Comparative Study Between Airway Pressure Release Ventilation and Pressure Regulated Volume Control (PRVC) in Protective Lung Strategy as a Recruitment Maneuver for Severe ARDS Mechanically Ventilated Patients Using Lung Ultrasound Score

NCT07231107 | Completed DMC

• 1 other identifier: FMASU MD 190/2022
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to elaborate on the effectiveness of recruitment maneuver by airway pressure release ventilation (APRV) as an open lung ventilatory strategy in comparison with PRVC mode in lung protective strategy regarding improvement of LUS score and P/F ratio in patients with severe ARDS

Conditions

ARDS (Acute Respiratory Distress Syndrome)

Keywords

Lung ultrasound; APRV; recruitment

Outcome Measures

Primary Outcomes (2)

• lung ultrasound score

  assessment of the lung interstitial tissue by ultrasound Ultrasound patterns at different degrees of lung aeration. 1. Normal lung ultrasound pattern (score = 0). 2. Well-Spaced B lines (moderate loss of aeration; score = 1). 3. Coalescent B lines (severe loss of aeration; score = 2). 4. Consolidated lung (complete loss of aeration; score = 3).

  7 days started after mechanical ventilation

• P/F Ratio (Pao2/Fio2 Ratio)

  ratio between the Partial pressure of Oxygen and the fraction of inspired oxygen Mild ARDS: 200 mmHg \<Pao2/Fio2 \< 300 mmHg Moderate ARDS:100 mmHg \<Pao2/Fio2 \< 200 mmHg Severe ARDS: Pao2/Fio2 \< 100 mmHg

  7 days started after mechanical ventilation

Secondary Outcomes (8)

• Heart rate. (BPM).

  every 24 hours for 7 days after mechanical ventilation

• Invasive Mean arterial blood pressure. (mmHG).

  every 24 hours for 7 days after mechanical ventilation

• Vasopressor-Inotrope score (VIS)

  every 24 hours for 7 days after mechanical ventilation

• Lung compliance. (mL/cmH2O).

  every 24 hours for 7 days after mechanical ventilation

• Oxygenation index

  every 24 hours for 7 days after mechanical ventilation

Other Outcomes (5)

• SOFA score

  Every 24 hours for 7 day

• LIS score

  Every 24 hours for 7 day

• Mean airway pressure (Paw)

  Every 24 hours for 7 day

Study Arms (2)

PRVC ventilated ARDS patients

ACTIVE COMPARATOR

managed by using conventional lung protective strategy using Pressure regulated volume control mode (PRVC) and positive end expiratory pressure, initial setting Tidal volume (VT):4-6ml/kg predicted body weight, PEEP according to ARDSnet guidelines recommendation for Low tidal volume high strategy.

Procedure: Lung ultrasound

APRV ventilated ARDS patients

ACTIVE COMPARATOR

managed by airway pressure release ventilation mode initial settings Phigh:25 Plow:0 Thigh: 4.5 Tlow: 0.5 Fio2: 1. Options for setting the Phigh either premeasured Pplat or according to the Oxygenation index.

Procedure: Lung ultrasound

Interventions

Lung ultrasound PROCEDURE

bedside lung ultrasound in six lung regions of interest, delineated by a parasternal line, anterior axillary line, posterior axillary line, and paravertebral line, are examined on each side. Each lung region is carefully examined in the longitudinal plane, and each intercostal space present in the region is examined in the transversal plane. The worst ultrasound pattern characterizes the region (regional LUS) using the following grading: 0 = normal aeration; 1 = moderate loss of aeration (interstitial syndrome, defined by multiple spaced B lines, or localized pulmonary edema, defined by coalescent B lines in less than 50% of the intercostal space examined in the transversal plane, or subpleural consolidations); 2 = severe loss of aeration (alveolar edema, defined by diffused coalescent B lines occupying the whole intercostal space); and 3 = complete loss of lung aeration (lung consolidation defined as a tissue pattern with or without air bronchogram)

