Open Lung Strategy in Critically Ill Morbid Obese Patients

NCT02503241 | Unknown

• 1 other identifier: PRICESEOBESE
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional crossover study in morbidly obese intubated and mechanically ventilated patients is to describe the respiratory mechanics and the heart-lung interaction at titrated positive end-expiratory pressure levels following a recruitment maneuver with transthoracic echocardiography and electric impedance tomography imaging.

Conditions

Obesity; Respiratory Insufficiency; Right-Sided Heart Failure; Pulmonary Atelectasis; Respiratory Mechanics

Outcome Measures

Primary Outcomes (1)

• Respiratory System Elastance

  Difference in Respiratory System Elastance measured in cmH2O/L

  During study time points :baseline, PEEP incremental, PEEP decremental

Secondary Outcomes (3)

• Lung mechanics - Compliance

  Study time points: baseline, PEEP incremental, PEEP decremental

• Lung mechanics - Airway resistances

  During study time points: baseline, PEEP incremental, PEEP decremental

• Survival

  28 days after the performance of the study protocol

Other Outcomes (21)

• Intra-abdominal pressure

  Study time point: baseline

• Electrical Impedance Tomography measurement: collapsed and overdistension

  Study time points: baseline, PEEP incremental, PEEP decremental

• Electrical Impedance Tomography measurement: distribution of ventilation

  Study time points: baseline, PEEP incremental, PEEP decremental

Study Arms (2)

PEEP_Titration_INCREMENTAL

EXPERIMENTAL

The investigators will compare 3 levels of PEEP (BASELINE versus PEEP INCREMENTAL versus PEEP DECREMENTAL). Baseline PEEP is based in the standard of care PEEP used in the participant units. PEEP incremental value is based in transpulmonary pressure. Intervention : PEEP INCREMENTAL

Procedure: PEEP INCREMENTAL; Procedure: PEEP DECREMENTAL

PEEP_Titration_DECREMENTAL

EXPERIMENTAL

The investigators will compare 3 levels of PEEP (BASELINE versus PEEP INCREMENTAL versus PEEP DECREMENTAL). Baseline PEEP is based in the standard of care PEEP used in the participant units. PEEP decremental value is based in lung recruitment maneuver followed by a best compliance curve during PEEP decrements. Intervention :PEEP DECREMENTAL

Procedure: PEEP INCREMENTAL; Procedure: PEEP DECREMENTAL

Interventions

PEEP INCREMENTAL PROCEDURE

PEEP was progressively increased by steps of 2 cmH2O every 60 second until the end-expiratory transpulmonary pressure became positive between 0-2 cmH2O.

Also known as: PEEP_Titration

PEEP_Titration_DECREMENTAL; PEEP_Titration_INCREMENTAL

PEEP DECREMENTAL PROCEDURE

Lung recruitment maneuver (LRM) is a transitory and controlled increase in airway pressure to open collapsed alveoli. LRM is the first step of the PEEP DECREMENTAL method. After LRM, PEEP is systematically decreased, in small decrements, until the best respiratory system mechanics is identified.

Also known as: PEEP_Titration

PEEP_Titration_DECREMENTAL; PEEP_Titration_INCREMENTAL

Eligibility Criteria

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

You may qualify if:

• ICU admitted requiring intubation and mechanical ventilation
• BMI ≥ 35 kg/m2
• Waist circumference \> 88 cm (for women)
• Waist circumference \> 102 cm (for men)

You may not qualify if:

• Known presence of esophageal varices
• Recent esophageal trauma or surgery
• Severe thrombocytopenia (Platelets count ≤ 5,000/mm3)
• Severe coagulopathy (INR ≥ 4)
• Presence or history of pneumothorax
• Pregnancy
• Patients with poor oxygenation index (PaO2/FiO2\< 100 mmHg with at least 10 cmH2O of PEEP)
• Pacemaker and/or internal cardiac defibrillator
• Hemodynamic parameters: systolic blood pressure (SBP) \<100 mmHg and \>180 mmHg, or if SBP is between 100-180 mmHg on high dose of IV continuous infusion norepinephrine (\>20 μg per minute), or dobutamine (\>10 μg per minute), or dopamine (\>10 μg per Kg per minute), or epinephrine (\>10 μg per minute).

