Ventilator Hyperinflation With Increase of Inspiratory Time

Sponsor
Brazilian Institute of Higher Education of Censa (Other)
Overall Status
Completed
CT.gov ID
NCT03630510
Collaborator
(none)
38
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2
12.3
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Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Ventilator hyperinflation
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
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. The maneuver was performed for 5 min, followed by tracheal aspiration. To perform the control (CTRL), the patients were only positioned and aspirated, without alteration in ventilatory parameters.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. The maneuver was performed for 5 min, followed by tracheal aspiration. To perform the control (CTRL), the patients were only positioned and aspirated, without alteration in ventilatory parameters.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Ventilator Hyperinflation With Increase of Inspiratory Time on Respiratory Mechanics: A Randomized Crossover Trial
Actual Study Start Date :
Mar 18, 2017
Actual Primary Completion Date :
Aug 12, 2017
Actual Study Completion Date :
Mar 28, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Static compliance of respiratory system [Baseline (before), immediately after VHI and five minutes after aspiration]

    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.

  2. Total Resistance of respiratory system [Baseline (before), immediately after VHI and five minutes after aspiration]

    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.

  3. Airway Resistance [Baseline (before), immediately after VHI and five minutes after aspiration]

    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.

  4. Peak expiratory flow [Baseline (before), immediately after VHI and five minutes after aspiration]

    The peak expiratory flow was evaluated through passive expiration, being considered the greatest value of the flow in the expiratory phase.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Luciano M Chicayban Campos Dos Goytacazes RJ Brazil 28015150

Sponsors and Collaborators

  • Brazilian Institute of Higher Education of Censa

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Luciano Matos Chicayban, Chefe do Laboratório de Análise de Disfunções Pneumofuncionais (LADPF), Brazilian Institute of Higher Education of Censa
ClinicalTrials.gov Identifier:
NCT03630510
Other Study ID Numbers:
  • VHI + Tins
First Posted:
Aug 15, 2018
Last Update Posted:
Aug 15, 2018
Last Verified:
Aug 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Luciano Matos Chicayban, Chefe do Laboratório de Análise de Disfunções Pneumofuncionais (LADPF), Brazilian Institute of Higher Education of Censa
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 15, 2018