ObesityNCT02105220
Chest Wall Influence on Respiratory System Mechanics in Morbidly Obese Patients
An observational study of Obesity and Intra-Abdominal Hypertension, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The goal of this study is to describe the influence of the chest wall on the respiratory system mechanics in morbidly obese patients and in patients with high intra-abdominal pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Intra-Abdominal Hypertension
- What is being tested?
- Respiratory mechanics assessment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Mar 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will enroll morbidly obese intubated patients and/or patients affected by intraabdominal hypertension admitted to medical ICUs and surgical ICUs at Massachusetts General Hospital. Patients with contraindication to esophageal balloon placement or with severe respiratory failure will be excluded from the study.
Who may be able to join
- 18 years or older
- Requiring intubation and mechanical ventilation
- BMI≥40 kg/m2 or IAP≥12 mmHg
Who cannot join
- Known presence esophageal varices
- Recent esophageal trauma or surgery
- Severe thrombocytopenia (PTL≤10,000/mm3)
- Severe coagulopathy (INR≥2)
- Presence of pneumothorax
- Pregnancy
- Patients with diagnosed moderate to severe ARDS or with poor oxygenation index (PaO2/FiO2 < 200 mmHg)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The goal of this study is to describe the influence of the chest wall on the respiratory system mechanics in morbidly obese patients and in patients with high intra-abdominal pressure.
The effects of increasing and decreasing positive end-expiratory pressure (PEEP) on chest wall and total respiratory system mechanics, lung volumes and gas exchange will be evaluated, both during controlled and assisted mechanical ventilation.
Patients will be studied, first, during the acute phase of respiratory failure, when requiring intubation and controlled mechanical ventilation. Then, patients will be evaluated again during weaning from the ventilator to assess the influence of PEEP in assisted ventilation prior to extubation.
Read the detailed description
The goal of this study is to describe the influence of the chest wall on the respiratory system mechanics. Investigators want to describe how extreme obesity and Intra-Abdominal Hypertension (IAH) affect normal respiratory system behavior. The effects of increasing and decreasing positive end-expiratory pressure (PEEP) on respiratory system mechanics, lung volumes and gas exchange will be evaluated, both during controlled and assisted mechanical ventilation.
Investigators will record and compare lung volumes, airway and transpulmonary pressure, gas exchange and hemodynamic changes caused by variations of PEEP. Patients will be studied, first, during the acute phase of respiratory failure, when requiring intubation and controlled mechanical ventilation. Patients will then again be evaluated during weaning from the ventilator to assess the influence of PEEP in assisted ventilation prior to extubation.
Investigators believe that assessment of the transpulmonary pressure and lung volumes is essential to correctly evaluate respiratory system function in patients in which the relationship between the lung and chest wall is altered. Improper mechanical ventilation leads to lung damage. High ventilatory volume/pressure are associated with lung overdistension, while low volume/pressure leads to lung collapse and cyclic opening and closing of alveoli. All of these mechanisms have been associated with ventilator induced lung injury and poorer outcomes. Adequate PEEP and transpulmonary pressure are fundamental in preventing this vicious cycle.
- Conditions
- Obesity, Intra-Abdominal Hypertension
- Being tested
- Respiratory mechanics assessment
- Keywords
- Respiratory mechanics, Esophageal pressure, Functional residual capacity, positive end-expiratory pressure
- Medical subject headings
- Obesity, Intra-Abdominal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory mechanics assessmentOther
Data collection on respiratory mechanics, end expiratory lung volumes, gas exchanges, work of breathing. Data will be obtained by setting different end expiratory pressures and recording esophageal and airways pressure tracings.
| Study group | Role | What they receive |
|---|---|---|
| Obese | We will enroll patients with BMI≥40 kg/m2 to describe the impact of obesity on chest wall compliance and respiratory mechanics.
Respiratory mechanics assessment: We will assess respiratory mechanics through different end expiratory pressure settings and recording airway and esophageal pressure tracings. Receives: Other: Respiratory mechanics assessment | |
| Intraabdominal Hypertension | We will enroll patients with IAP≥12 mmHg to describe the impact of intraabdominal hypertension on chest wall compliance and respiratory mechanics.
Respiratory mechanics assessment: We will assess respiratory mechanics through different end expiratory pressure settings and recording airway and esophageal pressure tracings. Receives: Other: Respiratory mechanics assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
End Expiratory Lung Volumes
EELV variation at different levels of PEEP in mechanically ventilated and sedated morbidly obese patients and patients with intraabdominal hypertension
Measured: 2 hours
Secondary outcomes (8)
Respiratory mechanics
Evaluation of effects of PEEP level set by ICU staff on respiratory mechanics after 24 hours from enrollment Evaluation of PEEP level set by ICU staff
Measured: 24 hours
Work of breathing
Evaluation of work of breathing variation at different level of PEEP during spontaneous breathing and ventilation weaning in morbidly obese patients
Measured: 20 minutes
Respiratory mechanics
Respiratory mechanics variation at different levels of PEEP in mechanically ventilated and sedated morbidly obese patients and patients with intraabdominal hypertension
Measured: 2 hours
Gas Exchange
Gas exchange variation at different levels of PEEP in mechanically ventilated and sedated morbidly obese patients and patients with intraabdominal hypertension
Measured: 2 hours
Respiratory mechanics
Evaluation of respiratory mechanics at different level of PEEP during spontaneous breathing and ventilation weaning in morbidly obese patients
Measured: 20 minutes
Gas exchange
Evaluation of gas exchange variation at different level of PEEP during spontaneous breathing and ventilation weaning in morbidly obese patients
Measured: 20 minutes
End Expiratory Lung Volume
Evaluation of effects of PEEP level set by ICU staff on EELV after 24 hours from enrollment
Measured: 24 hours
Gas Exchange
Evaluation of effects of PEEP level set by ICU staff on gas exchange after 24 hours from enrollment
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startAug 2013
- Primary completionJan 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Massachusetts General 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert M. Kacmarek, Massachusetts General Hospital
- Investigators
- Robert M Kacmarek, PhD RRT, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105220
- Sponsor's protocol ID
- 2013P001413
- Status last verified
- Mar 2015
- First submitted
- 12 Feb 2014
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chest Wall Influence on Respiratory System Mechanics in Morbidly Obese Patients
- ClinicalTrials.gov ID
- NCT02105220
- Acronym / sponsor ID
- 2013P001413
- Conditions
- Obesity, Intra-Abdominal Hypertension
- Keywords
- Respiratory mechanics, Esophageal pressure, Functional residual capacity, positive end-expiratory pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 7 Apr 2014 (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.
