Ventilator Hyperinflation With Increase of Inspiratory Time

Mechanical Ventilation Clinical Trial

Official title:

Ventilator Hyperinflation With Increase of Inspiratory Time on Respiratory Mechanics: A Randomized Crossover Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03630510
• Other study ID #: VHI + Tins
• Status: Completed
• Phase: N/A
• Start date: March 18, 2017
• Est. completion date: March 28, 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 investigators hypothesis is that the adjustment of the inspiratory time may optimize the distribution of ventilation and increase tidal volume, producing potential therapeutic effects on the displacement of secretions and respiratory mechanics. The objective of this study was To evaluate the effects of hyperinflation with the ventilator associated with increased inspiratory time on respiratory mechanics.

Description:

A randomized crossover clinical trial was conducted with 38 mechanically ventilated patients with pulmonary infection. The order of hyperinflation or control (without changes in parameters) was randomized. Hyperinflation was performed for 5 minutes in the controlled pressure ventilation mode, with progressive increases of 5cmH2O until reaching a maximum pressure of 35cmH2O, maintaining PEEP. After reaching 35cmH2O, the inspiratory time and respiratory rate were adjusted so that the inspiratory and expiratory flows reached the baseline, respectively. Static compliance (Cest, sr), total resistance (Rsr) and airway resistance (Rva), slow pressure drop (ΔP2) and peak expiratory flow (PEF) were assessed before (PRÉ), immediately after the maneuver (POSSimed) and after aspiration (POSPasp). Two-way ANOVA was used for repeated measurements with Tukey post-test, considering a significant p <0.05.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 28, 2018
• Est. primary completion date: August 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients under mechanical ventilation for more than 48h

• Mucus hypersecretion (defined as the need for suctioning < 2-h intervals)

Exclusion Criteria:

• Severe bronchospasm,

• Positive end expiratory pressure > 10cmH2O,

• PaO2-FiO2 relationship < 150,

• Mean arterial pressure < 60mmHg,

• Pleural effusion or pneumothorax undrained,

• Bronchopleural or tracheoesophageal fistula,

• Decompensated congestive heart failure.

Related Conditions & MeSH terms

• Lung Infection
• Mechanical Ventilation

Intervention

Other:
• Ventilator hyperinflation
The ventilator hyperinflation maneuver with inspiratory time adjustment was performed in the pressure controlled ventilation mode (PCV). The inspiratory pressure was increased gradually every 5 cmH2O until reaching a maximum pressure of 35 cmH2O, according to the tolerance of the patient determined by the absence of cough. PEEP remained unchanged throughout the study. After reaching a maximum pressure of 35 cmH2O (PCV + PEEP level), 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. The maneuver was performed for 5 min, followed by tracheal aspiration.

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	Static compliance of respiratory system	Compliance was assessed through the occlusion maneuver at the end of inspiration, considering tidal volume, plateau pressure and PEEP. Three measurements were taken at each moment, the mean being used.	Baseline (before), immediately after VHI and five minutes after aspiration
Primary	Total Resistance of respiratory system	The total resistance of the respiratory system was evaluated through the occlusion maneuver at the end of the inspiration, considering the resistive pressure, measured by the difference between the maximum plateau pressure. Three measurements were taken at each moment, the mean being used.	Baseline (before), immediately after VHI and five minutes after aspiration
Primary	Airway Resistance	The airway resistance was assessed by means of the occlusion maneuver at the end of the inspiration, considering the rapid fall of the pressure immediately after the occlusion, measured by the difference between the maximum pressure and P1. Three measurements were taken at each moment, the mean being used.	Baseline (before), immediately after VHI and five minutes after aspiration
Primary	Peak expiratory flow	The peak expiratory flow was evaluated through passive expiration, being considered the greatest value of the flow in the expiratory phase.	Baseline (before), immediately after VHI and five minutes after aspiration