanics will be assessed at corresponding time points during the first 48 hours after intensive care unit admission.
Measurements will be performed under standardized conditions whenever clinically feasible. Static respiratory system compliance will be calculated from tidal volume, plateau pressure, and total positive end-expiratory pressure. Because esophageal pressure will not be measured, lung and chest wall compliance cannot be evaluated separately.
Clinical management, including mechanical ventilation, sedation, fluid administration, spontaneous breathing trials, and extubation decisions, will remain entirely under the responsibility of the treating intensive care team. No study-directed therapeutic interventions will be performed.
Analytical Approach Repeated measurements will allow the evaluation of both between-patient differences and within-patient changes in IAP and respiratory system mechanics. Linear mixed-effects models will account for the correlation between measurements obtained from the same patient.
Early postoperative IAP trajectories will also be characterized using measures of pressure magnitude, cumulative exposure, and temporal change. Their relationship with successful ventilator liberation will be evaluated using competing-risk analysis, with death considered a competing event.
The study aims to improve understanding of the physiological interaction between intra-abdominal pressure and respiratory system mechanics and to provide evidence supporting the identification of patients at risk of prolonged invasive mechanical ventilation after emergency major laparotomy.
- Being tested
- Serial Intra-Abdominal Pressure and Respiratory Mechanics Assessment
- Keywords
- Intra-Abdominal Pressure, Intra-Abdominal Hypertension, Emergency Laparotomy, Static Respiratory System Compliance, Driving Pressure, Ventilator Liberation, Weaning From Mechanical Ventilation, Postoperative Intensive Care, Intravesical Pressure Measurement, Ventilator-Free Days
- Medical subject headings
- Intra-Abdominal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial Intra-Abdominal Pressure and Respiratory Mechanics AssessmentOther
Intra-abdominal pressure will be measured using a standardized intravesical technique through an existing urinary catheter within the first hour after postoperative ICU admission and at 6, 12, 18, 24, 36, and 48 hours. Respiratory mechanics, including plateau pressure, positive end-expiratory pressure, tidal volume, static respiratory system compliance, and driving pressure, will be assessed simultaneously. An additional measurement at 72 hours may be obtained in patients who remain invasively mechanically ventilated. These assessments are observational and will not involve modifications to routine ventilator settings or clinical management.
| Study group | Role | What they receive |
|---|---|---|
| Emergency Major Laparotomy Cohort | Adult patients undergoing non-traumatic emergency major laparotomy with primary fascial closure who require invasive mechanical ventilation upon postoperative admission to the intensive care unit. All participants will undergo serial intra-abdominal pressure measurements using a standardized intravesical technique through an existing urinary catheter, together with simultaneous assessment of respiratory system mechanics during the first 48 hours after ICU admission. Patients will be followed for up to 28 days to evaluate successful liberation from invasive mechanical ventilation and other clinical outcomes. All treatment and ventilator management decisions will follow routine clinical practice without study-directed therapeutic interventions. Receives: Other: Serial Intra-Abdominal Pressure and Respiratory Mechanics Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association Between Intra-Abdominal Pressure and Static Respiratory System Compliance
The longitudinal association between intra-abdominal pressure (IAP, mmHg) and static respiratory system compliance (mL/cmH2O) will be evaluated using repeated simultaneous measurements obtained within the first hour after postoperative ICU admission and at 6, 12, 18, 24, 36, and 48 hours.
Static respiratory system compliance will be calculated as tidal volume divided by the difference between plateau pressure and total positive end-expiratory pressure (PEEP).
Linear mixed-effects models will be used to assess within-patient and between-patient associations between IAP and static respiratory system compliance, accounting for repeated measurements.
Measured: From ICU admission through 48 hours after ICU admission
Time to Successful Liberation From Invasive Mechanical Ventilation
Time from postoperative ICU admission to successful liberation from invasive mechanical ventilation will be assessed within 28 days.
Successful liberation is defined as extubation followed by survival without reintubation for seven consecutive days. The association between IAP trajectories during the first 48 hours and time to successful ventilator liberation will be evaluated using competing-risk regression, with death before successful liberation treated as a competing event.
Measured: From ICU admission through day 28
Secondary outcomes (9)
Association Between Intra-Abdominal Pressure and Driving Pressure
The longitudinal association between intra-abdominal pressure (mmHg) and respiratory system driving pressure (cmH2O) will be evaluated using simultaneous repeated measurements. Driving pressure will be calculated as plateau pressure minus total PEEP. Linear mixed-effects models will account for repeated measurements within individual patients.
Measured: From ICU admission through 48 hours after ICU admission
Invasive Mechanical Ventilation Requirement on Day 7
The proportion of participants who remain dependent on invasive mechanical ventilation on day 7 after postoperative ICU admission will be assessed. The association between early IAP measurements and continued ventilation will be investigated.
