Cardioventilatory Coupling in Critically Ill Patients

NCT02286869 | Completed

• 1 other identifier: CaVeCo
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

This study measures the cardioventilatory coupling in critically ill patients during mechanical ventilation in controlled mode (pressure controlled) and in patient-driven mode (pressure support and neurally adjusted ventilatory assist).

Conditions

Critically Ill

Keywords

mechanical ventilation; autonomic nervous system; heart rate variability; cardioventilatory coupling

Outcome Measures

Primary Outcomes (1)

• to measure the cardioventilatory coupling in mechanically ventilated critically ill patients during three different mechanical ventilation settings

  to measure the cardioventilatory coupling in mechanically ventilated critically ill patients during three different modes of mechanical ventilation: (i) Pressure Controlled Ventilation, (ii)

  120 min

Secondary Outcomes (1)

• to measure the heart rate variability in mechanically ventilated critically ill patients during three different mechanical ventilation settings

  120 min

Study Arms (3)

Pressure Controlled Ventilation

EXPERIMENTAL

INTERVENTION: respiratory trial in pressure controlled mode: (i) the inspiratory pressure is set up to obtain the same tidal volume than baseline, (ii) the imposed respiratory rate is the same respiratory rate than baseline. The positive end expiratory pressure and fractional inspiratory oxygen are unchanged from the baseline. After an acclimation period of 10 min, electrocardiographic, arterial pressure and respiratory waves are recorded for 30 min.

Procedure: Three different mechanical ventilation modes

Pressure Support Ventilation

EXPERIMENTAL

INTERVENTION: respiratory trial in pressure support mode: (i) the inspiratory pressure is set up to obtain the same tidal volume than baseline, (ii) the inspiratory trigger is a flow-trigger with medium sensitivity. The positive end expiratory pressure and fractional inspiratory oxygen are unchanged from the baseline. In this ventilatory mode the respiratory rate is not imposed because is driven by the patient's respiratory effort. After an acclimation period of 10 min, electrocardiographic, arterial pressure and respiratory waves are recorded for 30 min.

Procedure: Three different mechanical ventilation modes

Neurally Adjusted Ventilatory Assist

EXPERIMENTAL

INTERVENTION: respiratory trial in Neurally Adjusted Ventilatory Assist (NAVA) mode: (i) NAVA-level (gain) is set up to obtain the same tidal volume than baseline, (ii) the inspiratory trigger is a neural trigger set at 0.5 microVolt. The positive end expiratory pressure and fractional inspiratory oxygen are unchanged from the baseline. In this ventilatory mode the respiratory rate is not imposed because is driven by the patient's respiratory effort. After an acclimation period of 10 min, electrocardiographic, arterial pressure and respiratory waves are recorded for 30 min.

Procedure: Three different mechanical ventilation modes

Interventions

Three different mechanical ventilation modes PROCEDURE

patients are randomly assigned to every arm. Baseline is the period immediatly before the study phase. The study phase is the sequence of three consecutive trials of different modes of mechanical ventilation. Every trial lasts 30 min plus 10 min of acclimation.

Neurally Adjusted Ventilatory Assist; Pressure Controlled Ventilation; Pressure Support Ventilation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients consecutively admitted to the mixed intensive care unit of the Luigi Sacco Hospital with (all the following):
• mechanical ventilation with an expected duration ≥ 48 hours
• acute respiratory failure due to ALI/ARDS or COPD exacerbation or pneumonia or severe sepsis/septic shock
• age between 18 and 75 years old

You may not qualify if:

• contraindications to esophageal tube positioning (i.e. esophageal varices, bleeding from upper enteric tract in the past 30 days)
• history of esophageal or gastric or thoracic surgery
• history of neuromuscular disease or stroke or head trauma
• history of thyroidal or adrenal dysfunction
• positive end expiratory pressure ≥ 10 cmH2O and/or inspiratory oxygen fraction ≥ 0.60, or intrinsic positive end expiratory pressure ≥ 8 cmH2O
• needing for neuromuscular blocking drugs administration
• patients unable to undergo to patient-driven mechanical ventilation mode (i.e. coma, excessive sedation)
• mechanical circulatory support (i.e. intra-aortic balloon, extracorporeal membrane oxygenation)
• norepinephrine ≥0.3 mcg/kg/min or epinephrine ≥0.05 mcg/kg/min or dobutamine ≥2.5 mcg/kg/min
• non sinus cardiac rhythm or ectopic beats exceeding ≥5% of normal sinus beats
• acute or chronic heart failure with reduced or preserved ejection fraction
• recent acute miocardial infarct ≤6 months
• recent recovery from respiratory failure or pneumonia or severe sepsis/septic shock ≤30 days
• therapy with beta-blockers

