NCT06698913

Brief Summary

The mortality of patients with acute respiratory distress syndrome (ARDS) remains high despite recent advances in lung-protective strategies and even after the overall improvement in intensive care (management of sepsis, hemodynamics, organ failure, and control of nosocomial infections). The use of mechanical ventilation (MV) plays a fundamental therapeutic role in this scenario. It allows for respiratory muscle rest, maintenance of oxygen transport to tissues, elimination of CO2 production, and finally, lung rest and protection in patients with excessive ventilatory demand. On the other hand, recent studies have also shown that MV can cause iatrogenic injury and inflammation in the lung parenchyma, imposing a significant mechanical energy load and dissipation in the lung parenchyma (mechanotransduction). This effect is more pronounced in patients with low lung compliance or in those receiving inadvertently high tidal volumes, resulting in high distending pressure. Thus, despite being life-saving in the short term, MV may perpetuate or exacerbate pre-existing lung injury. Various strategies have been proposed to aid in the ventilatory management of patients with ARDS. Among them, the use of higher PEEP values and the prone position have proven beneficial, especially when resulting in the stabilization of diseased alveoli or even promoting the recruitment of new alveolar units, associated with improved gas exchange. Both maneuvers, however, involve considerable risks: PEEP often causes impairments to venous return, and the prone position presents technical/logistical limitations for its widespread use, or even severe adverse effects during its implementation (ocular injury, accidental extubation, arrhythmias, catheter disconnection, etc.). The hypothesis of this study is that automated lateral decubitus positioning (performed by a rotational bed with proper patient support), guided by monitoring through Electrical Impedance Tomography (EIT), could replace or minimize the need for prone positioning or the need for higher PEEPs in critical patients, resulting in effective alveolar recruitment and improvements in gas exchange, compliance, and lung aeration without affecting the hemodynamic condition.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2021

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2024

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 21, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 21, 2024

Status Verified

September 1, 2024

Enrollment Period

4 years

First QC Date

October 23, 2024

Last Update Submit

November 19, 2024

Conditions

Respiratory InsufficiencyARDSPost Cardiac Surgery PatientsHypoxemic Respiratory Failure

Keywords

alveolar recruitmentpost cardiac surgerylateral positionHypoxemic Respiratory Failure

Outcome Measures

Primary Outcomes (9)

  • Lung Collapse

    Lung Collapse will be measured using the information provided by the EIT that uses the Costa method

    Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures.

  • Lung compliance

    Lung compliance (mL/cmH2O) will be measured using the information provided by the EIT that uses the movement equation

    Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures.

  • Oxygenation

    Oxigenation will be assessed using the partial pressure arterial oxygen/fraction inspired oxygen ratio. Partial pressure arterial oxygen measured in the blood sample at the of each step and the fraction inspired oxygen set during the blood sample collection will be used.

    Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures.

  • Shunt

    Oxygenation will be assessed using the partial pressure arterial oxygen/fraction inspired oxygen at 1 ratio and partial pressure arterial oxygen and partial pressure of oxygen in venous blood will be collected an calculated manual using the formula Q/Qt= (CcO2-Ca02)-(CcO1-CvO2) where CcO2 (Pulmonary end-capillary O2 content); CvO2 (Mixed venous O2 content); CaO2(Arterial O2 content).

    Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures.

  • Driving Pressure

    Driving Pressure (cmH2O) will be measured using the information provided by the EIT that uses the movement equation

    Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures.

  • End Expiratory Lung Volume

    will be measured using the information provided by the Electrical Tomography Impedance

    Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures.

  • Lung Hyperextension

    Lung Hyperextension (%) will be measured using the information provided by the EIT that uses the Costa method

    Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures.

  • Plateau Pressure

    Plateau Pressure( cmH2O) will be measured using the information provided by the EIT that uses the movement equation

    Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures.

  • Ventilatory Distribution

    will be measured using the information provided by the Electrical Tomography Impedance

    Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures.