Measured: Day 7 after ICU admission
Early Extubation Failure
The proportion of extubated participants requiring reintubation within 48 hours after extubation will be recorded.
Measured: Within 48 hours after extubation, during the 28-day follow-up
Ventilator-Free Days Through Day 28
The number of days alive and free from invasive mechanical ventilation during the first 28 days after postoperative ICU admission will be calculated.
Measured: From ICU admission through day 28
Total Duration of Invasive Mechanical Ventilation
The cumulative duration of invasive mechanical ventilation will be recorded in hours from postoperative ICU admission, including subsequent invasive ventilation episodes during follow-up.
Measured: From ICU admission through day 28
Spontaneous Breathing Trial Failure
The proportion of participants experiencing failure of a spontaneous breathing trial (SBT) will be recorded. SBT failure will be determined according to predefined clinical criteria, including respiratory distress, oxygen desaturation, hemodynamic instability, or other signs of intolerance.
Measured: From ICU admission through day 28
Tracheostomy Requirement
The proportion of participants requiring tracheostomy during postoperative intensive care follow-up will be recorded.
Measured: From ICU admission through day 28
ICU Mortality Within 28 Days
The proportion of participants who die during their postoperative intensive care unit stay will be recorded.
Measured: From ICU admission through day 28
All-Cause Mortality at Day 28
The proportion of participants who die from any cause within 28 days after postoperative ICU admission will be recorded.
Measured: From ICU admission through day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion28 Dec 2027 (estimated)
- Study completion28 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ugur Duman, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Ugur Duman, MD, Principal investigator, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889609
- Sponsor's protocol ID
- YBU-IAP-SOL-2026
- Other IDs
- 2024-TBEK 2026/09-07
- Acronym
- IAP-VENT
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ziqiang S, Jiale L, Renhua S, Aiping W, Yin N, Jingquan L, Feng G, Lijun Y, Guoping G, Aijun D, Yunchao S, Changwen L, Lei X, Ronglin J, Jun L, Ronghai L, Yannan Z, Weidong W, Bo X, Bangchuan H. Ventilatory pressure parameters impact the association between acute gastrointestinal injury and all-cause mortality in mechanically ventilated patients. Sci Rep. 2024 Sep 5;14(1):20763. doi: 10.1038/s41598-024-71556-3.
PubMed 39237608Regli A, Pelosi P, Malbrain MLNG. Ventilation in patients with intra-abdominal hypertension: what every critical care physician needs to know. Ann Intensive Care. 2019 Apr 25;9(1):52. doi: 10.1186/s13613-019-0522-y.
PubMed 31025221Reintam Blaser A, Regli A, De Keulenaer B, Kimball EJ, Starkopf L, Davis WA, Greiffenstein P, Starkopf J; Incidence, Risk Factors, and Outcomes of Intra-Abdominal (IROI) Study Investigators. Incidence, Risk Factors, and Outcomes of Intra-Abdominal Hypertension in Critically Ill Patients-A Prospective Multicenter Study (IROI Study). Crit Care Med. 2019 Apr;47(4):535-542. doi: 10.1097/CCM.0000000000003623.
PubMed 30608280
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Intra-Abdominal Pressure With Respiratory System Mechanics and Ventilator Liberation Following Emergency Major Laparotomy: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07889609
- Acronym / sponsor ID
- IAP-VENT / YBU-IAP-SOL-2026
- Keywords
- Intra-Abdominal Pressure, Intra-Abdominal Hypertension, Emergency Laparotomy, Static Respiratory System Compliance, Driving Pressure, Ventilator Liberation, Weaning From Mechanical Ventilation, Postoperative Intensive Care
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 28 Dec 2027 (estimated)
- Study completion
- 28 Dec 2027 (estimated)
- First posted
- 22 Oct 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.
This prospective observational cohort study aims to investigate the relationship between intra-abdominal pressure (IAP), respiratory system mechanics, and successful liberation from invasive mechanical ventilation in adult patients admitted to the intensive care unit (ICU) following emergency major laparotomy.
Increased intra-abdominal pressure may impair respiratory mechanics by reducing chest wall compliance, increasing airway pressures, and limiting diaphragmatic movement. These physiological changes may contribute to prolonged mechanical ventilation and difficulties in ventilator liberation.
The study will enroll 100 adult patients who undergo non-traumatic emergency major laparotomy with primary fascial closure and require invasive mechanical ventilation upon postoperative ICU admission.
Intra-abdominal pressure will be measured using a standardized intravesical technique through an existing urinary catheter. Serial measurements will be performed during the first 48 hours after ICU admission, alongside simultaneous assessments of respiratory system mechanics, including static respiratory system compliance and driving pressure.