Sponsors & Collaborators

• ASST Fatebenefratelli Sacco: lead
• Tommaso Fossali: collaborator
• Stefano Guzzetti: collaborator
• Andrea Marchi: collaborator
• Alberto Porta: collaborator
• Beatrice Borghi: collaborator

Study Sites (2)

Luigi Sacco Hospital

Milan, 20157, Italy

Location

Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

Related Publications (11)

• Pagani M, Lombardi F, Guzzetti S, Rimoldi O, Furlan R, Pizzinelli P, Sandrone G, Malfatto G, Dell'Orto S, Piccaluga E, et al. Power spectral analysis of heart rate and arterial pressure variabilities as a marker of sympatho-vagal interaction in man and conscious dog. Circ Res. 1986 Aug;59(2):178-93. doi: 10.1161/01.res.59.2.178.

  PMID: 2874900 BACKGROUND

• Nollo G, Faes L, Porta A, Antolini R, Ravelli F. Exploring directionality in spontaneous heart period and systolic pressure variability interactions in humans: implications in the evaluation of baroreflex gain. Am J Physiol Heart Circ Physiol. 2005 Apr;288(4):H1777-85. doi: 10.1152/ajpheart.00594.2004. Epub 2004 Dec 16.

  PMID: 15604132 BACKGROUND

• Rosenblum MG, Cimponeriu L, Bezerianos A, Patzak A, Mrowka R. Identification of coupling direction: application to cardiorespiratory interaction. Phys Rev E Stat Nonlin Soft Matter Phys. 2002 Apr;65(4 Pt 1):041909. doi: 10.1103/PhysRevE.65.041909. Epub 2002 Mar 28.

  PMID: 12005875 BACKGROUND

• Porta A, Baselli G, Lombardi F, Montano N, Malliani A, Cerutti S. Conditional entropy approach for the evaluation of the coupling strength. Biol Cybern. 1999 Aug;81(2):119-29. doi: 10.1007/s004220050549.

  PMID: 10481240 BACKGROUND

• Porta A, Guzzetti S, Montano N, Furlan R, Pagani M, Malliani A, Cerutti S. Entropy, entropy rate, and pattern classification as tools to typify complexity in short heart period variability series. IEEE Trans Biomed Eng. 2001 Nov;48(11):1282-91. doi: 10.1109/10.959324.

  PMID: 11686627 BACKGROUND

• Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.

  PMID: 8598068 BACKGROUND

• Galletly DC, Larsen PD. Inspiratory timing during anaesthesia: a model of cardioventilatory coupling. Br J Anaesth. 2001 Jun;86(6):777-88. doi: 10.1093/bja/86.6.777.

  PMID: 11573583 BACKGROUND

• Giardino ND, Glenny RW, Borson S, Chan L. Respiratory sinus arrhythmia is associated with efficiency of pulmonary gas exchange in healthy humans. Am J Physiol Heart Circ Physiol. 2003 May;284(5):H1585-91. doi: 10.1152/ajpheart.00893.2002. Epub 2003 Jan 23.

  PMID: 12543637 BACKGROUND

• Hayano J, Yasuma F, Okada A, Mukai S, Fujinami T. Respiratory sinus arrhythmia. A phenomenon improving pulmonary gas exchange and circulatory efficiency. Circulation. 1996 Aug 15;94(4):842-7. doi: 10.1161/01.cir.94.4.842.

  PMID: 8772709 BACKGROUND

• Schmidt M, Demoule A, Cracco C, Gharbi A, Fiamma MN, Straus C, Duguet A, Gottfried SB, Similowski T. Neurally adjusted ventilatory assist increases respiratory variability and complexity in acute respiratory failure. Anesthesiology. 2010 Mar;112(3):670-81. doi: 10.1097/ALN.0b013e3181cea375.

  PMID: 20179505 BACKGROUND

• Guzzetti S, Borroni E, Garbelli PE, Ceriani E, Della Bella P, Montano N, Cogliati C, Somers VK, Malliani A, Porta A. Symbolic dynamics of heart rate variability: a probe to investigate cardiac autonomic modulation. Circulation. 2005 Jul 26;112(4):465-70. doi: 10.1161/CIRCULATIONAHA.104.518449. Epub 2005 Jul 18.

  PMID: 16027252 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardioventilatory coupling in critically ill

Study Record Dates

• First Submitted: November 4, 2014
• First Posted: November 10, 2014
• Study Start: September 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 1, 2017

Record last verified: 2017-07

Locations

IT (2)