Heartrate Variability During Conventional and Variable Pressure Support Mechanical Ventilation

NCT03360968 | Unknown

• 1 other identifier: EK Nr: 1827/2017
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale Studies show that about a third of all postoperative complications are due to cardiovascular reasons. Furthermore it was shown that more than 50% of postoperative deaths are associated with severe cardiovascular incidents. After surgical interventions seriously ill patients are transferred to intensive care units and mechanically ventilated. However there is not much evidence about the impact of mechanical ventilation on the cardiovascular system and cardiovascular complications. Artificial mechanical ventilation greatly differs from physiological breathing. In contrast to physiological negative pressure ventilation of th lung, mechanical positive pressure ventilation can cause ventilator induced lung injuries. Furthermore a significant deterioration of lung-heart-interaction during mechanical ventilation is known. Relevance Mechanical ventilation leads to a decreased heartrate-variability, which has to be understood as increased stress on the cardiovascular system. Recently, a new ventilation mode called "variable pressure support ventilation" (VPSV) also known as "noisy pressure support ventilation". This new ventilation mode is similar to the ventilator mode "spontaneous-continuous positive airway pressure/pressure support" (SPN-CPAP), which is often used in a intensive care unit routine. Though VPSV differs through varying applicated pressure support and therefore tidal volumes. Therefore the new ventilation mode rather imitates physiological situation, since tidal volumes vary in physiological breathing, which has positive impact on heart-lung-interaction.

Conditions

Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (1)

• HF components

  High frequency (HF) components of heartrate-variability in ms²

  2 hours

Secondary Outcomes (3)

• SDNN

  2 hours

• HF-LF-ratio

  2 hours

• Tidal volumes

  2 hours

Other Outcomes (3)

• pH

  At minute 5, 55, 65 and 115 of the measurement

• PaO2

  At minute 5, 55, 65 and 115 of the measurement

• PaCO2

  At minute 5, 55, 65 and 115 of the measurement

Study Arms (2)

Treatment A-B

EXPERIMENTAL

Patient is treated with 1 hour SPN-CPAP/PS followed by 1 hour of Variable-PS ventilation mode

Procedure: Variable-PS; Procedure: SPN-CPAP/PS

Treatment B-A

EXPERIMENTAL

Patient is treated with 1 hour Variable-PS followed by 1 hour of SPN-CPAP/PS ventilation mode

Procedure: SPN-CPAP/PS; Procedure: Variable-PS

Interventions

Variable-PS PROCEDURE

Variable-PS mode switched on for 1 hour

Treatment A-B

SPN-CPAP/PS PROCEDURE

SPN-CPAP/PS mode switched on for 1 hour

Treatment A-B; Treatment B-A

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing therapy at an ICU; patients intubated and ventilated using SPN-CPAP/PS ventilator mode; patients with sinus rhythm in electrocardiogram

You may not qualify if:

• patients with active heart pace maker / defibrillator; patients with absent sinus rhythm in electrocardiogram; patients with known severe disease of autonomous nervous system

Sponsors & Collaborators

• Medical University of Vienna: lead
• Vienna University of Technology: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Study Officials

• Maximlian Schnetzinger, BSc

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: December 4, 2017
• Study Start: February 6, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 31, 2020
• Last Updated: April 8, 2020

Record last verified: 2020-04

Locations

AU (1)