免费获得国外相关药品，最快 1 个工作日回馈药物信息
Effect of Lung Protective One-lung Ventilation With Fix and Variable PEEP on Oxygenation and Outcome
During One-lung ventilation, the use of lower tidal volumes (VT) is helpful to avoid over-distension, provide sufficient oxygenation, but can result in increased atelectasis.
Nevertheless, it is not known if, during one-lung ventilation with constant low VT, moderate levels of PEEP combined with lung recruitment maneuvers are superior to variable PEEP for intraoperative oxygenation and protection against PPCs.
Aim of the study is to compare a strategy using constant tidal volume with recruitment maneuvers versus variable PEEP with recruitment maneuvers during thoracic surgery in adults.
The investigators hypothesize that in adult, non-obese patients undergoing thoracic surgery under standardized OLV with variable PEEP and recruitment maneuvers as compared to constant PEEP without recruitment maneuvers prevent PPCs.
Patients will be randomly assigned to one of two groups:
FIX TIDAL VOLUME GROUP (Groupfix): mechanical ventilation with constant (6 ml/kgIBW) tidal volume and PEEP of 5 cmH2O with recruitment maneuvers
VARIABLE TIDAL VOLUME GROUP (Groupvar): mechanical ventilation with constant (6 ml/kgIBW) tidal volume with variable PEEP with recruitment maneuvers.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypoxemia Pulmonary Sepsis ARDS, Human Pneumonia | Other: Change of ventilatory settings | Not Applicable |
Lung separation will be performed by DLT technique. Mechanical ventilation will be applied in volume-controlled mode. During two-lung ventilation, VT will be set at 8 mL/kg predicted body weight. During one-lung ventilation, in GroupFix VT will be decreased to 6 mL/kg PBW with 5 cmH2O PEEP.
In GroupVar VT mechanical ventilation with constant (6 ml/kgIBW) tidal volume with variable PEEP with recruitment maneuvers.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 130 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Prevention |
| Official Title: | Effect of Lung Protective One-lung Ventilation With Fix and Variable Positive End-expiratory Pressure (PEEP) on Oxygenation and Outcome: Randomized, Controlled Trial |
| Actual Study Start Date : | February 1, 2018 |
| Estimated Primary Completion Date : | May 31, 2019 |
| Estimated Study Completion Date : | May 31, 2019 |
| Arm | Intervention/treatment |
|---|---|
|
No Intervention: Group Fix:One-lung ventilation with constant PEEP
Controll group: lung protective one-lung ventilation with fix positive end-expiratory pressure (PEEP)
|
|
|
Active Comparator: Group Variable:One-lung ventilation with variable PEEP
Variable group: lung protective one-lung ventilation with variable positive end-expiratory pressure (PEEP)
|
Other: Change of ventilatory settings
Change of Positive End-Exspiratory Pressure during one-lung ventilation
|
- Intraoperative oxygenation [ Time Frame: 1 day ]PaO2 < 60 mmHg
- Postoperative pulmonary complications [ Time Frame: 90 days ]Infiltrate on chest X-ray, fever, laboratory and physical signs of infection
- Postoperative extra-pulmonary complications [ Time Frame: 90 days ]new atrial fibrillation
- 30 day survival/mortality [ Time Frame: 30 days ]number of death within 30 days after surgery
- 90 day survival/mortality [ Time Frame: 90 days ]number of death within 90 days after surgery
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient scheduled for open thoracic or video-assisted thoracoscopic surgery under general anesthesia requiring OLV (no emergency surgery)
- BMI < 35 kg/m2
- Age ≥ 18 years
- Expected duration of surgery > 60 min
- Expected duration of anesthesia > 90 min
Exclusion Criteria:
- COPD GOLD 3+4, lung fibrosis, documented bullae, severe emphysema, pneumothorax
- uncontrolled asthma
- NYHA 3+4, CCS 3+4
- previous thoracic surgery
- ARDS (Berlin definition)
- documented pulmonary arterial hypertension > 40 mmHg syst
- documented or suspected neuromuscular disease (thymoma, myasthenia)
- planned mechanical ventilation after surgery
- bilateral procedures
- lung separation with other method than DLT (eg diff. airway, trachestomy)
- surgery in prone position
- persistent hemodynamic instability, intractable shock
- intracranial injury or tumor
- enrollment in other interventional study or refusal of informed consent
- pregnancy (excluded by anamnesis and/or laboratory analysis)
| Hungary | |
| University of Debrecen, Department of Anaesthesiology and Intensive Care | |
| Debrecen, Hungary, 4032 | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 14, 2019 | ||||
| First Posted Date ICMJE | May 30, 2019 | ||||
| Last Update Posted Date | May 30, 2019 | ||||
| Actual Study Start Date ICMJE | February 1, 2018 | ||||
| Estimated Primary Completion Date | May 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Intraoperative oxygenation [ Time Frame: 1 day ] PaO2 < 60 mmHg
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Lung Protective One-lung Ventilation With Fix and Variable PEEP on Oxygenation and Outcome | ||||
| Official Title ICMJE | Effect of Lung Protective One-lung Ventilation With Fix and Variable Positive End-expiratory Pressure (PEEP) on Oxygenation and Outcome: Randomized, Controlled Trial | ||||
| Brief Summary |
During One-lung ventilation, the use of lower tidal volumes (VT) is helpful to avoid over-distension, provide sufficient oxygenation, but can result in increased atelectasis. Nevertheless, it is not known if, during one-lung ventilation with constant low VT, moderate levels of PEEP combined with lung recruitment maneuvers are superior to variable PEEP for intraoperative oxygenation and protection against PPCs. Aim of the study is to compare a strategy using constant tidal volume with recruitment maneuvers versus variable PEEP with recruitment maneuvers during thoracic surgery in adults. The investigators hypothesize that in adult, non-obese patients undergoing thoracic surgery under standardized OLV with variable PEEP and recruitment maneuvers as compared to constant PEEP without recruitment maneuvers prevent PPCs. Patients will be randomly assigned to one of two groups: FIX TIDAL VOLUME GROUP (Groupfix): mechanical ventilation with constant (6 ml/kgIBW) tidal volume and PEEP of 5 cmH2O with recruitment maneuvers VARIABLE TIDAL VOLUME GROUP (Groupvar): mechanical ventilation with constant (6 ml/kgIBW) tidal volume with variable PEEP with recruitment maneuvers. |
||||
| Detailed Description |
Lung separation will be performed by DLT technique. Mechanical ventilation will be applied in volume-controlled mode. During two-lung ventilation, VT will be set at 8 mL/kg predicted body weight. During one-lung ventilation, in GroupFix VT will be decreased to 6 mL/kg PBW with 5 cmH2O PEEP. In GroupVar VT mechanical ventilation with constant (6 ml/kgIBW) tidal volume with variable PEEP with recruitment maneuvers. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Prevention |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Other: Change of ventilatory settings
Change of Positive End-Exspiratory Pressure during one-lung ventilation
|
||||
| Study Arms ICMJE |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Unknown status | ||||
| Actual Enrollment ICMJE |
130 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | May 31, 2019 | ||||
| Estimated Primary Completion Date | May 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender ICMJE |
|
||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Hungary | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03968120 | ||||
| Other Study ID Numbers ICMJE | DE RKEB/IKEB 4918-2017 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Tamas Vegh, MD, University of Debrecen | ||||
| Study Sponsor ICMJE | University of Debrecen | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | University of Debrecen | ||||
| Verification Date | May 2019 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||
