Open Lung Strategy in Critically Ill Morbid Obese Patients

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02503241
• Other study ID #: PRICESEOBESE
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2016
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Heart Failure
• Obesity
• Pulmonary Atelectasis
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency
• Respiratory Mechanics
• Right-Sided Heart Failure

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (8)

Akoumianaki E, Maggiore SM, Valenza F, Bellani G, Jubran A, Loring SH, Pelosi P, Talmor D, Grasso S, Chiumello D, Guérin 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. Review. — View Citation

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. — View Citation

Borges JB, Suarez-Sipmann F, Bohm SH, Tusman G, Melo A, Maripuu E, Sandström 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. — View Citation

Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. Review. — View Citation

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. Review. — View Citation

Reinius H, Jonsson L, Gustafsson S, Sundbom M, Duvernoy O, Pelosi P, Hedenstierna G, Fredén 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. — View Citation

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. Epub 2003 Dec 23. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intra-abdominal pressure	Changes in bladder pressure measured in mmHg.	Study time point: baseline
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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.
Other	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
Other	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.
Other	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
Other	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
Other	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
Other	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.
Other	Creatinine	Serum level of creatinine	48, 24h before AND 24, 48 and 72h after study procedures.
Other	Urinary output	Changes in urinary output (mL)	48, 24h before AND 24, 48 and 72h after study procedures.
Other	Fluid balance	Changes in fluid balance (mL)	48, 24h before AND 24, 48 and 72h after study procedures.
Other	Incidence of tracheostomy	Necessity of tracheostomy for prolonged ventilatory support among the study population	28 days after the performance of the study protocol
Other	Duration of mechanical ventilation	Number of days on mechanical ventilation	28 days after the performance of the study protocol
Other	Intensive care unit length of stay	Numbers of days spent in the intensive care	28 days after the performance of the study protocol
Other	Hospital length of stay	Numbers of days spent in the hospital	28 days after the performance of the study protocol
Primary	Respiratory System Elastance	Difference in Respiratory System Elastance measured in cmH2O/L	During study time points :baseline, PEEP incremental, PEEP decremental
Secondary	Lung mechanics - Compliance	Difference in respiratory system, lung and chest wall compliance measured in mL/cmH2O	Study time points: baseline, PEEP incremental, PEEP decremental
Secondary	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
Secondary	Survival	Incidence of death among the study population	28 days after the performance of the study protocol