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Completed

NCT Number: 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Respiratory mechanics assessment

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Gas Exchange

    Time frame: 24 hours

    Evaluation of effects of PEEP level set by ICU staff on gas exchange after 24 hours from enrollment

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 7, 2014
Registry last updated
Mar 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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