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Ventilator Hyperinflation With Increase of Inspiratory Time

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ClinicalTrials.gov Identifier: NCT03630510
Recruitment Status : Completed
First Posted : August 15, 2018
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Luciano Matos Chicayban, Brazilian Institute of Higher Education of Censa

Study Description
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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
Lung Infection Mechanical Ventilation Other: Ventilator hyperinflation Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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.
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 : March 18, 2017
Actual Primary Completion Date : August 12, 2017
Actual Study Completion Date : March 28, 2018
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Static compliance of respiratory system [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630510


Locations
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Brazil
Luciano M Chicayban
Campos Dos Goytacazes, RJ, Brazil, 28015150
Sponsors and Collaborators
Brazilian Institute of Higher Education of Censa
Investigators
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Principal Investigator: LUCIANO M CHICAYBAN Brazilian Institute of Higher Education of Censa
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: August 15, 2018    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Luciano Matos Chicayban, Brazilian Institute of Higher Education of Censa:
Physical Therapy Modalities,
Respiration Artificial,
Respiratory Care Units,
Respiratory Mechanics,
Positive-Pressure Respiration
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes