Ventilator Hyperinflation With Increase of Inspiratory Time

NCT ID: NCT03630510

Last Updated: 2018-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-18
• Study Completion Date: 2018-03-28

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.

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.

Conditions

Lung Infection; Mechanical Ventilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ventilator hyperinflation

Intervention Type: OTHER

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.

Control

To perform the control (CTRL), the patients were only positioned and aspirated, without alteration in ventilatory parameters.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brazilian Institute of Higher Education of Censa

OTHER

Sponsor Role: lead

Responsible Party

Luciano Matos Chicayban

Chefe do Laboratório de Análise de Disfunções Pneumofuncionais (LADPF)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

LUCIANO M CHICAYBAN

Role: PRINCIPAL_INVESTIGATOR

Brazilian Institute of Higher Education of Censa

Locations

Luciano M Chicayban

Campos dos Goytacazes, Rio de Janeiro, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 31618346 (View on PubMed)

Other Identifiers

VHI + Tins

Identifier Type: -

Identifier Source: org_study_id