The goal of this study is to describe the influence of the chest wall on the respiratory system mechanics in morbidly obese patients and in patients with high intra-abdominal pressure.
The effects of increasing and decreasing positive end-expiratory pressure (PEEP) on chest wall and total respiratory system mechanics, lung volumes and gas exchange will be evaluated, both during controlled and assisted mechanical ventilation.
Patients will be studied, first, during the acute phase of respiratory failure, when requiring intubation and controlled mechanical ventilation. Then, patients will be evaluated again during weaning from the ventilator to assess the influence of PEEP in assisted ventilation prior to extubation.
Detailed description
The goal of this study is to describe the influence of the chest wall on the respiratory system mechanics. Investigators want to describe how extreme obesity and Intra-Abdominal Hypertension (IAH) affect normal respiratory system behavior. The effects of increasing and decreasing positive end-expiratory pressure (PEEP) on respiratory system mechanics, lung volumes and gas exchange will be evaluated, both during controlled and assisted mechanical ventilation.
Investigators will record and compare lung volumes, airway and transpulmonary pressure, gas exchange and hemodynamic changes caused by variations of PEEP. Patients will be studied, first, during the acute phase of respiratory failure, when requiring intubation and controlled mechanical ventilation. Patients will then again be evaluated during weaning from the ventilator to assess the influence of PEEP in assisted ventilation prior to extubation.
Investigators believe that assessment of the transpulmonary pressure and lung volumes is essential to correctly evaluate respiratory system function in patients in which the relationship between the lung and chest wall is altered. Improper mechanical ventilation leads to lung damage. High ventilatory volume/pressure are associated with lung overdistension, while low volume/pressure leads to lung collapse and cyclic opening and closing of alveoli. All of these mechanisms have been associated with ventilator induced lung injury and poorer outcomes. Adequate PEEP and transpulmonary pressure are fundamental in preventing this vicious cycle.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese | – | Other: Respiratory mechanics assessmentWe will enroll patients with BMI≥40 kg/m2 to describe the impact of obesity on chest wall compliance and respiratory mechanics. Respiratory mechanics assessment: We will assess respiratory mechanics through different end expiratory pressure settings and recording airway and esophageal pressure tracings. |
| Intraabdominal Hypertension | – | Other: Respiratory mechanics assessmentWe will enroll patients with IAP≥12 mmHg to describe the impact of intraabdominal hypertension on chest wall compliance and respiratory mechanics. Respiratory mechanics assessment: We will assess respiratory mechanics through different end expiratory pressure settings and recording airway and esophageal pressure tracings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will enroll morbidly obese intubated patients and/or patients affected by intraabdominal hypertension admitted to medical ICUs and surgical ICUs at Massachusetts General Hospital. Patients with contraindication to esophageal balloon placement or with severe respiratory failure will be excluded from the study.
Key inclusion criteria (3 listed)
- 18 years or older
- Requiring intubation and mechanical ventilation
- BMI≥40 kg/m2 or IAP≥12 mmHg
Key exclusion criteria (7 listed)
- Known presence esophageal varices
- Recent esophageal trauma or surgery
- Severe thrombocytopenia (PTL≤10,000/mm3)
- Severe coagulopathy (INR≥2)
- Presence of pneumothorax
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 |
|---|---|---|
| Respiratory mechanics assessmentData collection on respiratory mechanics, end expiratory lung volumes, gas exchanges, work of breathing. Data will be obtained by setting different end expiratory pressures and recording esophageal and airways pressure tracings. | Other | Intraabdominal Hypertension, Obese |
Primary outcome
End Expiratory Lung Volumes
Time frame: 2 hours
EELV variation at different levels of PEEP in mechanically ventilated and sedated morbidly obese patients and patients with intraabdominal hypertension
8 secondary outcomes
Respiratory mechanics
Time frame: 24 hours
Work of breathing
Time frame: 20 minutes
Respiratory mechanics
Time frame: 2 hours
Gas Exchange
Time frame: 2 hours
Respiratory mechanics
Time frame: 20 minutes
Gas exchange
Time frame: 20 minutes
End Expiratory Lung Volume
Time frame: 24 hours
Gas Exchange
Time frame: 24 hours
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 25 Mar 2015.
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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.
Robert M Kacmarek, PhD RRT principal investigator
Massachusetts General 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 Obesity and Intra-Abdominal Hypertension, run by Massachusetts General Hospital at 1 site in United States.
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 7 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 25 Mar 2015. 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 United States. 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?
End Expiratory Lung Volumes (time frame: 2 hours). 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 25 Mar 2015.