Clinical trial NCT03630510: Ventilator Hyperinflation With Increase of Inspiratory Time
Official title: Ventilator Hyperinflation With Increase of Inspiratory Time on Respiratory Mechanics: A Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Infection
Mechanical Ventilation
Keywords: Physical Therapy Modalities,
Respiration Artificial,
Respiratory Care Units,
Respiratory Mechanics,
Positive-Pressure Respiration
Lead sponsor: Brazilian Institute of Higher Education of Censa
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Static compliance of respiratory system
timeFrame: Baseline (before), immediately after VHI and five minutes after aspiration
measure: Total Resistance of respiratory system
timeFrame: Baseline (before), immediately after VHI and five minutes after aspiration
measure: Airway Resistance
timeFrame: Baseline (before), immediately after VHI and five minutes after aspiration
measure: Peak expiratory flow
timeFrame: Baseline (before), immediately after VHI and five minutes after aspiration
Secondary outcomes:
Other outcomes:
Locations:
city: Campos Dos Goytacazes
country: Brazil
facility: Luciano M Chicayban
state: RJ
Study officials:
affiliation: Brazilian Institute of Higher Education of Censa
name: LUCIANO M CHICAYBAN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.