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Chest Wall Influence on Respiratory System Mechanics in Morbidly Obese Patients

Chest Wall Influence on Respiratory System Mechanics in Morbidly Obese Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02105220
Enrollment
14
Registered
2014-04-07
Start date
2013-08-31
Completion date
2015-03-31
Last updated
2015-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intra-Abdominal Hypertension, Obesity

Keywords

Respiratory mechanics, Esophageal pressure, Functional residual capacity, positive end-expiratory pressure

Brief 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. 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.

Interventions

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.

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
End Expiratory Lung Volumes2 hoursEELV variation at different levels of PEEP in mechanically ventilated and sedated morbidly obese patients and patients with intraabdominal hypertension

Secondary

MeasureTime frameDescription
Respiratory mechanics24 hoursEvaluation 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
Work of breathing20 minutesEvaluation of work of breathing variation at different level of PEEP during spontaneous breathing and ventilation weaning in morbidly obese patients
Gas Exchange2 hoursGas exchange variation at different levels of PEEP in mechanically ventilated and sedated morbidly obese patients and patients with intraabdominal hypertension
Gas exchange20 minutesEvaluation of gas exchange variation at different level of PEEP during spontaneous breathing and ventilation weaning in morbidly obese patients
End Expiratory Lung Volume24 hoursEvaluation of effects of PEEP level set by ICU staff on EELV after 24 hours from enrollment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026