Secondary Outcomes (10)

  • Stroke Volume

    the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization and the record throughout the duration of the protocol in the 20seconds of period of time

  • Diastolic Blood Pressure

    the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization and

  • Stroke Volume Index

    the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization and the record throughout the duration of the protocol in the 20seconds of period of time

  • Cardiac Index

    the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization and the record throughout the duration of the protocol in the 20seconds of period of time

  • Cardiac Output

    the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization and the record throughout the duration of the protocol in the 20seconds of period of time

  • +5 more secondary outcomes

Study Arms (2)

Lateral Positioning

EXPERIMENTAL

Sample1- Ventilator settings where adjusted with PEEP based on BMI, followed by a 2 cmH2O increase and 20 minutes in a lateral position at 30 degrees for lung recruitment for both sides. And at the end were subjected to an alveolar recruitment maneuver with pressure increases up to a plateau pressure of 45 cmH2O. Sample2- A recruitment maneuver followed by PEEP titration is performed, selecting the PEEP that is above the crossing point between the collapse and hyperdistension curves provided by EIT. And the the PEEP-ARDSNet will be selected according to the low PEEP-FIO2 table from the ARDSNet protocol. Observations are made at 4 and 24 hours, with PEEP at 24 hours adjusted to the level identified by EIT.

Procedure: Rotational Therapy

Control Group

NO INTERVENTION

Sample 1- The ventilator settings adjusted with PEEP based on BMI and remained in the supine position for the entire time. And at the end were subjected to an alveolar recruitment maneuver with pressure increases up to a plateau pressure of 45 cmH2O.Sample 2- A recruitment maneuver followed by PEEP titration is performed, selecting the PEEP that is above the crossing point between the collapse and hyperdistension curves provided by EIT. And the the PEEP-ARDSNet will be selected according to the low PEEP-FIO2 table from the ARDSNet protocol. Observations are made at 4 and 24 hours, with PEEP at 24 hours adjusted to the level identified by EIT

Interventions

Rotational TherapyPROCEDURE

Sample1- Ventilator settings where adjusted with PEEP based on BMI, followed by a 2 cmH2O increase and 20 minutes in a lateral position at 30 degrees for lung recruitment for both sides. And at the end were subjected to an alveolar recruitment maneuver with pressure increases up to a plateau pressure of 45 cmH2O. Sample2- A recruitment maneuver followed by PEEP titration is performed, selecting the PEEP that is above the crossing point between the collapse and hyperdistension curves provided by EIT. And the the PEEP-ARDSNet will be selected according to the low PEEP-FIO2 table from the ARDSNet protocol. Observations are made at 4 and 24 hours, with PEEP at 24 hours adjusted to the level identified by EIT.

Lateral Positioning

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sample 1-
  • Patients under mechanical ventilation
  • Immediate postoperative period of open-heart valve surgery and myocardial revascularization
  • PaO2/FiO2 ratio ≤ 250 mmHg (calculated from values obtained in arterial blood gas analysis)
  • Values collected with:
  • FiO2 ≥ 0.6 PEEP ≥ 8 cmH2O
  • Sample 2 -
  • Patients under controlled/assisted mechanical ventilation, not yet eligible for weaning
  • PaO2/FiO2 ratio \< 250 mmHg (calculated using arterial blood gas values)
  • Values collected with:
  • FiO2 = 0.6 PEEP \> 5 cmH2O
  • Acute condition onset less than 2 weeks ago
  • Mechanical ventilation duration of less than 1 week
  • Asymmetric ventilation distribution (65%/35%) on the functional map from Electrical Impedance Tomography (EIT) in the supine position
  • Both Samples:

You may not qualify if:

  • Need for norepinephrine ≥ 1 mcg/kg/min or mean arterial pressure ≤ 65 mmHg;
  • Cardiac arrhythmias or bleeding leading to hemodynamic instability;
  • Need for surgical revision and/or mechanical circulatory assistance;
  • Contraindication to hypercapnia, such as intracranial hypertension or acute coronary syndrome;
  • Neurological diseases or symptoms, such as a history of seizures;
  • Dependence on a cardiac pacemaker;
  • Air leakage through chest drains, undrained pneumothorax, or subcutaneous emphysema;
  • Previous lung disease or surgery, or use of home oxygen therapy;
  • Comorbidities with a life expectancy \&lt; 6 months;
  • Pulmonary artery systolic pressure \&gt; 45 mmHg;
  • Myocardial revascularization using the mammary artery;
  • Medical refusal for the patient\&#39;s participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, São Paulo, 05403-900, Brazil

