Compare Between APRV and Bipap Ventilation in ARDS Patients

Comparative Study Between Airway Pressure Release Ventilation and Bi-level Positive Airway Pressure Ventilation in Acute Respiratory Distress Syndrome

To evaluate whether early use of airway pressure release ventilation would improve oxgyenation , improve lung compliance and shorten the time of mechanical ventilation compared to BIPAP ventilation in ARDS patients

Study Overview

• Status: Not yet recruiting
• Conditions: ARDS; ARDS: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Other: mechanical ventilation (MV); Other: mechanical ventilation (MV)

Detailed Description

Acute respiratory distress syndrome (ARDS) is an extremely dangerous lung condition that leads to low blood oxygen levels, and is commonly caused by sepsis, pneumonia, aspiration, and trauma. Despite great improvements in mechanical ventilation in recent years, the mortality rate of ARDS is still high. Low tidal volume ventilation (LTVV), optimum positive end-expiratory pressure, permissive hypercapnia, lung recruitment, and the prone position are common treatments for ARDS .

Lung recruitment maneuvers (LRMs) are a common element of the "open lung" approach to lung-protective ventilation. Given that atelectasis increases alveolar stress and strain during tidal ventilation, LRMs may mitigate ventilator-induced lung injury (VILI) and reduce the considerable risk of death for patients with ARDS. However, the transient application of high airway pressures may impair cardiovascular function and traumatize the pulmonary epithelium (barotrauma). Consequently, the use of LRMs is controversial .

APRV and BIPAP are modes of mechanical ventilation that allow unrestricted spontaneous breathing independent of ventilator cycling, using an active expiratory valve. Both modes are pressure-limited. Ventilation occurs via the time-cycled switching between two set pressure levels .

Bilevel positive airway pressure is a partial support mode that employs pressure-controlled, time-cycled ventilation set at two levels of continuous positive airway pressure (CPAP) with unrestricted spontaneous breathing. Which can occur at any phase of the mechanical ventilatory cycle. Bilevel positive airway pressure is able to modulate the inspiratory effort by modifying the frequency of controlled breaths .

In traditional biphasic ventilation, the inspiratory to expiratory ratio is not inverse. This ratio often distinguishes biphasic ventilation from APRV. Ventilator parameters set in this mode include the inspiratory pressure limit (Phigh), inspiratory time (Thigh), PEEP level (Plow), rate, and fraction of inspired oxgyen (FiO2). On some ventilators, pressure support may be added to augment the patient's spontaneous breaths .

Airway pressure release ventilation (APRV) is defined as a continuous positive airway pressure (CPAP) with a brief intermittent release phase based on the open lung concept; it also perfectly fits the ARDS treatment principle. Despite this, APRV has not been widely used in the past, rather only as a rescue measure for ARDS patients who are difficult to oxygenate .

APRV is a form of pressure controlled intermittent mandatory ventilation that is designed to allow unrestricted spontaneous breathing through the breath cycle, especially during Timehigh (Thigh).it is also applied using I:E ratios much greater than 1:1 or inverse ratio ventilation, usually relying on short expiratory times and gas trapping to maintain end-expiratory lung volume. APRV improve oxygenation and decrease the amount of alveolar derecruitment during the Timelow (Tlow) .

All preexisting data did not address the question for which APRV was being promoted, is that APRV should be used as initial mode of mechanical ventilation for patients with ARDS. Multiple reports and studies in animals and humans have not helped answer this question. Not only is there paucity in the number of high quality trials in humans, but there is a lack of consistency on how APRV is applied .

Over recent years, with an increased understanding of the pathophysiology of ARDS, APRV has been re-proposed to improve patient prognosis. Nevertheless, this mode is still not routinely used in ARDS patients .

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 .

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rana A Mohamed, MSc; Phone Number: +20 1020511666; Email: d.rana386@yahoo.com
• Study Contact Backup: Name: Ahmed F Abdelraouf, PhD; Phone Number: +20 1024174200; Email: awinnersid30@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who meet all ARDS criteria (according to Berlin definition).
• Patients who had received endotracheal intubation and mechanical ventilation for <48h prior to inclusion.

