The Effect of Preemptive APRV on Patients With High Risk for ARDS

NCT04699513 | Completed

• 1 other identifier: 2016/175
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

Brief Summary

Airway pressure release ventilation (APRV) is a mode of mechanical ventilation that alternates between two levels of continuous positive airway pressure (CPAP) support and allows spontaneous respiratory effort at either CPAP level. It is considered as an alternative, life-saving modality in patients with acute respiratory distress syndrome (ARDS) that struggle for oxygenation. Compared to the classical ventilation, APRV has been shown to provide lower peak pressure, better oxygenation, less circulatory loss, and better gas exchange without deteriorating the hemodynamic condition of the ARDS patient. This mode is believed to help to achieve the target of opening consolidated lung areas (recruitment) and to prevent repeated opening-closing of alveoli (decruitment). However, there is still insufficient and limited proof to support this hypothesis. Recently, it has been proposed that early use of protective mechanical ventilation with APRV could be used preemptively to prevent development of ARDS in high risk patients. In that study, APRV prevented clinical and histological lung injury by protecting alveolar epithelial integrity, preserving surfactant and alveolar stability, and reducing pulmonary edema. The primary purpose of the present study was to investigate whether early use of APRV as a lung-protecting strategy was superior to the conventional methods in a patient population with high risk of acute respiratory distress syndrome (ARDS).

Conditions

Acute Respiratory Distress Syndrome; Intensive Care Unit

Keywords

APRV; Intensive Care Unit

Outcome Measures

Primary Outcomes (2)

• ARDS

  Early use of APRV as a lung-protecting strategy was superior to the conventional methods in a patient population with high risk of acute respiratory distress syndrome (ARDS)

  2 year

• P/F ratio

  Affect of early using of APRV on P/F ratio, as a lung-protecting strategy was superior to the conventional methods in a patient population with high risk of acute respiratory distress syndrome (ARDS)

  2 year

Secondary Outcomes (7)

• Mortality

  2 year

• Oxygenation

  2 year

• Airway pressures

  2 year

• Sedation requirements

  2 year

• inotrope requirements

  2 year

Study Arms (2)

P-SIMV+PS group

EXPERIMENTAL

The reason behind using P-SIMV+PS as a conventional mode was that it is a pressure controlled mode like APRV.

Device: Mechanical Ventilation Mode (airway pressure release ventilation )

APRV group

EXPERIMENTAL

Airway pressure release ventilation (APRV) is a mode of mechanical ventilation that alternates between two levels of continuous positive airway pressure (CPAP) support and allows spontaneous respiratory effort at either CPAP level. It is considered as an alternative, life-saving modality in patients with acute respiratory distress syndrome (ARDS) that struggle for oxygenation.

Device: Mechanical Ventilation Mode (airway pressure release ventilation )

Interventions

Mechanical Ventilation Mode (airway pressure release ventilation ) DEVICE

Airway pressure release ventilation (APRV) is a mode of mechanical ventilation that alternates between two levels of continuous positive airway pressure (CPAP) support and allows spontaneous respiratory effort at either CPAP level. It is considered as an alternative, life-saving modality in patients with acute respiratory distress syndrome (ARDS) that struggle for oxygenation.

APRV group; P-SIMV+PS group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The study included patients who required invasive mechanical ventilation but was not initially diagnosed with ARDS 9, had a LIPS (Lung Injury Prediction Score) of \> 7, and have been staying in the ICU for more than 24 hours.

You may not qualify if:

• pregnancy
• intracranial hypertension (suspected or confirmed by measurement with external ventricular drainage catheter)
• severe chronic obstructive pulmonary disease or type II respiratory failure
• confirmed bronchopleural fistula
• documented barotrauma
• history of pneumonectomy

Sponsors & Collaborators

• Karadeniz Technical University: lead
• Ondokuz Mayıs University: collaborator

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Mehtap Pehlivanlar Küçük, MD

  Karadeniz Technical University, Faculty of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Intensivist

Model Details: a randomized controlled trial

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 7, 2021
• Study Start: May 1, 2016
• Primary Completion: October 30, 2018
• Study Completion: December 30, 2018
• Last Updated: January 7, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share