Chest Wall Influence on Respiratory System Mechanics in Morbidly Obese Patients

NCT02105220 | Completed

• 1 other identifier: 2013P001413
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Intra-Abdominal Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• End Expiratory Lung Volumes

  EELV variation at different levels of PEEP in mechanically ventilated and sedated morbidly obese patients and patients with intraabdominal hypertension

  2 hours

Secondary Outcomes (8)

• Respiratory mechanics

  24 hours

• Work of breathing

  20 minutes

• Respiratory mechanics

  2 hours

• Gas Exchange

  2 hours

• Respiratory mechanics

  20 minutes

Study Arms (2)

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.

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.

Other: Respiratory mechanics assessment

Interventions

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.

Intraabdominal Hypertension; Obese

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• years or older
• Requiring intubation and mechanical ventilation
• BMI≥40 kg/m2 or IAP≥12 mmHg

You may not qualify if:

• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Obesity; Intra-Abdominal Hypertension

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Robert M Kacmarek, PhD RRT

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD RRT

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: April 7, 2014
• Study Start: August 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 25, 2015

Record last verified: 2015-03

Locations

US (1)