Exclusion Criteria:

• Age below 18 years and above 65 years.
• Presence of significant chronic pulmonary disorder (chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, suppurative lung disease or diffuse alveolar hemorrhage) or documented barotrauma.
• Presence of cardiac disorder (rheumatic or ischemic heart disease).
• Presence of intracranial hypertension (suspected or confirmed).
• History of malignancies or patients on immunosuppressive drugs.
• Pregnancy or presence of neuromuscular disorder known to prolong intubation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: APRV; The settings for APRV were: High airway pressure (Phigh) set at the last plateau airway pressure (Pplat), not to exceed 30 cmH2O and low airway pressure (Plow) set at (5 cmH2O).; The release phase (Tlow) setting adjusted to terminate the peak expiratory flow rate to ≥ 50%.; Release frequency of 10-14 cycles/min.	Other: mechanical ventilation (MV); Mechanical ventilation APRV mode ( Airway Pressure Release Ventilation ); Other: mechanical ventilation (MV); Mechanical Ventilation in BiPAP mode (Bi-Level Positive Airway Pressure Ventilation )
Other: BiPAP; The settings for BiPAP were: Ti (inspiratory time) is set according to inspiratory time constant.; Optimum PEEP is set according to FiO2 to achieve the goal of SpO2≥90%.; FiO2 is set to achieve the goal of SpO2≥ 90%.	Other: mechanical ventilation (MV); Mechanical ventilation APRV mode ( Airway Pressure Release Ventilation ); Other: mechanical ventilation (MV); Mechanical Ventilation in BiPAP mode (Bi-Level Positive Airway Pressure Ventilation )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
partial pressure of oxgyen in arterial blood	To evaluate whether early use of airway pressure release ventilation (APRV) would improve oxygenation (as assessed by partial pressure of oxygen in the arterial blood (PaO2)).	an average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days on mechanical ventilation	recording number of days patients were on mechanical ventilation in intensive care unit (ICU )	Up to 6 months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Rana A Mohamed, MSc, Ain Shams University

Publications and helpful links

General Publications

• Goligher EC, Hodgson CL, Adhikari NKJ, Meade MO, Wunsch H, Uleryk E, Gajic O, Amato MPB, Ferguson ND, Rubenfeld GD, Fan E. Lung Recruitment Maneuvers for Adult Patients with Acute Respiratory Distress Syndrome. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2017 Oct;14(Supplement_4):S304-S311. doi: 10.1513/AnnalsATS.201704-340OT.
• Cheng J, Ma A, Dong M, Zhou Y, Wang B, Xue Y, Wang P, Yang J, Kang Y. Does airway pressure release ventilation offer new hope for treating acute respiratory distress syndrome? J Intensive Med. 2022 Mar 28;2(4):241-248. doi: 10.1016/j.jointm.2022.02.003. eCollection 2022 Oct.
• Rose L, Hawkins M. Airway pressure release ventilation and biphasic positive airway pressure: a systematic review of definitional criteria. Intensive Care Med. 2008 Oct;34(10):1766-73. doi: 10.1007/s00134-008-1216-3. Epub 2008 Jul 17.
• Fredericks AS, Bunker MP, Gliga LA, Ebeling CG, Ringqvist JR, Heravi H, Manley J, Valladares J, Romito BT. Airway Pressure Release Ventilation: A Review of the Evidence, Theoretical Benefits, and Alternative Titration Strategies. Clin Med Insights Circ Respir Pulm Med. 2020 Feb 5;14:1179548420903297. doi: 10.1177/1179548420903297. eCollection 2020.
• Saddy F, Moraes L, Santos CL, Oliveira GP, Cruz FF, Morales MM, Capelozzi VL, de Abreu MG, Garcia CS, Pelosi P, Rocco PR. Biphasic positive airway pressure minimizes biological impact on lung tissue in mild acute lung injury independent of etiology. Crit Care. 2013 Oct 8;17(5):R228. doi: 10.1186/cc13051.
• Gallagher JJ. Alternative Modes of Mechanical Ventilation. AACN Adv Crit Care. 2018 Winter;29(4):396-404. doi: 10.4037/aacnacc2018372.
• Mireles-Cabodevila E, Dugar S, Chatburn RL. APRV for ARDS: the complexities of a mode and how it affects even the best trials. J Thorac Dis. 2018 Apr;10(Suppl 9):S1058-S1063. doi: 10.21037/jtd.2018.03.156. No abstract available.
• Zhong X, Wu Q, Yang H, Dong W, Wang B, Zhang Z, Liang G. Airway pressure release ventilation versus low tidal volume ventilation for patients with acute respiratory distress syndrome/acute lung injury: a meta-analysis of randomized clinical trials. Ann Transl Med. 2020 Dec;8(24):1641. doi: 10.21037/atm-20-6917.
• Kucuk MP, Ozturk CE, Ilkaya NK, Kucuk AO, Ergul DF, Ulger F. The effect of preemptive airway pressure release ventilation on patients with high risk for acute respiratory distress syndrome: a randomized controlled trial. Braz J Anesthesiol. 2022 Jan-Feb;72(1):29-36. doi: 10.1016/j.bjane.2021.03.022. Epub 2021 Apr 24.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: November 22, 2024
• First Submitted That Met QC Criteria: December 24, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: ARDS; APRV; BiPAP
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: APRV versus Bipap

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To ensure ultimate patients' privacy and disclosure , IPD might not be shared , but data will be available with the corresponding author on special request .

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No