Location

Related Publications (20)

  • Pereira SM, Tucci MR, Morais CCA, Simoes CM, Tonelotto BFF, Pompeo MS, Kay FU, Pelosi P, Vieira JE, Amato MBP. Individual Positive End-expiratory Pressure Settings Optimize Intraoperative Mechanical Ventilation and Reduce Postoperative Atelectasis. Anesthesiology. 2018 Dec;129(6):1070-1081. doi: 10.1097/ALN.0000000000002435.

    PMID: 30260897BACKGROUND

  • 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: 19186406BACKGROUND

  • Hewitt N, Bucknall T, Faraone NM. Lateral positioning for critically ill adult patients. Cochrane Database Syst Rev. 2016 May 12;2016(5):CD007205. doi: 10.1002/14651858.CD007205.pub2.

    PMID: 27169365BACKGROUND

  • Tongyoo S, Vilaichone W, Ratanarat R, Permpikul C. The effect of lateral position on oxygenation in ARDS patients: a pilot study. J Med Assoc Thai. 2006 Nov;89 Suppl 5:S55-61.

    PMID: 17718246BACKGROUND

  • Remolina C, Khan AU, Santiago TV, Edelman NH. Positional hypoxemia in unilateral lung disease. N Engl J Med. 1981 Feb 26;304(9):523-5. doi: 10.1056/NEJM198102263040906. No abstract available.

    PMID: 6779161BACKGROUND

  • Scholten EL, Beitler JR, Prisk GK, Malhotra A. Treatment of ARDS With Prone Positioning. Chest. 2017 Jan;151(1):215-224. doi: 10.1016/j.chest.2016.06.032. Epub 2016 Jul 8.

    PMID: 27400909BACKGROUND

  • Fessler HE, Talmor DS. Should prone positioning be routinely used for lung protection during mechanical ventilation? Respir Care. 2010 Jan;55(1):88-99.

    PMID: 20040127BACKGROUND

  • Puybasset L, Cluzel P, Chao N, Slutsky AS, Coriat P, Rouby JJ. A computed tomography scan assessment of regional lung volume in acute lung injury. The CT Scan ARDS Study Group. Am J Respir Crit Care Med. 1998 Nov;158(5 Pt 1):1644-55. doi: 10.1164/ajrccm.158.5.9802003.

    PMID: 9817720BACKGROUND

  • Pelosi P, D'Andrea L, Vitale G, Pesenti A, Gattinoni L. Vertical gradient of regional lung inflation in adult respiratory distress syndrome. Am J Respir Crit Care Med. 1994 Jan;149(1):8-13. doi: 10.1164/ajrccm.149.1.8111603.

    PMID: 8111603BACKGROUND

  • Malbouisson LM, Busch CJ, Puybasset L, Lu Q, Cluzel P, Rouby JJ. Role of the heart in the loss of aeration characterizing lower lobes in acute respiratory distress syndrome. CT Scan ARDS Study Group. Am J Respir Crit Care Med. 2000 Jun;161(6):2005-12. doi: 10.1164/ajrccm.161.6.9907067.

    PMID: 10852781BACKGROUND

  • Lai-Fook SJ, Rodarte JR. Pleural pressure distribution and its relationship to lung volume and interstitial pressure. J Appl Physiol (1985). 1991 Mar;70(3):967-78. doi: 10.1152/jappl.1991.70.3.967.

    PMID: 2033012BACKGROUND

  • Writing Group for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) Investigators; Cavalcanti AB, Suzumura EA, Laranjeira LN, Paisani DM, Damiani LP, Guimaraes HP, Romano ER, Regenga MM, Taniguchi LNT, Teixeira C, Pinheiro de Oliveira R, Machado FR, Diaz-Quijano FA, Filho MSA, Maia IS, Caser EB, Filho WO, Borges MC, Martins PA, Matsui M, Ospina-Tascon GA, Giancursi TS, Giraldo-Ramirez ND, Vieira SRR, Assef MDGPL, Hasan MS, Szczeklik W, Rios F, Amato MBP, Berwanger O, Ribeiro de Carvalho CR. Effect of Lung Recruitment and Titrated Positive End-Expiratory Pressure (PEEP) vs Low PEEP on Mortality in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1335-1345. doi: 10.1001/jama.2017.14171.

    PMID: 28973363BACKGROUND

  • Meade MO, Cook DJ, Guyatt GH, Slutsky AS, Arabi YM, Cooper DJ, Davies AR, Hand LE, Zhou Q, Thabane L, Austin P, Lapinsky S, Baxter A, Russell J, Skrobik Y, Ronco JJ, Stewart TE; Lung Open Ventilation Study Investigators. Ventilation strategy using low tidal volumes, recruitment maneuvers, and high positive end-expiratory pressure for acute lung injury and acute respiratory distress syndrome: a randomized controlled trial. JAMA. 2008 Feb 13;299(6):637-45. doi: 10.1001/jama.299.6.637.

    PMID: 18270352BACKGROUND

  • Terragni PP, Rosboch G, Tealdi A, Corno E, Menaldo E, Davini O, Gandini G, Herrmann P, Mascia L, Quintel M, Slutsky AS, Gattinoni L, Ranieri VM. Tidal hyperinflation during low tidal volume ventilation in acute respiratory distress syndrome. Am J Respir Crit Care Med. 2007 Jan 15;175(2):160-6. doi: 10.1164/rccm.200607-915OC. Epub 2006 Oct 12.

    PMID: 17038660BACKGROUND

  • Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. No abstract available.

    PMID: 24283226BACKGROUND

  • Amato MB, Barbas CS, Medeiros DM, Magaldi RB, Schettino GP, Lorenzi-Filho G, Kairalla RA, Deheinzelin D, Munoz C, Oliveira R, Takagaki TY, Carvalho CR. Effect of a protective-ventilation strategy on mortality in the acute respiratory distress syndrome. N Engl J Med. 1998 Feb 5;338(6):347-54. doi: 10.1056/NEJM199802053380602.

    PMID: 9449727BACKGROUND

  • Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.

    PMID: 10793162BACKGROUND

  • ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.

    PMID: 22797452BACKGROUND

  • Costa EL, Amato MB. The new definition for acute lung injury and acute respiratory distress syndrome: is there room for improvement? Curr Opin Crit Care. 2013 Feb;19(1):16-23. doi: 10.1097/MCC.0b013e32835c50b1.

    PMID: 23235543BACKGROUND

  • Matthay MA, Zemans RL, Zimmerman GA, Arabi YM, Beitler JR, Mercat A, Herridge M, Randolph AG, Calfee CS. Acute respiratory distress syndrome. Nat Rev Dis Primers. 2019 Mar 14;5(1):18. doi: 10.1038/s41572-019-0069-0.

    PMID: 30872586BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Marcelo BP, MD PhD

    University of Sao Paulo General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: In Sample 1, intervention group patients had ventilator settings adjusted with PEEP based on BMI, followed by a 2 cmH2O increase and 20 minutes in a lateral position at 30 degrees for lung recruitment, monitored by plethysmogram. PEEP was increased up to 4 cmH2O as needed. Afterward, patients returned to supine, and the process was repeated on the other side. The control group had similar ventilator settings but stayed supine. Both groups had an alveolar recruitment maneuver with increased pressures. In Sample 2, all patients underwent a 2-minute recruitment maneuver, followed by a 5-minute PEEP titration. The EIT-PEEP was identified and selected as the first PEEP above the crossing point of collapse and hyperdistension curves. Patients were then randomized, and PEEP was increased progressively based on randomization. The intervention group avoided traditional recruitment maneuvers, increasing PEEP gradually. This was followed by 4 hours of observation and a 24-hour follow-up
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2024

First Posted

November 21, 2024

Study Start

December 13, 2021

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

November 21, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)