Respiratory Mechanics Assessment at Different Head of the Bed Elevations in Mechanically Ventilated Patients

Respiratory Failure Clinical Trial

Official title:

Respiratory Mechanics Assessment at Different Head of the Bed Elevations in Mechanically Ventilated Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06409897
• Other study ID #: 68464523.9.0000.0068
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: April 1, 2025

Study information

• Verified date: April 2024
• Source: University of Sao Paulo General Hospital
• Contact: Marcelo BP Amato, MD, PhD
• Phone: 3061-7361
• Email: marcelo.amato[@]hc.fm.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The effects of different degrees of head-of-bed elevation on respiratory mechanics are poorly explored in the literature, and no study has investigated such effects using electrical impedance tomography, esophageal and gastric balloons to identify the ideal angle for optimizing respiratory mechanics. The hypothesis is that there is a optimal degree for the respiratory mechanics.

Description:

Respiratory mechanics and regional ventilation will be monitored using electrical impedance tomography (Enlight 2100, Timpel Medical®, Brazil) . Esophageal and gastric pressures will be obtained through esophageal and gastric balloon catheters (Nutrivent®) (validation concerning to modified Baydur maneuver - slope delta esophageal pressure/delta airway pressure (0,8-1,2). We are using the hardware Pneumodrive (Biônica, Recife, Brazil) to record and store the esophageal, gastric and airway pressures, these data will be analyzed using LabVIEW 7.1 (Pneumobench).

Initially, patients will be positioned at 0 degrees of head-of-bed elevation, and after stabilization of the plethysmogram, data from electrical impedance tomography, hemodynamics, and arterial blood gas will be collected (arterial blood will be drawn by a nurse or physician). Sequentially and in the same manner, the bed will be adjusted to 10, 20, 30, and 40 degrees (the same data will be collected, except for the arterial blood sample, which will only be collected at the 40-degree elevation). Then, an alveolar recruitment maneuver will be performed, followed by a PEEP titration with 10-degree of head-of-bed elevation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients under invasive mechanical ventilation, intubated due to respiratory failure

Exclusion Criteria:

• Hemodynamics instability, contraindication for monitoring with esophageal and gastric catheters, and Electrical impedance tomography, no authorization of medical team of the intensive care unit, and contraindication for lung recruitment maneuver

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• Sequencial increasing of head of the bed elevation and alveolar recruitment maneuver followed by a PEEP titration with 10° of head of the elevation
Patients will be sequentially positioned at 0, 10, 20, 30, and 40 degrees of head-of-bed elevation. An alveolar recruitment maneuver will be performed. For patients with body mass index = 30 kg/m^2, the maneuver will be conducted in pressure control mode, pressure control = 15 cmH2O, respiratory rate = 20 breaths per minute, and the PEEP will be increased in steps of 5 up to 30 cmH2O. For patients with body mass index > 30, the PEEP will be increased up to 35. Then, a PEEP titration will be performed, tidal volume = 5 mL/Kg, respiratory rate = 25 breaths per minute, and the PEEP will be decreased from 24 down to 4 cmH2O in steps of 2 cmH2O with 30 seconds in each PEEP level. The PEEP titration software of Enlight 2100 will be used to determine the ideal PEEP, defined as the PEEP level with a collapse less than 5%. The alveolar recruitment maneuver will be performed again to reopen the lungs. Then, data will be collected, as with the 0 and 40-degree steps, with ideal PEEP.

Locations

Country	Name	City	State
Brazil	Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (20)

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. — View Citation

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. — View Citation

Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639. — View Citation

Briel M, Meade M, Mercat A, Brower RG, Talmor D, Walter SD, Slutsky AS, Pullenayegum E, Zhou Q, Cook D, Brochard L, Richard JC, Lamontagne F, Bhatnagar N, Stewart TE, Guyatt G. Higher vs lower positive end-expiratory pressure in patients with acute lung injury and acute respiratory distress syndrome: systematic review and meta-analysis. JAMA. 2010 Mar 3;303(9):865-73. doi: 10.1001/jama.2010.218. — View Citation

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

Dellamonica J, Lerolle N, Sargentini C, Hubert S, Beduneau G, Di Marco F, Mercat A, Diehl JL, Richard JC, Bernardin G, Brochard L. Effect of different seated positions on lung volume and oxygenation in acute respiratory distress syndrome. Intensive Care Med. 2013 Jun;39(6):1121-7. doi: 10.1007/s00134-013-2827-x. Epub 2013 Jan 24. — View Citation

Galiatsou E, Kostanti E, Svarna E, Kitsakos A, Koulouras V, Efremidis SC, Nakos G. Prone position augments recruitment and prevents alveolar overinflation in acute lung injury. Am J Respir Crit Care Med. 2006 Jul 15;174(2):187-97. doi: 10.1164/rccm.200506-899OC. Epub 2006 Apr 27. — View Citation

Guner CK, Kutluturkan S. Role of head-of-bed elevation in preventing ventilator-associated pneumonia bed elevation and pneumonia. Nurs Crit Care. 2022 Sep;27(5):635-645. doi: 10.1111/nicc.12633. Epub 2021 Apr 21. — View Citation

Mahran GSK, Abd-Elshafy SK, Abd El Neem MM, Sayed JA. The effect of reference position versus right lateral position on the intra-abdominal pressure in mechanically ventilated patients. Journal of Nursing Education and Practice. 2018;8(6).

