Open Lung Strategy in Critically Ill Morbid Obese Patients

Open Lung Strategy in Critically Ill Morbid Obese Patients Lung Imaging and Heart-lung Interaction

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Pulmonary Atelectasis; Respiratory Insufficiency; Right-Sided Heart Failure; Respiratory Mechanics
• Intervention / Treatment: Procedure: PEEP INCREMENTAL; Procedure: PEEP DECREMENTAL

Detailed Description

Obese patients under mechanical ventilation are more likely to develop atelectasis as a consequence of the increased abdominal weight. Atelectasis is the primary responsible for respiratory insufficiency and impossibility to wean obese patients from respiratory support.

In a previous study we demonstrated the efficacy of the application of titrated PEEP levels following a recruitment maneuver in obese patients, i.e. improvement in respiratory mechanics and gas exchanges without negative hemodynamic effects.

The application of lung and heat imaging will allow us to quantitatively describe:

• Increase in aerated lung tissue (reduction of atelectasis)
• Reduction of over-inflation of the ventilated regions
• Recoupling of ventilation and perfusion
• Improvement in right heart function by reduction of right heart afterload

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEEP_Titration_INCREMENTAL; 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; PEEP was progressively increased by steps of 2 cmH2O every 60 second until the end-expiratory transpulmonary pressure became positive between 0-2 cmH2O.; Other Names: PEEP_Titration; Procedure: PEEP DECREMENTAL; 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.; Other Names: PEEP_Titration
Experimental: PEEP_Titration_DECREMENTAL; 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; PEEP was progressively increased by steps of 2 cmH2O every 60 second until the end-expiratory transpulmonary pressure became positive between 0-2 cmH2O.; Other Names: PEEP_Titration; Procedure: PEEP DECREMENTAL; 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.; Other Names: PEEP_Titration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory System Elastance	Difference in Respiratory System Elastance measured in cmH2O/L	During study time points :baseline, PEEP incremental, PEEP decremental

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung mechanics - Compliance	Difference in respiratory system, lung and chest wall compliance measured in mL/cmH2O	Study time points: baseline, PEEP incremental, PEEP decremental
Lung mechanics - Airway resistances	Difference in resistances of the airways measured as cmH2O/L/sec (Raw)	During study time points: baseline, PEEP incremental, PEEP decremental
Survival	Incidence of death among the study population	28 days after the performance of the study protocol

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-abdominal pressure	Changes in bladder pressure measured in mmHg.	Study time point: baseline
Electrical Impedance Tomography measurement: collapsed and overdistension	Percentage of lung tissue collapsed and over distended at different PEEP levels by analyzing pixel compliance ( variation in impedance divided by applied pressure during a respiratory cycle).	Study time points: baseline, PEEP incremental, PEEP decremental
Electrical Impedance Tomography measurement: distribution of ventilation	Difference in end-expiratory lung impedance as percentage estimating the distribution of ventilation among 4 horizontal regions of interest ( from non-dependent to dependent lung regions).	Study time points: baseline, PEEP incremental, PEEP decremental
Electrical Impedance Tomography measurement: lung perfusion	Differences in distribution in lung perfusion measured as regional percentage of the total cardiac output.	Study time points: baseline, PEEP incremental, PEEP decremental
Central venous pressure	Changes in central venous pressure (CVP, mmHg)	Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures
Gas Exchange - Oxygenation	Difference in oxygenation measured in mmHg of PaO2/FiO2	Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures
Gas Exchange - Arterial carbon dioxide	Difference in arterial carbon dioxide measured in mmHg (PaCO2)	Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures
Lung volumes - respiratory dead space	Difference in dead space fraction measured as the ratio of death volume over the total tidal volume (Vd/Vt)	Study time points: baseline, PEEP incremental, PEEP decremental.
Heart rate	Changes in heart rate (HR, bpm)	Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures
Blood pressure	Changes in invasive arterial blood pressures (BP, mmHg)	A) 48 and 24h before study procedures B)Study time points: baseline, PEEP incremental, PEEP decremental C)Follow up: 1, 2 , 24, 48 and 72 hours after study procedures.
Right heart function -Tricuspid Annular Plane Systolic Excursion (TAPSE)	Differences in TAPSE measured through two-dimensional transthoracic echocardiography (apical four-chamber view).	Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures
Right heart function - S'	Differences in the systolic excursion of the tricuspid annulus measured by tissue doppler imaging.	Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures
Right heart function - Tei index	Differences in global right ventricular function obtained from right ventricle tissue doppler imaging.	Study time points: baseline, PEEP incremental, PEEP decremental
Vasopressor requirement	Norepinephrine (mcg/kg/min), epinephrine (mcg/kg/min) , phenylephrine ( mcg/kg/min) and vasopressin (U / min)	48, 24h before AND 24, 48 and 72h after study procedures.
Creatinine	Serum level of creatinine	48, 24h before AND 24, 48 and 72h after study procedures.
Urinary output	Changes in urinary output (mL)	48, 24h before AND 24, 48 and 72h after study procedures.
Fluid balance	Changes in fluid balance (mL)	48, 24h before AND 24, 48 and 72h after study procedures.
Incidence of tracheostomy	Necessity of tracheostomy for prolonged ventilatory support among the study population	28 days after the performance of the study protocol
Duration of mechanical ventilation	Number of days on mechanical ventilation	28 days after the performance of the study protocol
Intensive care unit length of stay	Numbers of days spent in the intensive care	28 days after the performance of the study protocol
Hospital length of stay	Numbers of days spent in the hospital	28 days after the performance of the study protocol

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: July 17, 2015
• First Submitted That Met QC Criteria: July 17, 2015
• First Posted (Estimate): July 20, 2015

Study Record Updates

• Last Update Posted (Actual): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Situs Inversus; Heart Failure; Pulmonary Atelectasis; Respiratory Insufficiency; Dextrocardia
• Other Study ID Numbers: PRICESEOBESE