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VENtilation Modalities During Transport of PostoperatIve CRITically Ill Patients to the ICU (VENTICRIT)

VENtilation Modalities During Transport of PostoperatIve CRITically Ill Patients to the ICU - A Multicenter Observational Study

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.

調査の概要

詳細な説明

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.

研究の種類

観察的

入学 (推定)

800

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:RICERCA SIAARTI Ufficio Ricerca Clinica, Clinical Trial Office
  • 電話番号:0039 06 4452816
  • メールricerca@siaarti.it

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

Intubated adult patients (≥18 years) undergoing general anesthesia (intravenous or mixed) for non-cardiac surgery, requiring transport from the operating room to the ICU for continuation/weaning from IMV in the postoperative period.

説明

Inclusion criteria

  • Intubated patients undergoing general anesthesia for non-cardiac surgery
  • Requirement for postoperative IMV
  • Age ≥18 years
  • Obtained informed consent Exclusion criteria
  • Patients undergoing cardiac surgery
  • Patients receiving preoperative mechanical ventilation prior to surgery.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Ventilation strategies applied during transport
時間枠: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.
Periprocedural period

二次結果の測定

結果測定
メジャーの説明
時間枠
assess changes in vital signs and blood gas analysis in the peri-transport period
時間枠:30 minutes before- 30 minutes after
assess changes in vital signs (SpO2 in %) in the peritransport period .
30 minutes before- 30 minutes after
assess changes in vital signs and blood gas analysis in the peri-transport period
時間枠:30 minutes before- 30 minutes after
assess changes in vital signs (EtCO2 mmHg) in the peritransport period .
30 minutes before- 30 minutes after
assess changes in vital signs and blood gas analysis in the peri-transport period
時間枠:30 minutes before- 30 minutes after
assess changes in vital signs (Blood pressure in mmHg), in the peri-transport period
30 minutes before- 30 minutes after
assess changes in vital signs and blood gas analysis in the peri-transport period
時間枠:30 minutes before- 30 minutes after
assess changes in vital signs (heart rate in beats per minute) , in the peri-transport period.
30 minutes before- 30 minutes after
assess changes in vital signs and blood gas analysis in the peri-transport period
時間枠:30 minutes before - 30 minutes after
assess changes in vital signs ( ECG ST interval modifications) in the peri-transport period.
30 minutes before - 30 minutes after
assess changes in vital signs and blood gas analysis in the peri-transport period
時間枠:30 minutes before - 30 minutes after
assess changes in blood gas analysis (pH) in the peri-transport period .
30 minutes before - 30 minutes after
assess changes in vital signs and blood gas analysis in the peri-transport period
時間枠:30 minutes before - 30 minutes after
assess changes in blood gas analysis (PaO2 in mmHg) in the peri-transport period .
30 minutes before - 30 minutes after
assess changes in vital signs and blood gas analysis in the peri-transport period
時間枠:30 minutes before - 30 minutes after
assess changes in blood gas analysis (lactate concentration) in the peri-transport period .
30 minutes before - 30 minutes after
assess changes in respiratory mechanics parameters before and after transport
時間枠: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)
30 minutes before transport - 30 minutes after transport
assess changes in respiratory mechanics parameters before and after transport
時間枠: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)
30 minutes before transport - 30 minutes after transport
assess modification of mechanical ventilation setup
時間枠: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).
30 minutes before transport - 30 minutes after transport (whole transport period)
incidence of adverse events
時間枠: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.
30 minutes before transport - 30 minutes after transport (whole transport period)
sedation plan and any curarization applied
時間枠:30 minutes before transport - 30 minutes after transport (whole transport period)
Describe the sedation plan and any curarization applied during transport.
30 minutes before transport - 30 minutes after transport (whole transport period)
Inotropic/vasopressor medications applied and/or modified
時間枠: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.
30 minutes before transport - 30 minutes after transport (whole transport period)
Incidence of PPCs
時間枠:within 5 postoperative days
Report the incidence of PPCs within 5 postoperative days.
within 5 postoperative days
assess modification of mechanical ventilation setup
時間枠: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)
30 minutes before transport - 30 minutes after transport (whole transport period)
assess modification of mechanical ventilation setup
時間枠:30 minutes before transport - 30 minutes after transport (whole transport period)
possible application of corrective measures (application of recruitment maneuvers- descriptive outcome).
30 minutes before transport - 30 minutes after transport (whole transport period)
incidence of adverse events
時間枠: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.
30 minutes before transport - 30 minutes after transport (whole transport period)
incidence of adverse events
時間枠: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.
30 minutes before transport - 30 minutes after transport (whole transport period)
incidence of adverse events
時間枠: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.
30 minutes before transport - 30 minutes after transport (whole transport period)
incidence of adverse events
時間枠: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.
30 minutes before transport - 30 minutes after transport (whole transport period)
Inotropic/vasopressor medications applied and/or modified
時間枠: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.
30 minutes before transport - 30 minutes after transport (whole transport period)
assess changes in vital signs and blood gas analysis in the peri-transport period
時間枠:30 minutes before - 30 minutes after
assess changes in blood gas analysis (bicarbonate concentration) in the peri-transport period .
30 minutes before - 30 minutes after
assess changes in vital signs and blood gas analysis in the peri-transport period
時間枠:30 minutes before - 30 minutes after
assess changes in blood gas analysis (PaCO2 in mmHg) in the peri-transport period .
30 minutes before - 30 minutes after
assess changes in vital signs and blood gas analysis in the peri-transport period
時間枠:30 minutes before - 30 minutes after
assess changes in blood gas analysis (PaO2/FiO2 in mmHg) in the peri-transport period .
30 minutes before - 30 minutes after

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

  • Morita Y. et al. Comparison of Manual and Mechanical Ventilation During Intensive Care Unit Transport Following Cardiac Surgery: Impact on Oxygenation, Ventilation, and Hemodynamic Stability. J Cardiothorac Vasc Anesth. 2025 Mar;39(3):644-652.LAS VEGAS investigators, Epidemiology, practice of ventilation and outcome for patients at increased risk of postoperative pulmonary complications: LAS VEGAS - an observational study in 29 countries. Eur J Anaesthesiol. 2017 Aug;34(8):492-507 Matthay et al. A New Global Definition of Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2024 Jan 1;209(1):37-47

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月1日

一次修了 (推定)

2027年10月1日

研究の完了 (推定)

2027年10月1日

試験登録日

最初に提出

2026年3月4日

QC基準を満たした最初の提出物

2026年6月9日

最初の投稿 (実際)

2026年6月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月12日

QC基準を満たした最後の更新が送信されました

2026年6月9日

最終確認日

2026年6月1日

詳しくは

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いいえ

米国FDA規制機器製品の研究

いいえ

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