Ventilator Hyperinflation With Increase of Inspiratory Time

NCT03630510 | Completed DMC

• 1 other identifier: VHI + Tins
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Infection; Mechanical Ventilation

Keywords

Physical Therapy Modalities,; Respiration Artificial,; Respiratory Care Units,; Respiratory Mechanics,; Positive-Pressure Respiration

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

mechanical ventilator hyperinflation

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Ventilator hyperinflation 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.

mechanical ventilator hyperinflation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients under mechanical ventilation for more than 48h
• Mucus hypersecretion (defined as the need for suctioning \< 2-h intervals)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brazilian Institute of Higher Education of Censa: lead

Study Sites (1)

Luciano M Chicayban

Campos dos Goytacazes, Rio de Janeiro, 28015150, Brazil

Location

Related Publications (1)

• 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.

  PMID: 31618346 DERIVED

Study Officials

• LUCIANO M CHICAYBAN

  Brazilian Institute of Higher Education of Censa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chefe do Laboratório de Análise de Disfunções Pneumofuncionais (LADPF)

Model Details: 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.

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: August 15, 2018
• Study Start: March 18, 2017
• Primary Completion: August 12, 2017
• Study Completion: March 28, 2018
• Last Updated: August 15, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)