Respiratory FailureIAP_SBTNCT01797614
Intra-abdominal Pressures During the Spontaneous Breathing Trial
An observational study of Respiratory Failure, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
Increased intra-abdominal pressure (IAP) affects pulmonary dynamics. However, little is studied whether pulmonary dynamics affects IAP. We hypothesize that the change of IAP can also reflect the change of pulmonary dynamics. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Respiratory Failure
- How many people
- 100 participants
- Where
- 2 sitesTaiwan
- Study dates
- Jan 2012to Dec 2013
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with endotracheal intubation and are preparing for weaning assessment
Who may be able to join
- Adult patients with endotracheal intubation in the intensive care unit
- The clinical condition is considered to prepare for weaning assessment
Who cannot join
- tracheostomy
- severe heart failure, heart disease or arrhythmia
- upper airway obstruction related respiratory failure
- poor cooperation due to agitation
- no foley catheter in place or had been removed
- baseline IAP above 20 mmHg
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Not yet recruiting
Nin-Chieh Hsu
Taipei, Taipei, 100
Nin-Chieh Hsu, M.D., chesthsu@gmail.com
Wen-Je Ko, M.D, PhD.
- Recruiting
National Taiwan University Hospital
Taipei, 100
About this study
Official title: Measuring the Change of Intra-abdominal Pressures of the Intensive Care Unit Patients During the Spontaneous Breathing Trial
Increased intra-abdominal pressure (IAP) affects pulmonary dynamics. However, little is studied whether pulmonary dynamics affects IAP. We hypothesize that the change of IAP can also reflect the change of pulmonary dynamics. In this study, we choose patients who received spontaneous breathing trial to answer the hypothesis.
Read the detailed description
During the weaning process, we tapered down the respiratory support from mechanical ventilation and recruited respiratory muscles to work. Previous study showed that transdiaphragmatic pressure was increasing while pressure support was reducing. However, the transdiaphragmatic pressure required invasive procedure to measure and not used frequently in weaning. IAP reflects the pleural pressure. If the PEEP is not changed, change of IAP is largely due to change of transpulmonary pressure.
Study Aim:
- To evaluate the patterns of change of IAP during SBT
- To predict success of SBT by the change of IAP
- To predict weaning outcome by the change of IAP
- Conditions
- Respiratory Failure
- Keywords
- intra-abdominal pressure, spontaneous breathing trail, weaning
- Medical subject headings
- Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the patterns of change of IAP during SBT
30min, 60min, 120min during a 2-hr SBT
Measured: 30min, 60min, 120min
Secondary outcomes (2)
To predict success of SBT by the change of IAP
To predict success of 2-hour IAP the change of IAP between 0 min and 30 min, and tha change of IAP beween 0 min and 120 min
Measured: 0 min, 30 min, 120 min
To predict weaning success by the change of IAP
To predict weaning success by the change of IAP between 0 min and 30 min, and tha change of IAP beween 0 min and 120 min
Measured: 0 min, 30 min, 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startJan 2012
- Primary completionJul 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nin-Chieh Hsu, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797614
- Sponsor's protocol ID
- 201108062RC
- Acronym
- IAP_SBT
- Status last verified
- Feb 2013
- First submitted
- 20 Feb 2013
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Change of Intra-abdominal Pressures of the Intensive Care Unit Patients During the Spontaneous Breathing Trial
- ClinicalTrials.gov ID
- NCT01797614
- Acronym / sponsor ID
- IAP_SBT / 201108062RC
- Conditions
- Respiratory Failure
- Keywords
- intra-abdominal pressure, spontaneous breathing trail, weaning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 22 Feb 2013 (estimated)
- 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.
Increased intra-abdominal pressure (IAP) affects pulmonary dynamics. However, little is studied whether pulmonary dynamics affects IAP. We hypothesize that the change of IAP can also reflect the change of pulmonary dynamics. In this study, we choose patients who received spontaneous breathing trial to answer the hypothesis.
Detailed description
During the weaning process, we tapered down the respiratory support from mechanical ventilation and recruited respiratory muscles to work. Previous study showed that transdiaphragmatic pressure was increasing while pressure support was reducing. However, the transdiaphragmatic pressure required invasive procedure to measure and not used frequently in weaning. IAP reflects the pleural pressure. If the PEEP is not changed, change of IAP is largely due to change of transpulmonary pressure.
Study Aim:
- To evaluate the patterns of change of IAP during SBT
- To predict success of SBT by the change of IAP
- To predict weaning outcome by the change of IAP
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with endotracheal intubation and are preparing for weaning assessment
Key inclusion criteria (2 listed)
- Adult patients with endotracheal intubation in the intensive care unit
- The clinical condition is considered to prepare for weaning assessment
Key exclusion criteria (6 listed)
- tracheostomy
- severe heart failure, heart disease or arrhythmia
- upper airway obstruction related respiratory failure
- poor cooperation due to agitation
- no foley catheter in place or had been removed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the patterns of change of IAP during SBT
Time frame: 30min, 60min, 120min
30min, 60min, 120min during a 2-hr SBT
2 secondary outcomes
To predict success of SBT by the change of IAP
Time frame: 0 min, 30 min, 120 min
To predict weaning success by the change of IAP
Time frame: 0 min, 30 min, 120 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2013.
Related trials for Respiratory Failure
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Regional Lung Ventilation During Prone Position in in Intubated Children
Pediatric Acute Respiratory Failure
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
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.
Nin-Chieh Hsu, MD principal investigator
National Taiwan University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure, run by National Taiwan University Hospital at 2 sites in Taiwan.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nin-Chieh Hsu, MD (886-2-23123456 ext. 62557, chesthsu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the patterns of change of IAP during SBT (time frame: 30min, 60min, 120min). 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 22 Feb 2013.