The primary objectives are to evaluate the longitudinal association between IAP and static respiratory system compliance and to investigate whether early IAP trajectories are associated with time to successful liberation from invasive mechanical ventilation within 28 days.
Secondary outcomes include driving pressure, mechanical ventilation status on day 7, extubation failure, ventilator-free days through day 28, and mortality.
All clinical management decisions, including ventilator settings, sedation, spontaneous breathing trials, extubation, and tracheostomy, will remain under the responsibility of the treating ICU team. No study-directed therapeutic interventions will be performed.
Detailed description
Background and Rationale Increased intra-abdominal pressure (IAP) may adversely affect respiratory mechanics by displacing the diaphragm cranially, reducing chest wall compliance, and increasing airway pressures. These physiological changes are particularly relevant after emergency major laparotomy, when intra-abdominal sepsis, intestinal edema, fluid resuscitation, and abdominal fascial closure may contribute to elevated IAP.
Although previous studies have demonstrated associations between intra-abdominal hypertension and respiratory dysfunction in critically ill patients, prospective evidence examining simultaneous changes in IAP and respiratory system mechanics specifically after emergency major laparotomy remains limited. The relationship between early postoperative IAP trajectories and subsequent ventilator liberation also requires further investigation.
Study Design and Measurements This single-center, prospective observational cohort study will investigate longitudinal relationships between IAP, respiratory system mechanics, and ventilator liberation in mechanically ventilated adult patients following emergency major laparotomy.
Serial IAP measurements will be obtained using a standardized intravesical technique through an existing urinary catheter. Respiratory mechanics will be assessed at corresponding time points during the first 48 hours after intensive care unit admission.
Measurements will be performed under standardized conditions whenever clinically feasible. Static respiratory system compliance will be calculated from tidal volume, plateau pressure, and total positive end-expiratory pressure. Because esophageal pressure will not be measured, lung and chest wall compliance cannot be evaluated separately.
Clinical management, including mechanical ventilation, sedation, fluid administration, spontaneous breathing trials, and extubation decisions, will remain entirely under the responsibility of the treating intensive care team. No study-directed therapeutic interventions will be performed.
Analytical Approach Repeated measurements will allow the evaluation of both between-patient differences and within-patient changes in IAP and respiratory system mechanics. Linear mixed-effects models will account for the correlation between measurements obtained from the same patient.
Early postoperative IAP trajectories will also be characterized using measures of pressure magnitude, cumulative exposure, and temporal change. Their relationship with successful ventilator liberation will be evaluated using competing-risk analysis, with death considered a competing event.
The study aims to improve understanding of the physiological interaction between intra-abdominal pressure and respiratory system mechanics and to provide evidence supporting the identification of patients at risk of prolonged invasive mechanical ventilation after emergency major laparotomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emergency Major Laparotomy Cohort | – | Other: Serial Intra-Abdominal Pressure and Respiratory Mechanics AssessmentAdult patients undergoing non-traumatic emergency major laparotomy with primary fascial closure who require invasive mechanical ventilation upon postoperative admission to the intensive care unit. All participants will undergo serial intra-abdominal pressure measurements using a standardized intravesical technique through an existing urinary catheter, together with simultaneous assessment of respiratory system mechanics during the first 48 hours after ICU admission. Patients will be followed for up to 28 days to evaluate successful liberation from invasive mechanical ventilation and other clinical outcomes. All treatment and ventilator management decisions will follow routine clinical practice without study-directed therapeutic interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18 years or older who undergo non-traumatic emergency major laparotomy with primary abdominal fascial closure and require invasive mechanical ventilation upon postoperative admission to the general surgery intensive care unit of Bursa Yuksek Ihtisas Training and Research Hospital, Turkey, will constitute the study population. Eligible patients will be consecutively enrolled during the study period. All participants will undergo serial intra-abdominal pressure measurements and simultaneous assessment of respiratory system mechanics during the first 48 hours after ICU admission, followed by clinical outcome assessment through day 28.
Key inclusion criteria (9 listed)
- Age 18 years or older.
- Undergoing non-traumatic emergency major abdominal surgery performed through an open laparotomy.
- Direct admission to the intensive care unit following surgery.
- Receiving invasive mechanical ventilation through an endotracheal tube or tracheostomy at the time of postoperative ICU admission.
- Primary abdominal fascial closure performed at the end of surgery.
Key exclusion criteria (17 listed)
- Age younger than 18 years.
- Elective abdominal surgery.
- Abdominal surgery completed laparoscopically without an open laparotomy.
- Laparotomy performed for traumatic injury.
- Open abdomen or temporary abdominal closure at the end of surgery.
