- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02105220
Chest Wall Influence on Respiratory System Mechanics in Morbidly Obese Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18 years or older
- Requiring intubation and mechanical ventilation
- BMI≥40 kg/m2 or IAP≥12 mmHg
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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. |
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.
|
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Respiratory mechanics
Time Frame: 24 hours
|
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
|
24 hours
|
Work of breathing
Time Frame: 20 minutes
|
Evaluation of work of breathing variation at different level of PEEP during spontaneous breathing and ventilation weaning in morbidly obese patients
|
20 minutes
|
Respiratory mechanics
Time Frame: 2 hours
|
Respiratory mechanics variation at different levels of PEEP in mechanically ventilated and sedated morbidly obese patients and patients with intraabdominal hypertension
|
2 hours
|
Gas Exchange
Time Frame: 2 hours
|
Gas exchange variation at different levels of PEEP in mechanically ventilated and sedated morbidly obese patients and patients with intraabdominal hypertension
|
2 hours
|
Respiratory mechanics
Time Frame: 20 minutes
|
Evaluation of respiratory mechanics at different level of PEEP during spontaneous breathing and ventilation weaning in morbidly obese patients
|
20 minutes
|
Gas exchange
Time Frame: 20 minutes
|
Evaluation of gas exchange variation at different level of PEEP during spontaneous breathing and ventilation weaning in morbidly obese patients
|
20 minutes
|
End Expiratory Lung Volume
Time Frame: 24 hours
|
Evaluation of effects of PEEP level set by ICU staff on EELV after 24 hours from enrollment
|
24 hours
|
Gas Exchange
Time Frame: 24 hours
|
Evaluation of effects of PEEP level set by ICU staff on gas exchange after 24 hours from enrollment
|
24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert M Kacmarek, PhD RRT, Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013P001413
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Fundació Sant Joan de DéuNot yet recruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Respiratory mechanics assessment
-
University of Modena and Reggio EmiliaCompletedCOPD Exacerbation | Mechanical Ventilation | Diaphragm DysfunctionItaly
-
Unity Health TorontoCanadian Institutes of Health Research (CIHR); University of Toronto; Applied...RecruitingARDSFrance, Canada, Chile, Italy, Argentina, Spain, United States
-
I.M. Sechenov First Moscow State Medical UniversityCompletedSARS PneumoniaRussian Federation
-
Fondazione IRCCS Ca' Granda, Ospedale Maggiore...Politecnico di MilanoNot yet recruitingRespiratory Distress Syndrome in Premature Infant
-
Southeast University, ChinaUnknownEndothelial Dysfunction | ARDS, Human | Mechanical Ventilation Pressure HighChina
-
University of ZurichRecruitingCovid19 | ARDSSwitzerland
-
Future University in EgyptCompletedBimaxillary ProtrusionEgypt
-
University of MichiganU.S. Department of EducationCompletedUrinary Bladder, Neurogenic | Neurogenic Bowel | Injuries, Spinal CordUnited States
-
Universidade Federal de PernambucoCompleted
-
University Hospital, AntwerpCompleted