Compare Between APRV and Bipap Ventilation in ARDS Patients

NCT06755320 | Not Yet Recruiting DMC

• 1 other identifier: APRV versus Bipap
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

ARDS: Acute Respiratory Distress Syndrome; ARDS

Keywords

ARDS; APRV; BiPAP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of days on mechanical ventilation

  Up to 6 months

Study Arms (2)

APRV

OTHER

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)

BiPAP

OTHER

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)

Interventions

mechanical ventilation (MV) OTHER

Mechanical ventilation APRV mode ( Airway Pressure Release Ventilation )

APRV

Eligibility Criteria

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

You may qualify if:

• Patients who meet all ARDS criteria (according to Berlin definition).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (9)

• 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.

  PMID: 32076372 BACKGROUND

• 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.

  PMID: 24103805 BACKGROUND

• 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.

  PMID: 29043837 BACKGROUND

• Gallagher JJ. Alternative Modes of Mechanical Ventilation. AACN Adv Crit Care. 2018 Winter;29(4):396-404. doi: 10.4037/aacnacc2018372.

  PMID: 30523010 BACKGROUND

• 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.

  PMID: 29850185 BACKGROUND

• 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.

  PMID: 36785647 BACKGROUND

• 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.

  PMID: 33490153 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 18633595 BACKGROUND

MeSH Terms

Conditions

Acute Lung Injury

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Officials

• Rana A Mohamed, MSc

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rana A Mohamed, MSc

CONTACT

+20 1020511666; d.rana386@yahoo.com

Ahmed F Abdelraouf, PhD

CONTACT

+20 1024174200; awinnersid30@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Prospective Randomized Clinical Trial.

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: January 1, 2025
• Study Start: December 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: August 1, 2025
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share