Intraabdominal HypertensionBPvsNIRSNCT05971264
Comparison of Bladder Pressure Versus Regional Intestinal Tissue Oxygenation in Infants
A study testing Near infrared-spectroscopy in people with Intraabdominal Hypertension and Abdominal Compartment Syndrome, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial summary
The goal of this clinical trial is to learn more about intestinal regional oxygen saturation measurements made with near-infrared spectroscopy and bladder pressure measurements in infants without risk of intraabdominal hypertension. Read more about this study
- Who is it for?
- Ages Up to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Intraabdominal Hypertension, Abdominal Compartment Syndrome
- What is being tested?
- Near infrared-spectroscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 May 2024to 25 Jul 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 Up to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Prepped and consented for laparoscopic pyeloplasty or minimal PSARP with perineal or vestibular fistula or lateral thoracotomy for the correction of esophageal atresia
- Age of 12 months old or less at operation
- Legal custodian gives consent
Who cannot join
- Anterior abdominal wall thickness greater than 12 mm measured on preoperative MRI imaging if available
- Patients planned for additional intestinal surgeries or non-standard pyeloplasty, e.g. pyeloplasty with nephrostoma
- Patients planned for laparoscopic pyeloplasty whose intraoperative urine sample shows pathological results
- Patients with esophageal atresia who experience pulmonary decompensation and need urgent surgery for fistula clipping
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Children's Hospital Zurich
Zurich, Canton of Zurich, 8032
About this study
The goal of this clinical trial is to learn more about intestinal regional oxygen saturation measurements made with near-infrared spectroscopy and bladder pressure measurements in infants without risk of intraabdominal hypertension. The main question it aims to answer is if - in comparison to bladder pressure - the regional intestinal oxygen saturation measured with near-infrared spectroscopy is stable in the muscle-relaxed, intubated patients and the awake and non-sedated patient.
In case of participation the bladder pressure and the regional intestinal oxygen saturation (measured with near-infrared spectroscopy) will each be measured once intraoperatively and once postoperatively. Patients included in this study will be undergoing an operation which necessitates muscle-relaxation, as well as an indwelling urinary catheter during the operation and for a short-time thereafter for other reasons than this study.
- Being tested
- Near infrared-spectroscopy
- Keywords
- Near infra-red spectroscopy, Bladder pressure, Intraabdominal pressure
- 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.
Near infrared-spectroscopyDiagnostic test
Comparison of regional intestinal oxygen saturation (measured with near infrared-spectroscopy) and indirect intraabdominal pressure measurement (bladder pressure) in muscle-relaxed, sedated patients compared to awake, non-sedated patients.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Diagnostic Test: Near infrared-spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal rSpO2 measurements in muscle-relaxed, intubated patients
Our primary endpoint is the regional intestinal oxygen saturation (rSpO2) measurement (average of 5 measurements taken every 30 seconds within 2 minutes) in muscle-relaxed, intubated patients
Measured: intraoperative measurements taken within the first 10 minutes after anaesthesia induction
Intestinal rSpO2 measurements in awake, non-sedated patients
Our primary endpoint is the regional intestinal oxygen saturation (rSpO2) measurements (average of 5 measurements taken every 30 seconds within 2 minutes) in awake, non-sedated patients
Measured: postoperative measurements taken within the first three postoperative days
Secondary outcomes (1)
Bladder pressure values
Bladder pressure measurements measured under two different circumstances: once muscle-relaxed, intubated patients (i.e. under ideal circumstances for these measurements) and once in awake, non-sedated patients (less ideal circumstances).
Measured: taken once intraoperatively within the first 10 minutes after anaesthesia induction and once postoperatively within the first three postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start17 May 2024
- Primary completion23 Jul 2026
- Study completion25 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraabdominal 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hannah R Neeser, MD, Principal investigator, University Children's Hospital of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971264
- Sponsor's protocol ID
- 1002
- Acronym
- BPvsNIRS
- Status last verified
- Jul 2026
- First submitted
- 15 May 2023
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bladder Pressure Versus Regional Intestinal Tissue Oxygenation in Infants
- ClinicalTrials.gov ID
- NCT05971264
- Acronym / sponsor ID
- BPvsNIRS / 1002
- Keywords
- Near infra-red spectroscopy, Bladder pressure, Intraabdominal pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- 17 May 2024 (actual)
- Primary completion
- 23 Jul 2026 (actual)
- Study completion
- 25 Jul 2026 (actual)
- First posted
- 2 Aug 2023 (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.
The goal of this clinical trial is to learn more about intestinal regional oxygen saturation measurements made with near-infrared spectroscopy and bladder pressure measurements in infants without risk of intraabdominal hypertension. The main question it aims to answer is if - in comparison to bladder pressure - the regional intestinal oxygen saturation measured with near-infrared spectroscopy is stable in the muscle-relaxed, intubated patients and the awake and non-sedated patient.
In case of participation the bladder pressure and the regional intestinal oxygen saturation (measured with near-infrared spectroscopy) will each be measured once intraoperatively and once postoperatively. Patients included in this study will be undergoing an operation which necessitates muscle-relaxation, as well as an indwelling urinary catheter during the operation and for a short-time thereafter for other reasons than this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Diagnostic Test: Near infrared-spectroscopy |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Prepped and consented for laparoscopic pyeloplasty or minimal PSARP with perineal or vestibular fistula or lateral thoracotomy for the correction of esophageal atresia
- Age of 12 months old or less at operation
- Legal custodian gives consent
Key exclusion criteria (4 listed)
- Anterior abdominal wall thickness greater than 12 mm measured on preoperative MRI imaging if available
- Patients planned for additional intestinal surgeries or non-standard pyeloplasty, e.g. pyeloplasty with nephrostoma
- Patients planned for laparoscopic pyeloplasty whose intraoperative urine sample shows pathological results
- Patients with esophageal atresia who experience pulmonary decompensation and need urgent surgery for fistula clipping
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 |
|---|---|---|
| Near infrared-spectroscopyComparison of regional intestinal oxygen saturation (measured with near infrared-spectroscopy) and indirect intraabdominal pressure measurement (bladder pressure) in muscle-relaxed, sedated patients compared to awake, non-sedated patients. | Diagnostic test | Single Arm |
Primary outcome
Intestinal rSpO2 measurements in muscle-relaxed, intubated patients
Time frame: intraoperative measurements taken within the first 10 minutes after anaesthesia induction
Our primary endpoint is the regional intestinal oxygen saturation (rSpO2) measurement (average of 5 measurements taken every 30 seconds within 2 minutes) in muscle-relaxed, intubated patients
Intestinal rSpO2 measurements in awake, non-sedated patients
Time frame: postoperative measurements taken within the first three postoperative days
Our primary endpoint is the regional intestinal oxygen saturation (rSpO2) measurements (average of 5 measurements taken every 30 seconds within 2 minutes) in awake, non-sedated patients
1 secondary outcome
Bladder pressure values
Time frame: taken once intraoperatively within the first 10 minutes after anaesthesia induction and once postoperatively within the first three postoperative days
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 29 Jul 2026.
- 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.
Hannah R Neeser, MD principal investigator
University Children's Hospital of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Near infrared-spectroscopy in people with Intraabdominal Hypertension and Abdominal Compartment Syndrome, run by University Children's Hospital, Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 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 29 Jul 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 Switzerland. 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?
Intestinal rSpO2 measurements in muscle-relaxed, intubated patients (time frame: intraoperative measurements taken within the first 10 minutes after anaesthesia induction). 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?
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 29 Jul 2026.