Advantages and Disadvantages of Long Term Sedation in Intensive Care Unit Patients
NCT00466492
Critical Illness, Disease Attributes
Odense C, Denmark
View Trial DetailsNCT Number: NCT07646249
Patients undergoing major non-cardiac surgery may require postoperative mechanical ventilation and transfer from the operating room to the intensive care unit (ICU). This intra-hospital transport phase is critical, as patients may experience changes in respiratory and hemodynamic status, including alterations in oxygenation, ventilation, blood pressure, and heart rate.
During transport, ventilatory support may be provided using different strategies, including manual ventilation with a bag-valve device or mechanical ventilation with a portable ventilator. Although both approaches are commonly used in clinical practice, there is limited evidence comparing their effects on respiratory function, gas exchange, and overall physiological stability during and after transport.
This multicenter, prospective observational study aims to describe current clinical practices in ventilatory support during intra-hospital transport in adult patients undergoing non-cardiac surgery who require ICU admission. The study will also evaluate changes in vital signs, arterial blood gas parameters, and respiratory mechanics, as well as the occurrence of adverse events during transport and postoperative pulmonary complications within the first five days after surgery.
No additional interventions or procedures beyond standard clinical care will be performed. All data will be collected as part of routine clinical practice. The results of this study are expected to improve the understanding of ventilation management during transport and to identify safer and more effective strategies for critically ill postoperative patients.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Intra-hospital transport from the operating room to the intensive care unit (ICU) represents a vulnerable phase for critically ill postoperative patients, particularly for those who remain intubated and require ongoing invasive mechanical ventilation. During this period, patients may develop respiratory and hemodynamic instability, including hypoxemia, ventilation impairment, and adverse cardiovascular events.
In current clinical practice, ventilatory support during transport may be provided either manually, using a bag-valve device, or mechanically, using portable ventilators. Manual ventilation is widely used but may result in variability in tidal volume, airway pressures, respiratory rate, and minute ventilation. In contrast, mechanical ventilation may allow more controlled and protective respiratory support during transport. However, there is limited evidence describing the real-world use of these strategies and their associated physiological effects in patients undergoing non-cardiac surgery.
The VENTICIRT study is a multicenter, prospective observational study designed to describe ventilation practices during intra-hospital transport from the operating room to the ICU in adult patients undergoing non-cardiac surgery under general anesthesia who require postoperative ICU admission for continuation or weaning of invasive mechanical ventilation.
Data will be collected as part of routine clinical care without any modification of standard practice. The study will record patient demographics, surgical and anesthetic characteristics, ventilatory support modality during transport (manual versus mechanical), transport duration, and ventilator settings when applicable. Physiological variables, including vital signs, arterial blood gas values, and respiratory mechanics, will be assessed before and after transport according to routine clinical timing.
Adverse events occurring during transport and postoperative pulmonary complications within five days after surgery will also be documented.
By providing a comprehensive description of current ventilation strategies, their physiological impact, and associated clinical outcomes, this study aims to improve understanding of intra-hospital transport management and to generate evidence that may support safer and more effective care of critically ill postoperative patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Time frame: Periprocedural period
Describe the ventilation strategies applied during transport from the operating room to ICU of the intubated patients subjected to general anesthesia for non-cardiac surgery requiring continuation of IMV in the postoperative period.
Time frame: 30 minutes before- 30 minutes after
assess changes in vital signs (SpO2 in %) in the peritransport period .
Time frame: 30 minutes before- 30 minutes after
assess changes in vital signs (EtCO2 mmHg) in the peritransport period .
Time frame: 30 minutes before- 30 minutes after
assess changes in vital signs (Blood pressure in mmHg), in the peri-transport period
Time frame: 30 minutes before- 30 minutes after
assess changes in vital signs (heart rate in beats per minute) , in the peri-transport period.
Time frame: 30 minutes before - 30 minutes after
assess changes in vital signs ( ECG ST interval modifications) in the peri-transport period.
Time frame: 30 minutes before - 30 minutes after
assess changes in blood gas analysis (pH) in the peri-transport period .
Time frame: 30 minutes before - 30 minutes after
assess changes in blood gas analysis (PaO2 in mmHg) in the peri-transport period .
Time frame: 30 minutes before - 30 minutes after
assess changes in blood gas analysis (lactate concentration) in the peri-transport period .
Time frame: 30 minutes before transport - 30 minutes after transport
assess changes in respiratory mechanics parameters (respiratory system compliance in ml/cmH2O), before and after transport (30 minutes before transport - 30 minutes after transport)
Time frame: 30 minutes before transport - 30 minutes after transport
assess changes in respiratory mechanics parameters (optional calculation of airway resistance cmH2O/(l/s)), before and after transport (30 minutes before transport - 30 minutes after transport)
Time frame: 30 minutes before transport - 30 minutes after transport (whole transport period)
possible application of corrective measures (application or not of protective ventilation defined according to driving pressure in cmH2O and/or tidal volume in ml/kg of predeicted body weigth - descriptive outcome).
Time frame: 30 minutes before transport - 30 minutes after transport (whole transport period)
report the incidence of adverse events such as number of desaturation (descriptive outcome) during transport.
Time frame: 30 minutes before transport - 30 minutes after transport (whole transport period)
Describe the sedation plan and any curarization applied during transport.
Time frame: 30 minutes before transport - 30 minutes after transport (whole transport period)
Report the number of any inotropic/vasopressor medications application (descriptive outcome) 30 minutes before, during, and 30 minutes after transport.
Time frame: within 5 postoperative days
Report the incidence of PPCs within 5 postoperative days.
Time frame: 30 minutes before transport - 30 minutes after transport (whole transport period)
possible application of corrective measures (application and/or modification of positive end-expiratory pressure - descriptive outcome)
Time frame: 30 minutes before transport - 30 minutes after transport (whole transport period)
possible application of corrective measures (application of recruitment maneuvers- descriptive outcome).
Time frame: 30 minutes before transport - 30 minutes after transport (whole transport period)
report the incidence of adverse events such as number of episodes of hemodynamic instability (descritptive outcome) during transport.
Time frame: 30 minutes before transport - 30 minutes after transport (whole transport period)
report the incidence of adverse events such as episodes of cardiocirculatory arrest (descriptive outcome) during transport.
Time frame: 30 minutes before transport - 30 minutes after transport (whole transport period)
report the incidence of adverse events such as arrhythmia events (descriptive outcome), during transport.
Time frame: 30 minutes before transport - 30 minutes after transport (whole transport period)
report the incidence of adverse events such as accidental extubation (descriptive outcome) during transport.
Time frame: 30 minutes before transport - 30 minutes after transport (whole transport period)
Report the number of modifications in inotropic/vasopressor medications (descriptive outcome) 30 minutes before, during, and 30 minutes after transport.
Time frame: 30 minutes before - 30 minutes after
assess changes in blood gas analysis (bicarbonate concentration) in the peri-transport period .
Time frame: 30 minutes before - 30 minutes after
assess changes in blood gas analysis (PaCO2 in mmHg) in the peri-transport period .
Time frame: 30 minutes before - 30 minutes after
assess changes in blood gas analysis (PaO2/FiO2 in mmHg) in the peri-transport period .
Contact information is provided by the study sponsor or research team.
RICERCA SIAARTI Ufficio Ricerca Clinica, Clinical Trial Office
CONTACT
Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
Other
VENtilation Modalities During Transport of PostoperatIve CRITically Ill Patients to the ICU - A Multicenter Observational Study
Acronym: VENTICRIT
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.
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