APRV ventilated ARDS patients; PRVC ventilated ARDS patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18-60 years old.
• Sex: both males and females
• Accepts health volunteers: No
• all Patients who were mechanically ventilated and diagnosed to have ARDS due to sepsis according to Berlin definition.
• Berlin Definition of the acute respiratory distress syndrome (ARDS) Acute Respiratory Distress Syndrome Timing Within 1 week of a known clinical insult or new or worsening respiratory Symptoms Chest imaging Bilateral opacities - not fully explained by effusion, lobar/lung collapse, or nodules. Origin of edema Respiratory failure not fully explained by cardiac failure or fluid overload need objective assessment (eg, echocardiography) to exclude hydrostatic edema if no risk factor present.
• Oxygenation Mild 200 mmHg \<Pao2/Fio2 \< 300 mmHg with PEEP or CPAP \> 5 cmH2O. Moderate 100 mmHg \<Pao2/Fio2 \< 200 mmHg with PEEP \> 5 cmH2O. Severe Pao2/Fio2 \< 100 mmHg with PEEP \> 5 cmH2O. (Gordon D, et al; 2012). Diagnostic Criteria for the New Global Definition of ARDS Acute Respiratory Distress Syndrome Risk factors and origin of edema Precipitated by an acute predisposing risk factor, such as pneumonia, non-pulmonary infection, trauma, transfusion, aspiration, or shock.
• Pulmonary edema is not exclusively or primarily attributable to cardiogenic pulmonary edema/fluid overload, and hypoxemia/gas exchange abnormalities are not primarily attributable to atelectasis. However, ARDS can be diagnosed in the presence of these conditions if a predisposing risk factor for ARDS is also present.
• Timing Acute onset or worsening of hypoxemic respiratory failure within 1 week of the estimated onset of the predisposing risk factor or new or worsening respiratory symptoms.
• Chest imaging Bilateral opacities on chest radiography and computed tomography or bilateral B lines and/or consolidations on ultrasound\* not fully explained by effusions, atelectasis, or nodules / masses.
• Oxygenation Non-intubated ARDS Intubated ARDS Modified Definition for Resource-Limited Settings
• PaO2:FIO2\<300mmHg or
• SpO2:FIO2\<315 (if SpO2\<97%) on HFNO with flow of \>30 L/min or NIV/CPAP with at least 5 cm H2O end-expiratory pressure Mild:
• \<PaO2:FIO2\<300 mm Hg Or
• \<SpO2:FIO2\<315 (if SpO2\<97%)
• Moderate:

You may not qualify if:

• Patient refusal
• Patient with advanced cardiac disorders (rheumatic or ischemic).
• Patients with COPD, pneumothorax, surgical emphysema.
• Patients with advanced liver or renal disorders
• Patients with advanced malignancy.
• Female patients during pregnancy.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ainshams University

Cairo, Abbasia, 00202, Egypt

Location

Related Publications (5)

• ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.

  PMID: 22797452 RESULT

• Matthay MA, Arabi Y, Arroliga AC, Bernard G, Bersten AD, Brochard LJ, Calfee CS, Combes A, Daniel BM, Ferguson ND, Gong MN, Gotts JE, Herridge MS, Laffey JG, Liu KD, Machado FR, Martin TR, McAuley DF, Mercat A, Moss M, Mularski RA, Pesenti A, Qiu H, Ramakrishnan N, Ranieri VM, Riviello ED, Rubin E, Slutsky AS, Thompson BT, Twagirumugabe T, Ware LB, Wick KD. A New Global Definition of Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2024 Jan 1;209(1):37-47. doi: 10.1164/rccm.202303-0558WS.

  PMID: 37487152 RESULT

• Habashi NM. Other approaches to open-lung ventilation: airway pressure release ventilation. Crit Care Med. 2005 Mar;33(3 Suppl):S228-40. doi: 10.1097/01.ccm.0000155920.11893.37.

  PMID: 15753733 RESULT

• 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.

  PMID: 33905798 RESULT

• Borges JB, Okamoto VN, Matos GF, Caramez MP, Arantes PR, Barros F, Souza CE, Victorino JA, Kacmarek RM, Barbas CS, Carvalho CR, Amato MB. Reversibility of lung collapse and hypoxemia in early acute respiratory distress syndrome. Am J Respir Crit Care Med. 2006 Aug 1;174(3):268-78. doi: 10.1164/rccm.200506-976OC. Epub 2006 May 11.

  PMID: 16690982 RESULT

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: post graduate student

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: November 17, 2025
• Study Start: August 18, 2022
• Primary Completion: August 1, 2023
• Study Completion: July 1, 2024
• Last Updated: December 3, 2025

Record last verified: 2025-12

Locations

EG (1)