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (9)

• Akoumianaki E, Maggiore SM, Valenza F, Bellani G, Jubran A, Loring SH, Pelosi P, Talmor D, Grasso S, Chiumello D, Guerin C, Patroniti N, Ranieri VM, Gattinoni L, Nava S, Terragni PP, Pesenti A, Tobin M, Mancebo J, Brochard L; PLUG Working Group (Acute Respiratory Failure Section of the European Society of Intensive Care Medicine). The application of esophageal pressure measurement in patients with respiratory failure. Am J Respir Crit Care Med. 2014 Mar 1;189(5):520-31. doi: 10.1164/rccm.201312-2193CI.

  PMID: 24467647 BACKGROUND

• Behazin N, Jones SB, Cohen RI, Loring SH. Respiratory restriction and elevated pleural and esophageal pressures in morbid obesity. J Appl Physiol (1985). 2010 Jan;108(1):212-8. doi: 10.1152/japplphysiol.91356.2008. Epub 2009 Nov 12.

  PMID: 19910329 BACKGROUND

• Borges JB, Suarez-Sipmann F, Bohm SH, Tusman G, Melo A, Maripuu E, Sandstrom M, Park M, Costa EL, Hedenstierna G, Amato M. Regional lung perfusion estimated by electrical impedance tomography in a piglet model of lung collapse. J Appl Physiol (1985). 2012 Jan;112(1):225-36. doi: 10.1152/japplphysiol.01090.2010. Epub 2011 Sep 29.

  PMID: 21960654 BACKGROUND

• Reinius H, Jonsson L, Gustafsson S, Sundbom M, Duvernoy O, Pelosi P, Hedenstierna G, Freden F. Prevention of atelectasis in morbidly obese patients during general anesthesia and paralysis: a computerized tomography study. Anesthesiology. 2009 Nov;111(5):979-87. doi: 10.1097/ALN.0b013e3181b87edb.

  PMID: 19809292 BACKGROUND

• Victorino JA, Borges JB, Okamoto VN, Matos GF, Tucci MR, Caramez MP, Tanaka H, Sipmann FS, Santos DC, Barbas CS, Carvalho CR, Amato MB. Imbalances in regional lung ventilation: a validation study on electrical impedance tomography. Am J Respir Crit Care Med. 2004 Apr 1;169(7):791-800. doi: 10.1164/rccm.200301-133OC. Epub 2003 Dec 23.

  PMID: 14693669 BACKGROUND

• Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. doi: 10.1097/mcc.0b013e3283220e8c.

  PMID: 19186406 BACKGROUND

• Krishnan S, Schmidt GA. Acute right ventricular dysfunction: real-time management with echocardiography. Chest. 2015 Mar;147(3):835-846. doi: 10.1378/chest.14-1335.

  PMID: 25732449 BACKGROUND

• Vieillard-Baron A, Jardin F. Why protect the right ventricle in patients with acute respiratory distress syndrome? Curr Opin Crit Care. 2003 Feb;9(1):15-21. doi: 10.1097/00075198-200302000-00004.

  PMID: 12548024 BACKGROUND

• De Santis Santiago R, Teggia Droghi M, Fumagalli J, Marrazzo F, Florio G, Grassi LG, Gomes S, Morais CCA, Ramos OPS, Bottiroli M, Pinciroli R, Imber DA, Bagchi A, Shelton K, Sonny A, Bittner EA, Amato MBP, Kacmarek RM, Berra L; Lung Rescue Team Investigators. High Pleural Pressure Prevents Alveolar Overdistension and Hemodynamic Collapse in Acute Respiratory Distress Syndrome with Class III Obesity. A Clinical Trial. Am J Respir Crit Care Med. 2021 Mar 1;203(5):575-584. doi: 10.1164/rccm.201909-1687OC.

  PMID: 32876469 DERIVED

MeSH Terms

Conditions

Obesity; Respiratory Insufficiency; Heart Failure; Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Heart Diseases; Cardiovascular Diseases; Lung Diseases

Study Officials

• Robert Kacmarek, RRT, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Lorenzo Berra, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RRT, PhD

Model Details: Physiologic crossover study. There is no randomization. All participants will receive the same interventions in the same order.

Study Record Dates

• First Submitted: July 17, 2015
• First Posted: July 20, 2015
• Study Start: April 1, 2016
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2022
• Last Updated: November 17, 2020

Record last verified: 2020-11

Locations

US (1)