Hemodynamic Effects of Changes in Transpulmonary Pressure During Recruitment Maneuver in Patients Under Pressure Supported Mechanical Ventilation

Hemodynamic Effects of Changes in Transpulmonary Pressure During Recruitment Maneuver in Patients Under Pressure Support Mechanical Ventilation

According to the anatomical proximity of the heart temporarily elevated intrathoracic pressures may have direct and indirect effects on the cardiovascular system. Undesirable hemodynamic effects of a recruitment maneuver primarily arise from the transiently increased airway pressure, manifesting in decreased right heart filling, increased pulmonary vascular resistance, a drop in left ventricular systolic transmural pressure, right and left heart ventricular interactions and subsequent changes in cardiac index. These effects can be more pronounced in patients suffering from ARDS, a condition commonly accompanied by hemodynamic instability. The complex pathophysiological changes account for why routine intensive care monitoring, such as invasive arterial blood pressure or central venous pressure monitoring is insufficient to follow hemodynamic changes under recruitment maneuver.

Previous studies by the same research team confirmed that the alveolar recruitment maneuver improves oxygenation in patients with moderate-to-severe hypoxemic respiratory failure under pressure supported ventilation. Following recruitment maneuver, arterial oxygenation increased in 74 % of all patients. However, there is lack of information regarding the actual degree of changes in transpulmonary pressure and the consequent hemodynamic alterations.

The primary aim of the study is to evaluate precisely the transpulmonary pressure changes during recruitment in patients with severe hypoxemic respiratory failure ventilated in pressure support mode following insertion of a balloon-catheter into the esophagus. In the meantime, hemodynamic changes are monitored by PiCCO and transthoracic echocardiography, and lung field aeration by electric impedance tomography.

Study Overview

• Status: Withdrawn
• Conditions: ARDS, Human
• Intervention / Treatment: Procedure: alveolar recruitment

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Csongrád
    • Szeged, Csongrád, Hungary, 6725
      • University of Szeged, Department of Anesthesiology and Intensive Therapy

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• orotracheal intubation
• pressure supported ventilation
• moderate-to-severe hypoxemic respiratory failure according to ARDS Berlin Criteria Moderate: 100 Hgmm ≤ PaO2/FiO2 ≤ 200 Hgmm, PEEP ≥ 5 cmH2O Severe: PaO2/FiO2 ≤ 100 Hgmm, PEEP ≥ 5 cmH2O

Exclusion Criteria:

• age < 18 years
• pregnancy
• previous pulmonary resection, pulmonectomy
• clinically verified, end-stage COPD
• severe hemodynamic instability (i.e. refractory shock to vasopressors)
• severe emphysema and/or spontaneous pneumothorax in past medical history
• contraindications of a balloon-catheter (e.g. esophageal abscess, esophageal perforation, esophageal diverticulosis, esophagus tumor, esophagus varix, recent esophagus or gastric surgery, severe coagulopathy)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eligible patients	Procedure: alveolar recruitment; Alveolar recruitment is a procedure to re-expand collapsed lung regions with the transient increment in transpulmonary pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of transpulmonary pressure and hemodynamic changes during alveolar recruitment	Changes in transpulmonary pressure during alveolar recruitment will be compared to the subsequent hemodynamic alterations	Approximately 35 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in left and right ventricular volume (systolic ventricular interdependence)	Left ventricular end-systolic eccentricity index will be assessed by transthoracal echocardiogarphy and will be compared with transpulmonary pressure alterations.	Approximately 3 minutes
Changes in pulmonary air content	Changes in pulmonary atelectasis will be assessed by electrical impedance tomography (EIT) - mean impedance variation in % and will be compared with arterial oxygen content.	Approximately 30 miniutes
Changes in arterial oxygen content	Pre- and post-recruitment arterial oxygenation (PaO2 mmHg) will be measured by blood gas machine and will be compared to EIT measurements.	Approximately 5 minutes
Changes in hemodynamic parameters (SV)	Changes in stroke volume (ml)	35 minutes
Changes in hemodynamic parameters (MAP)	Changes in mean arterial pressure (mmHg)	35 minutes
Changes in hemodynamic parameters (HR)	Changes in heart rate (1/min)	35 minutes
Changes in hemodynamic parameters (CI)	Changes in cardiac index (l/min/2m)	35 minutes

Collaborators and Investigators

• Sponsor: Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged

Publications and helpful links

General Publications

• Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2014 Mar 6;370(10):980. doi: 10.1056/NEJMc1400293. No abstract available.
• Lovas A, Szakmany T. Haemodynamic Effects of Lung Recruitment Manoeuvres. Biomed Res Int. 2015;2015:478970. doi: 10.1155/2015/478970. Epub 2015 Nov 22.
• Lovas A, Nemeth MF, Trasy D, Molnar Z. Lung recruitment can improve oxygenation in patients ventilated in continuous positive airway pressure/pressure support mode. Front Med (Lausanne). 2015 Apr 21;2:25. doi: 10.3389/fmed.2015.00025. eCollection 2015.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Estimated): November 1, 2021
• Study Completion (Estimated): November 1, 2021

Study Registration Dates

• First Submitted: August 30, 2017
• First Submitted That Met QC Criteria: October 25, 2019
• First Posted (Actual): October 28, 2019

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 18, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Respiratory Distress Syndrome
• Other Study ID Numbers: 101/2017-SZTE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No