Marfil-Gomez RM, Garcia-Mayor S, Morales-Asencio JM, Gomez-Gonzalez AJ, Morilla-Herrera JC, Moya-Suarez AB, Aranda-Gallardo M, Rincon-Lopez T, Lupianez-Perez I. Pressure levels in the trochanter area according to repositioning at different degrees of inclination in healthy subjects. J Tissue Viability. 2020 May;29(2):125-129. doi: 10.1016/j.jtv.2020.02.003. Epub 2020 Feb 13. — View Citation

Marrazzo F, Spina S, Forlini C, Guarnieri M, Giudici R, Bassi G, Bastia L, Bottiroli M, Fumagalli R, Langer T. Effects of Trunk Inclination on Respiratory Mechanics in Patients with COVID-19-associated Acute Respiratory Distress Syndrome: Let's Always Report the Angle! Am J Respir Crit Care Med. 2022 Mar 1;205(5):582-584. doi: 10.1164/rccm.202110-2360LE. No abstract available. — View Citation

McBeth PB, Zygun DA, Widder S, Cheatham M, Zengerink I, Glowa J, Kirkpatrick AW. Effect of patient positioning on intra-abdominal pressure monitoring. Am J Surg. 2007 May;193(5):644-7; discussion 647. doi: 10.1016/j.amjsurg.2007.01.013. — View Citation

Mutoh T, Guest RJ, Lamm WJ, Albert RK. Prone position alters the effect of volume overload on regional pleural pressures and improves hypoxemia in pigs in vivo. Am Rev Respir Dis. 1992 Aug;146(2):300-6. doi: 10.1164/ajrccm/146.2.300. — View Citation

Richard JC, Maggiore SM, Mancebo J, Lemaire F, Jonson B, Brochard L. Effects of vertical positioning on gas exchange and lung volumes in acute respiratory distress syndrome. Intensive Care Med. 2006 Oct;32(10):1623-6. doi: 10.1007/s00134-006-0299-y. Epub 2006 Aug 1. — View Citation

Roldan R, Rodriguez S, Barriga F, Tucci M, Victor M, Alcala G, Villamonte R, Suarez-Sipmann F, Amato M, Brochard L, Tusman G. Sequential lateral positioning as a new lung recruitment maneuver: an exploratory study in early mechanically ventilated Covid-19 ARDS patients. Ann Intensive Care. 2022 Feb 12;12(1):13. doi: 10.1186/s13613-022-00988-9. — View Citation

Samimian S, Ashrafi S, Khaleghdoost Mohammadi T, Yeganeh MR, Ashraf A, Hakimi H, Dehghani M. The Correlation between Head of Bed Angle and Intra-Abdominal Pressure of Intubated Patients; a Pre-Post Clinical Trial. Arch Acad Emerg Med. 2021 Mar 6;9(1):e23. doi: 10.22037/aaem.v9i1.1065. eCollection 2021. — View Citation

Selickman J, Crooke PS, Tawfik P, Dries DJ, Gattinoni L, Marini JJ. Paradoxical Positioning: Does "Head Up" Always Improve Mechanics and Lung Protection? Crit Care Med. 2022 Nov 1;50(11):1599-1606. doi: 10.1097/CCM.0000000000005631. Epub 2022 Jul 21. — View Citation

Vasquez DG, Berg-Copas GM, Wetta-Hall R. Influence of semi-recumbent position on intra-abdominal pressure as measured by bladder pressure. J Surg Res. 2007 May 15;139(2):280-5. doi: 10.1016/j.jss.2006.10.023. Epub 2006 Dec 8. — View Citation

Villar J, Kacmarek RM, Perez-Mendez L, Aguirre-Jaime A. A high positive end-expiratory pressure, low tidal volume ventilatory strategy improves outcome in persistent acute respiratory distress syndrome: a randomized, controlled trial. Crit Care Med. 2006 May;34(5):1311-8. doi: 10.1097/01.CCM.0000215598.84885.01. — View Citation

Wang L, Li X, Yang Z, Tang X, Yuan Q, Deng L, Sun X. Semi-recumbent position versus supine position for the prevention of ventilator-associated pneumonia in adults requiring mechanical ventilation. Cochrane Database Syst Rev. 2016 Jan 8;2016(1):CD009946. doi: 10.1002/14651858.CD009946.pub2. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory system compliance	Respiratory system compliance (mL/cmH2O) will be measured using electrical impedance tomography monitoring (Enlight 2100, Timpel Medical®, Brazil).	At 0, 10, 20, 30, 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation
Primary	Lung compliance	Lung compliance (mL/cmH2O) will be measured offline using the esophageal pressure tracings. By knowing the respiratory system and chest wall compliance, the lung compliance will be calculated. (1/respiratory system compliance = 1/chest wall compliance + 1/lung compliance)	At 0, 10, 20, 30, 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation
Primary	Chest wall compliance	Chest wall compliance (mL/cmH2O) will be measured offline using the esophageal pressure tracings.; Chest wall compliance = tidal volume / delta esophageal pressure	At 0, 10, 20, 30, 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation
Secondary	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.	At 0 and 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation
Secondary	Pressure between patient skin surface and the mattress	ForeSite PT (XSENSOR Technology Corporation, Patient Monitoring System) will be used to measure the pressure between patient's skin surface and the mattress. A monitor connected to this sensor provides continuous pressure monitoring, and the data will exported for subsequent offline analysis of the sacral and occipital regions.	At 0, 10, 20, 30, 40-degrees of head-of-bed elevation
Secondary	Hemodynamics satefy of keeping low degrees of head of the elevation	Arterial blood pressure provided by the multiparameter monitor. Data will be noted in each degree.	At 0, 10, 20, 30, 40-degrees of head-of-bed elevation
Secondary	Gastric pressure	Gastric pressure will be measured offline using the gastric pressure tracings.	At 0 and 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation