intensive care unit Department, Ain Shams University Hospital
Cairo, Cairo Governorate, 11835, Egypt
NCT Number: NCT07238140
Comparative study between automatic tube compensation and pressure support ventilation as a mode of weaning from mechanical ventilation in patients with respiratory failure
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Cairo, Cairo Governorate, 11835, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: ATC
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
Other names: PSV
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.
Time frame: Immediately before and at the end of the spontaneous breathing trial (SBT), assessed up to 2 hours
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.
Time frame: Immediately before and at the end of the spontaneous breathing trial (SBT), assessed up to 2 hours
Evaluation of oxygen saturation changes during the spontaneous breathing trial to assess the patient's oxygenation status.
Time frame: Immediately before and at the end of the spontaneous breathing trial (SBT), assessed up to 2 hours
Measurement of dynamic respiratory system compliance to assess lung mechanics before and after the spontaneous breathing trial.
Time frame: Immediately before and at the end of the spontaneous breathing trial (SBT), assessed up to 2 hours
Assessment of changes in airway resistance during weaning to evaluate respiratory mechanics at baseline and after the SBT
Time frame: Immediately before and at the end of the spontaneous breathing trial (SBT), assessed up to 2 hours
Measurement of intrinsic PEEP values before and after the spontaneous breathing trial to assess changes in auto-PEEP during weaning.
Time frame: Immediately before and at the end of the spontaneous breathing trial (SBT), assessed up to 2 hours
Assessment of PaO₂ changes during weaning to evaluate oxygenation efficiency before and after the spontaneous breathing trial.
Time frame: Immediately before and at the end of the spontaneous breathing trial (SBT), assessed up to 2 hours
Assessment of PaCO₂ changes during weaning to evaluate ventilation efficiency before and after the spontaneous breathing trial.
Time frame: Up to 48 hours post-extubation
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.
Ain Shams University
Other
Comparative Study Between Automatic Tube Compensation and Pressure Support Ventilation as a Mode of Weaning From Mechanical Ventilation in Patients With Respiratory Failure
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06333002
Acute Hypoxemic Respiratory Failure, Respiration Disorders
Ciudad Real, Spain
View Trial DetailsNCT06815523
Acute Hypoxemic Respiratory Failure, Respiration Disorders
Las Palmas de Gran Canaria, Las Palmas, Spain
View Trial DetailsNCT06204276
Acute Hypercapnic Respiratory Failure, Acute Hypoxemic Respiratory Failure
Bangkok Noi, Bangkok, Thailand
View Trial DetailsNCT05759832
Acute Hypoxemic Respiratory Failure, High-flow Nasal Cannula Oxygen
Beijing, Beijing Municipality, China
View Trial Details