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.
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
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.
- Conditions
- Acute Hypoxemic Respiratory Failure
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Pressure Support Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
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.
- First posted20 Nov 2025
- Study start26 May 2019
- Primary completion12 Dec 2019
- Study completion28 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Kamal Habib, Ain Shams University
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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07238140
- Acronym / sponsor ID
- FMASU MS 69/2019
- Conditions
- Acute Hypoxemic Respiratory Failure
- Keywords
- weaning, ATC, PSV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 26 May 2019 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 28 Mar 2020 (actual)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparative study between automatic tube compensation and pressure support ventilation as a mode of weaning from mechanical ventilation in patients with respiratory failure
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients were randomly allocated into two parallel groups: ATC group and PSV group
| Arm | Type | Receives |
|---|---|---|
| ATC group | Experimental | Device: Automatic tube compensationATC 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. |
| PSV Group | Active comparator | Device: Pressure Support VentilationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- Age <18 years.
- Pre-existing chronic obstructive pulmonary disease (COPD).
- Neuromuscular disorders.
- Hemodynamic instability requiring high-dose vasoactive support.
- Persistent altered level of consciousness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automatic tube compensationAlso: ATCAutomatic 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. | Device | ATC group |
| Pressure Support VentilationAlso: PSVPressure 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 | Device | PSV Group |
Primary outcome
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
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.
8 secondary outcomes
Change in Respiratory Rate to Tidal Volume Ratio (RR/VT)
Time frame: Immediately before and at the end of the spontaneous breathing trial (SBT), assessed up to 2 hours
Change in Oxygen Saturation (SpO₂)
Time frame: Immediately before and at the end of the spontaneous breathing trial (SBT), assessed up to 2 hours
Change in Dynamic Compliance
Time frame: Immediately before and at the end of the spontaneous breathing trial (SBT), assessed up to 2 hours
Change in Airway Resistance
Time frame: Immediately before and at the end of the spontaneous breathing trial (SBT), assessed up to 2 hours
Change in Intrinsic PEEP
Time frame: Immediately before and at the end of the spontaneous breathing trial (SBT), assessed up to 2 hours
Change in Arterial Oxygen Tension (PaO₂)
Time frame: Immediately before and at the end of the spontaneous breathing trial (SBT), assessed up to 2 hours
Change in Arterial Carbon Dioxide Tension (PaCO₂)
Time frame: Immediately before and at the end of the spontaneous breathing trial (SBT), assessed up to 2 hours
Extubation Success Rate
Time frame: Up to 48 hours post-extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.