The Impact of PEEP-guided Electrical Impedance Tomography on Oxygenation and Pulmonary Mechanics in Moderate-to-severe ARDS

NCT06733168 | Recruiting

• 1 other identifier: TrungHSTC 5532/BM-HDDD
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Acute respiratory distress syndrome (ARDS) in its moderate to severe forms is associated with high mortality. Mechanical ventilation (MV) remains the cornerstone of ARDS management but carries a significant risk of ventilator-induced lung injury (VILI). Positive end-expiratory pressure (PEEP), a fundamental component of MV, is widely utilized in clinical practice; however, optimal PEEP selection for patients with moderate to severe ARDS remains a complex and unresolved challenge. Electrical impedance tomography (EIT), a bedside imaging modality that evaluates regional ventilation distribution, offers a means of individualizing PEEP settings in mechanically ventilated patients. By balancing the competing risks of alveolar overdistension and collapse, EIT facilitates precision in PEEP titration. This study compares the impact of EIT-guided PEEP selection versus the conventional low FiO2-PEEP table on blood oxygenation and pulmonary mechanics.

Conditions

Acute Respiratory Syndrome Distress; Positive End-Expiratory Pressure; Mechanical Ventilation; Electrical Impedance Tomography (EIT)

Keywords

Acute respiratory syndrome distress; Mechanical Ventilation; Positive End-Expiratory Pressure; electrical impedance tomography; blood oxygenation; pulmonary mechanics

Outcome Measures

Primary Outcomes (2)

• Oxygenation

  PaO2/FiO2 will be evaluated via arterial blood gas analysis every day during the first week treatment.

  at day 1, 2, 3, 4, 5, 6, 7

• Pulmonary Mechanic

  Static Compliance

  at day 1, 2, 3, 4, 5, 6, 7

Secondary Outcomes (7)

• Ventilator free days

  up to 28 days

• Length of ICU stay

  up to 28 days

• Length of mechanical ventilated days

  up to 28 days

• Pneumothorax or barotrauma

  up to 28 days

• Rescue therapies

  up to 7 days

Study Arms (2)

EIT-PEEP setting

ACTIVE COMPARATOR

Patients will have PEEP settings determined by EIT guidance following a stepwise decremental PEEP trial

Device: electrical impedance tomography

ARDSNet-PEEP setting

PLACEBO COMPARATOR

PEEP will be adjusted using the low FiO2-PEEP table to achieve oxygenation targets: SpO2 between 88% and 95% and PaO2 between 55 mmHg and 80 mmHg

Other: Non-EIT

Interventions

electrical impedance tomography DEVICE

Before initiating recruitment maneuver, all patients were placed on mechanical ventilation set according to the ARDSnetwork strategy for 10 minutes, ensuring SpO2 of 88-95%, PaO2 of 55-80 mmHg, and a mean arterial pressure (MAP) ≥ 65 mmHg. * PEEP was incrementally increased by 5 cmH2O every minute: from 10 to 15, to 20, and finally to 25 cmH2O, with a maximum pressure limit of 40 cmH2O. * Following recruitment maneuver at the final PEEP level, the process of identifying the optimal PEEP was initiated. * Then, PEEP will be set to 20 cmH2O and was gradually decreased by 2 cmH2O every 30 seconds until it reached 6 cmH2O or SpO2 dropped to ≤ 80%. * Selection of optimal PEEP: The optimal PEEP was defined as the intersection point between the alveolar overdistension and collapse curves as measured by the EIT system.

EIT-PEEP setting

Non-EIT OTHER

Patients will have PEEP set using the low FiO2-PEEP table, based on the ARDSnet protocol

ARDSNet-PEEP setting

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years.
• Intubated moderate and severe ARDS according to the New Global Definition (PaO2/FiO2 ≤200 mmHg).
• Used continuous sedation with or without paralysis.

You may not qualify if:

• Presence of pneumothorax that is either undrained or newly occurred.
• Unstable hemodynamics with a mean arterial pressure \< 60 mmHg and unresponsive to resuscitation measures, and/or heart rate \< 60 bpm.
• Contraindications for EIT (pacemakers, automatic external defibrillators, cases of chest trauma or recent chest surgery limiting EIT belt application).
• Pregnancy.
• Severe neuromuscular disease.

Sponsors & Collaborators

• Vietnam Military Medical University: lead
• Hanoi Medical University: collaborator
• Bach Mai Hospital: collaborator

Study Sites (1)

Intensive Care Center, Bach Mai Hospital

Hanoi, Vietnam

RECRUITING

Related Publications (4)

• Costa EL, Borges JB, Melo A, Suarez-Sipmann F, Toufen C Jr, Bohm SH, Amato MB. Bedside estimation of recruitable alveolar collapse and hyperdistension by electrical impedance tomography. Intensive Care Med. 2009 Jun;35(6):1132-7. doi: 10.1007/s00134-009-1447-y. Epub 2009 Mar 3.

  PMID: 19255741 RESULT

• Jimenez JV, Weirauch AJ, Culter CA, Choi PJ, Hyzy RC. Electrical Impedance Tomography in Acute Respiratory Distress Syndrome Management. Crit Care Med. 2022 Aug 1;50(8):1210-1223. doi: 10.1097/CCM.0000000000005582. Epub 2022 May 23.

  PMID: 35607967 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

• Van Trung D, Giang BTH, Tuan DQ, Tan NC, Thach PT, Van Cuong B, Cuong NB, Anh TT, Anh NT, Van Huy N, Trieu HD, Van Trong N, Trang TT, Toan VX, Nam NH, Sam NT, Thanh TM, Dat NT, Hong NTP, Phuong PTH, Hien DD, Van Hoi D, Phong HT, Thu ND, Trang NT, Hieu NX, Dat HT, Phuong DX, Son DN. The impact of PEEP-guided electrical impedance tomography on oxygenation and respiratory mechanics in moderate-to-severe ARDS: a randomized controlled trial. Sci Rep. 2025 Nov 29;16(1):391. doi: 10.1038/s41598-025-29787-5.

  PMID: 41318662 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Trung Van Dinh, MD

CONTACT

(+84) 988519190; dinhvantrung.ptgh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD

Model Details: Prospective, single center, ramdomized controlled trial

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 13, 2024
• Study Start: August 15, 2024
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)