Comparison Between Different Ventilator Hyperinflation Maneuvers

Ventilator Associated Pneumonia Clinical Trial

Official title:

Comparison Between Different Ventilator Hyperinflation Maneuvers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03631342
• Other study ID #: VHI Modality
• Status: Completed
• Phase: N/A
• Start date: March 18, 2017
• Est. completion date: May 23, 2018

Study information

• Verified date: August 2018
• Source: Brazilian Institute of Higher Education of Censa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The hyperinflation ventilator was performed in different modalities and ventilatory adjustments, with total pressure of 40cmH2O. The inspiratory volume, inspiratory time, mean airway pressure, inspiratory and expiratory flow, and bias flow were evaluated.

Description:

PURPOSE: To compare different ways of applying ventilator hyperinflation. METHODS: A randomized crossover clinical trial was performed with 30 patients (66.5 ± 17.3 years) with hypersecretion. The ventilator hyperinflation was performed in five ventilatory modalities for five minutes, with an interval of 2 hours, the order being determined by randomization: controlled ventilation at volume (VCV) with constant flow of 20 (VCV20) Lpm and 40 Lpm (VCV40), controlled ventilation pressure ventilation (PCV), controlled pressure ventilation associated with inspiratory time adjustment (PCV + Tins) and support pressure ventilation (PSV). In VCV mode, the volume was increased every 50mL, until reaching a maximum pressure of 40cmH2O. In the pressure controlled modes, the inspiratory pressure was increased every 5 cmH2O until the total pressure reached 40 cmH2O. The inspiratory time was adjusted so that the inspiratory flow reached the baseline. The following variables were evaluated: tidal volume, inspiratory time (Tins), mean airway pressure (Pmean), peak inspiratory flow (PIFR) and expiratory flow (PEFR), PIFR / PEFR and Bias Flow (PEFR-PIFR).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 23, 2018
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pulmonary infection

• Mechanically ventilated for more than 96 hours through pressure-assisted ventilation (PSV) or pressure-controlled ventilation (PCV)

• Static compliance between 30 and 70 mL/cmH2O

• PEEP between 5 and 8 cmH2O.

Exclusion Criteria:

• Hemodynamic instability

• Non-drained pleural effusion or pneumothorax

• Intracranial hypertension

• Bronchospasm

• Adult respiratory distress syndrome (ARDS)

• Decompensated congestive heart failure

Related Conditions & MeSH terms

• Infections, Respiratory
• Pneumonia
• Pneumonia, Ventilator-Associated
• Respiratory Tract Infections
• Ventilator Associated Pneumonia

Intervention

Other:
• VCV20
controlled volume ventilation mode under constant flow of 20 Lpm. The inspired volume was progressively increased until the Pmax reached 40cmH2O.
• VCV40
volume controlled ventilation mode under constant flow of 40 Lpm. The inspired volume was progressively increased until the Pmax reached 40cmH2O.
• PCV
controlled ventilation mode, 1 second inspiratory time. The inspiratory pressure was increased every 5 cmH2O, until reaching the maximum pressure of 40 cmH2O.
• PCV+Tins
controlled ventilation and inspiratory pressure was increased every 5 cmH2O until the maximum pressure was 40 cmH2O. The inspiratory time was gradually increased until the inspiratory flow reached the baseline. Concomitantly, the respiratory rate was decreased to allow the expiratory flow also to reach the baseline, to avoid self-PEEP.
• PSV
ventilatory mode with pressure support, with progressive increases of 5 cmH2O at inspiratory pressure, until reaching Pmax of 40 cmH2O. The expiratory sensitivity was adjusted by 25% for all patients.

Locations

Country	Name	City	State
Brazil	Luciano M Chicayban	Campos Dos Goytacazes	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Brazilian Institute of Higher Education of Censa

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inspiratory Volume	Inspiratory volume reached in each mode of ventilator hyperinflation, under a maximum pressure of 40cmH2O	Five minutes after the onset of intervention
Primary	Inspiratory time	inspiratory time necessary for the inspiratory flow to reach the baseline or according to the settings of each modality	Five minutes after the onset of intervention
Primary	Mean Pressure	airway mean pressure measured on the mechanical ventilator in 2 cycles	Five minutes after the onset of intervention
Primary	Peak Expiratory Flow	maximal expiratory flow in 2 cycles	Five minutes after the onset of intervention
Primary	Peak Inspiratory Flow	Maximal inspiratory flow in 2 cycles	Five minutes after the onset of intervention
Primary	PIFR/PEFR	Peak inspiratory to expiratory flow ratio	Five minutes after the onset of intervention
Primary	Bias Flow	Difference between peak inspiratory and expiratory flows	Five minutes after the onset of intervention