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 |
|---|---|---|
| Serial Intra-Abdominal Pressure and Respiratory Mechanics AssessmentIntra-abdominal pressure will be measured using a standardized intravesical technique through an existing urinary catheter within the first hour after postoperative ICU admission and at 6, 12, 18, 24, 36, and 48 hours. Respiratory mechanics, including plateau pressure, positive end-expiratory pressure, tidal volume, static respiratory system compliance, and driving pressure, will be assessed simultaneously. An additional measurement at 72 hours may be obtained in patients who remain invasively mechanically ventilated. These assessments are observational and will not involve modifications to routine ventilator settings or clinical management. | Other | Emergency Major Laparotomy Cohort |
Primary outcome
Association Between Intra-Abdominal Pressure and Static Respiratory System Compliance
Time frame: From ICU admission through 48 hours after ICU admission
The longitudinal association between intra-abdominal pressure (IAP, mmHg) and static respiratory system compliance (mL/cmH2O) will be evaluated using repeated simultaneous measurements obtained within the first hour after postoperative ICU admission and at 6, 12, 18, 24, 36, and 48 hours. Static respiratory system compliance will be calculated as tidal volume divided by the difference between plateau pressure and total positive end-expiratory pressure (PEEP). Linear mixed-effects models will be used to assess within-patient and between-patient associations between IAP and static respiratory system compliance, accounting for repeated measurements.
Time to Successful Liberation From Invasive Mechanical Ventilation
Time frame: From ICU admission through day 28
Time from postoperative ICU admission to successful liberation from invasive mechanical ventilation will be assessed within 28 days. Successful liberation is defined as extubation followed by survival without reintubation for seven consecutive days. The association between IAP trajectories during the first 48 hours and time to successful ventilator liberation will be evaluated using competing-risk regression, with death before successful liberation treated as a competing event.
9 secondary outcomes
Association Between Intra-Abdominal Pressure and Driving Pressure
Time frame: From ICU admission through 48 hours after ICU admission
Invasive Mechanical Ventilation Requirement on Day 7
Time frame: Day 7 after ICU admission
Early Extubation Failure
Time frame: Within 48 hours after extubation, during the 28-day follow-up
Ventilator-Free Days Through Day 28
Time frame: From ICU admission through day 28
Total Duration of Invasive Mechanical Ventilation
Time frame: From ICU admission through day 28
Spontaneous Breathing Trial Failure
Time frame: From ICU admission through day 28
Tracheostomy Requirement
Time frame: From ICU admission through day 28
ICU Mortality Within 28 Days
Time frame: From ICU admission through day 28
All-Cause Mortality at Day 28
Time frame: From ICU admission through day 28
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 26 Oct 2026.
- Background: PubMed 39237608Ziqiang S, Jiale L, Renhua S, Aiping W, Yin N, Jingquan L, Feng G, Lijun Y, Guoping G, Aijun D, Yunchao S, Changwen L, Lei X, Ronglin J, Jun L, Ronghai L, Yannan Z, Weidong W, Bo X, Bangchuan H. Ventilatory pressure parameters impact the association between acute gastrointestinal injury and all-cause mortality in mechanically ventilated patients. Sci Rep. 2024 Sep 5;14(1):20763. doi: 10.1038/s41598-024-71556-3.
- Background: PubMed 31025221Regli A, Pelosi P, Malbrain MLNG. Ventilation in patients with intra-abdominal hypertension: what every critical care physician needs to know. Ann Intensive Care. 2019 Apr 25;9(1):52. doi: 10.1186/s13613-019-0522-y.
- Background: PubMed 30608280Reintam Blaser A, Regli A, De Keulenaer B, Kimball EJ, Starkopf L, Davis WA, Greiffenstein P, Starkopf J; Incidence, Risk Factors, and Outcomes of Intra-Abdominal (IROI) Study Investigators. Incidence, Risk Factors, and Outcomes of Intra-Abdominal Hypertension in Critically Ill Patients-A Prospective Multicenter Study (IROI Study). Crit Care Med. 2019 Apr;47(4):535-542. doi: 10.1097/CCM.0000000000003623.
- 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.
Ugur Duman, MD principal investigator
Bursa Yuksek Ihtisas Training and Research Hospital
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 Intra-Abdominal Hypertension and Respiratory Mechanics, run by Bursa Yuksek Ihtisas Training and Research Hospital 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 9 inclusion and 17 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 26 Oct 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?
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 Ugur Duman, MD (+905458177971, ugur.duman@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between Intra-Abdominal Pressure and Static Respiratory System Compliance (time frame: From ICU admission through 48 hours after ICU admission). The study lists 2 primary outcomes in all. 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 NCT07889609, which also lists 3 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 26 Oct 2026.