Ventilator Hyperinflation With Increase of Inspiratory Time

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

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.

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation; Lung Infection
• Intervention / Treatment: Other: Ventilator hyperinflation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RJ
    • Campos Dos Goytacazes, RJ, Brazil, 28015150
      • Luciano M Chicayban

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mechanical ventilator hyperinflation; The VHI 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.	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.
No Intervention: Control; To perform the control (CTRL), the patients were only positioned and aspirated, without alteration in ventilatory parameters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Brazilian Institute of Higher Education of Censa
• Investigators: Principal Investigator: LUCIANO M CHICAYBAN, Brazilian Institute of Higher Education of Censa

Publications and helpful links

General Publications

• Chicayban LM. Acute effects of ventilator hyperinflation with increased inspiratory time on respiratory mechanics: randomized crossover clinical trial. Rev Bras Ter Intensiva. 2019 Oct 14;31(3):289-295. doi: 10.5935/0103-507X.20190052. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2017
• Primary Completion (Actual): August 12, 2017
• Study Completion (Actual): March 28, 2018

Study Registration Dates

• First Submitted: March 2, 2017
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 15, 2018

Study Record Updates

• Last Update Posted (Actual): August 15, 2018
• Last Update Submitted That Met QC Criteria: August 9, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Positive-Pressure Respiration; Physical Therapy Modalities,; Respiration Artificial,; Respiratory Care Units,; Respiratory Mechanics,
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: VHI + Tins

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No