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

NCT04141293 | Withdrawn

• 1 other identifier: 101/2017-SZTE
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ARDS, Human

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Changes in left and right ventricular volume (systolic ventricular interdependence)

  Approximately 3 minutes

• Changes in pulmonary air content

  Approximately 30 miniutes

• Changes in arterial oxygen content

  Approximately 5 minutes

• Changes in hemodynamic parameters (SV)

  35 minutes

• Changes in hemodynamic parameters (MAP)

  35 minutes

Study Arms (1)

Eligible patients

EXPERIMENTAL

Procedure: alveolar recruitment

Interventions

alveolar recruitment PROCEDURE

Alveolar recruitment is a procedure to re-expand collapsed lung regions with the transient increment in transpulmonary pressure.

Eligible patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

University of Szeged, Department of Anesthesiology and Intensive Therapy

Szeged, Csongrád megye, 6725, Hungary

Location

Related Publications (4)

• 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.

  PMID: 26682219 BACKGROUND

• 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.

  PMID: 25954744 BACKGROUND

• 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.

  PMID: 24597883 BACKGROUND

• 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: 22797452 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department

Study Record Dates

• First Submitted: August 30, 2017
• First Posted: October 28, 2019
• Study Start: August 1, 2017
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

HU (1)