ATC vs PSV for Weaning in Patients With Respiratory Failure

NCT07238140 | Completed

• 1 other identifier: FMASU MS 69/2019
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Comparative study between automatic tube compensation and pressure support ventilation as a mode of weaning from mechanical ventilation in patients with respiratory failure

Conditions

Acute Hypoxemic Respiratory Failure

Keywords

weaning; ATC; PSV

Outcome Measures

Primary Outcomes (1)

• Change in PaO₂/FiO₂ ratio (oxygenation index) during spontaneous breathing trial

  The primary outcome was the change in the PaO₂/FiO₂ ratio measured immediately before and at the end of the spontaneous breathing trial (SBT). This parameter reflects the efficiency of oxygen exchange and is a validated predictor of weaning success. Higher improvements in the PaO₂/FiO₂ ratio indicate better respiratory function and a higher likelihood of successful extubation.

  Immediately before and at the end of the spontaneous breathing trial (SBT), assessed up to 2 hours

Secondary Outcomes (8)

• Change in Respiratory Rate to Tidal Volume Ratio (RR/VT)

  Immediately before and at the end of the spontaneous breathing trial (SBT), assessed up to 2 hours

• Change in Oxygen Saturation (SpO₂)

  Immediately before and at the end of the spontaneous breathing trial (SBT), assessed up to 2 hours

• Change in Dynamic Compliance

  Immediately before and at the end of the spontaneous breathing trial (SBT), assessed up to 2 hours

• Change in Airway Resistance

  Immediately before and at the end of the spontaneous breathing trial (SBT), assessed up to 2 hours

• Change in Intrinsic PEEP

  Immediately before and at the end of the spontaneous breathing trial (SBT), assessed up to 2 hours

Study Arms (2)

ATC group

EXPERIMENTAL

ATC mode was applied at 100% compensation during the spontaneous breathing trial using a Puritan-Bennett 840 ventilator. Patients breathed through the ventilator circuit with flow triggering (1 L/min), PEEP of 5 cmH₂O, and FiO₂ \< 0.5. This intervention aimed to assist patients during weaning from mechanical ventilation.

Device: Automatic tube compensation

PSV Group

ACTIVE COMPARATOR

Patients were weaned using Pressure Support Ventilation (PSV). They breathed through the ventilator circuit with flow triggering (1 L/min), PEEP of 5 cmH₂O, FiO₂ \< 0.5, and pressure support adjusted to achieve a tidal volume of 6-8 mL/kg predicted body weight.

Device: Pressure Support Ventilation

Interventions

Automatic tube compensation DEVICE

Automatic Tube Compensation (ATC) mode was applied at 100% using a Puritan-Bennett 840 ventilator during spontaneous breathing trials. This mode compensates for the additional resistance imposed by the endotracheal tube, thereby reducing patients' work of breathing and facilitating weaning from mechanical ventilation. Flow triggering was set at 1 L/min, with PEEP of 5 cmH₂O and FiO₂ \< 0.5.

Also known as: ATC

ATC group

Pressure Support Ventilation DEVICE

Pressure Support Ventilation (PSV) was applied during spontaneous breathing trials using a Puritan-Bennett 840 ventilator. Patients breathed through the ventilator circuit with flow triggering set at 1 L/min, positive end-expiratory pressure (PEEP) of 5 cmH₂O, and fraction of inspired oxygen (FiO₂) \< 0.5. Pressure support levels were adjusted to achieve a tidal volume of 6-8 mL/kg of predicted body weight

Also known as: PSV

PSV Group

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.
• Admitted with acute respiratory failure (ARF).
• On mechanical ventilation with Puritan-Bennett 840 ventilator for ≥24 hours.
• Considered for weaning after improvement or resolution of underlying cause.
• Fully conscious.
• Minimal or no requirement for vasoactive drugs or sedation.
• Adequate gas exchange (PaO₂/FiO₂ \>200 at PEEP 5 cmH₂O and FiO₂ \<0.5) Rapid shallow breathing index (RSBI) \<105 breaths/min/L.

You may not qualify if:

• Age \<18 years.
• Pre-existing chronic obstructive pulmonary disease (COPD).
• Neuromuscular disorders.
• Hemodynamic instability requiring high-dose vasoactive support.
• Persistent altered level of consciousness.
• Ongoing sedation.
• Severe metabolic or electrolyte disturbances.
• Morbid obesity (BMI ≥40 kg/m²).
• Tracheostomy.
• Pregnancy.
• Refusal to participate by patient or legal guardian.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

intensive care unit Department, Ain Shams University Hospital

Cairo, Cairo Governorate, 11835, Egypt

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

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: Lecturer of Anesthesia and Intensive Care

Model Details: Patients were randomly allocated into two parallel groups: ATC group and PSV group

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: November 20, 2025
• Study Start: May 26, 2019
• Primary Completion: December 12, 2019
• Study Completion: March 28, 2020
• Last Updated: November 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: * Start Date: Upon publication of the study results. * End Date: 5 years after publication.
• Access Criteria: Qualified researchers may request access to de-identified individual participant data (IPD) from this study, including clinical parameters, ventilatory settings, oxygenation indices, and demographic information. Supporting information such as Study Protocol, Statistical Analysis Plan (SAP), and Clinical Study Report (CSR) will also be provided. Requests will be submitted to the Principal Investigator for review. Approved requests will receive the data through a secure repository to ensure confidentiality. Data will not include any personal identifiers, and access is limited to research purposes only.

Locations

EG (1)