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Acute Hypoxemic Respiratory FailureNCT07238140

ATC vs PSV for Weaning in Patients With Respiratory Failure

A study testing Automatic tube compensation and Pressure Support Ventilation in people with Acute Hypoxemic Respiratory Failure, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Hypoxemic Respiratory Failure
What is being tested?
Automatic tube compensation and Pressure Support Ventilation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
26 May 2019to 28 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • Severe metabolic or electrolyte disturbances.
  • Morbid obesity (BMI ≥40 kg/m²).
  • Tracheostomy.
  • Pregnancy.
  • Refusal to participate by patient or legal guardian.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • intensive care unit Department, Ain Shams University Hospital

    Cairo, Cairo Governorate, 11835

Other trials in Egypt

About this study

Official title: Comparative Study Between Automatic Tube Compensation and Pressure Support Ventilation as a Mode of Weaning From Mechanical Ventilation in Patients With Respiratory Failure

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

Read the detailed description

Mechanical ventilation is a cornerstone in the management of patients with acute respiratory failure, but prolonged dependence on the ventilator is associated with increased morbidity, mortality, and healthcare costs. Weaning, the process of transitioning a patient from mechanical ventilation to spontaneous breathing, is a critical phase that requires careful timing and appropriate methodology. The spontaneous breathing trial (SBT) is a widely used tool to assess weaning readiness, and several ventilatory modes have been developed to optimize this step. Among these, Automatic Tube Compensation (ATC) and Pressure Support Ventilation (PSV) are two commonly applied modes, each with distinct physiological principles.

ATC is designed to compensate precisely for the resistance imposed by the endotracheal tube, aiming to reproduce the normal work of breathing as if the patient were breathing without the artificial airway. In contrast, PSV provides a fixed level of pressure support throughout inspiration, which assists respiratory muscles and reduces the work of breathing but may not adapt dynamically to changes in flow or resistance. Although both modes are frequently used in intensive care units, evidence comparing their effectiveness in facilitating weaning and extubation success has been variable, with some studies suggesting physiological advantages of ATC but limited data on clinical outcomes.

his prospective randomized clinical trial was conducted to address this gap by directly comparing ATC and PSV as SBT modes in adult patients with acute respiratory failure receiving invasive mechanical ventilation. Patients were screened for weaning readiness using standardized clinical and physiological criteria and were subsequently randomized to undergo SBT with either ATC or PSV. Interventions were delivered following established ICU protocols to ensure safety and uniformity across groups.

Throughout the study, key respiratory and gas exchange parameters were monitored before and after the SBT to assess physiological responses to the two modes. Extubation decisions were based on predefined criteria to minimize variability in clinical judgment. Patients were followed for early post-extubation outcomes to evaluate the clinical impact of each mode on weaning success. The primary endpoint focused on improvement in oxygenation, while secondary endpoints included respiratory mechanics and post-extubation outcomes. The study adhered to ethical regulations, with written informed consent obtained prior to enrollment. By providing a structured comparison of these two modes, the study contributes to the evidence guiding optimal weaning strategies in adult critically ill patients, potentially improving clinical outcomes and optimizing ICU resource utilization.

Statistical analysis was performed using SPSS software (version 16.0; IBM Corp., Armonk, NY, USA). The required sample size was calculated a priori to provide 80% power to detect a clinically meaningful difference in the primary outcome at a two-sided significance level of 0.05. Continuous variables were expressed as mean ± standard deviation and compared between groups using appropriate parametric tests. Categorical variables were presented as frequencies and percentages, and analyzed using the Chi-square test or Fisher's exact test as indicated. A P value < 0.05 was considered statistically significant. Diagnostic accuracy was assessed using receiver operating characteristic (ROC) curve analysis, with calculation of sensitivity, specificity, positive predictive value, and negative predictive value.

The results of this completed study provide valuable clinical evidence regarding the optimal mode of spontaneous breathing trials in adult patients with acute respiratory failure. By comparing ATC and PSV, the study highlights differences in physiological responses and clinical outcomes between the two modes. These findings can help refine weaning protocols, support clinical decision-making, and contribute to improving extubation success rates and patient outcomes in intensive care settings. Moreover, the results may serve as a reference for future research and guideline development, particularly in resource-limited environments.

Being tested
Automatic tube compensation, Pressure Support Ventilation
Keywords
weaning, ATC, PSV
Medical subject headings
Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Automatic tube compensationDevice

    Also called ATC

    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.

  • Pressure Support VentilationDevice

    Also called PSV

    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

Study groups in NCT07238140
Study groupRoleWhat they receive
ATC groupExperimentalATC 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.
Receives: Device: Automatic tube compensation
PSV GroupActive comparatorPatients 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.
Receives: Device: Pressure Support Ventilation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (8)
  1. Change in Respiratory Rate to Tidal Volume Ratio (RR/VT)

    Assessment of the rapid shallow breathing index (RR/VT) as a predictor of weaning success. Measurements will be taken at baseline and at the end of the spontaneous breathing trial to assess changes during weaning.

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

  2. Change in Oxygen Saturation (SpO₂)

    Evaluation of oxygen saturation changes during the spontaneous breathing trial to assess the patient's oxygenation status.

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

  3. Change in Dynamic Compliance

    Measurement of dynamic respiratory system compliance to assess lung mechanics before and after the spontaneous breathing trial.

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

  4. Change in Airway Resistance

    Assessment of changes in airway resistance during weaning to evaluate respiratory mechanics at baseline and after the SBT

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

  5. Change in Intrinsic PEEP

    Measurement of intrinsic PEEP values before and after the spontaneous breathing trial to assess changes in auto-PEEP during weaning.

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

  6. Change in Arterial Oxygen Tension (PaO₂)

    Assessment of PaO₂ changes during weaning to evaluate oxygenation efficiency before and after the spontaneous breathing trial.

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

  7. Change in Arterial Carbon Dioxide Tension (PaCO₂)

    Assessment of PaCO₂ changes during weaning to evaluate ventilation efficiency before and after the spontaneous breathing trial.

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

  8. Extubation Success Rate

    Proportion of patients who maintain spontaneous breathing without signs of respiratory distress or hemodynamic instability for 48 hours after extubation. This outcome assesses the overall success of weaning.

    Measured: Up to 48 hours post-extubation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2025
  2. Study start26 May 2019
  3. Primary completion12 Dec 2019
  4. Study completion28 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients were randomly allocated into two parallel groups: ATC group and PSV group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07238140
Sponsor's protocol ID
FMASU MS 69/2019
Status last verified
Oct 2025
First submitted
1 Oct 2025
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) from this study, including clinical parameters, ventilatory settings, oxygenation indices, and demographic information, will be shared with qualified researchers upon request after publication of the study results. Requests will be reviewed by the Principal Investigator, and approved data will be shared via a secure repository. No personal identifiers will be included to ensure participant confidentiality.

Questions about this trial

What is this clinical trial studying?

A study testing Automatic tube compensation and Pressure Support Ventilation in people with Acute Hypoxemic Respiratory Failure, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in PaO₂/FiO₂ ratio (oxygenation index) during spontaneous breathing trial (time frame: Immediately before and at the end of the spontaneous breathing trial (SBT), assessed up to 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.

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