To compare a strategy using high PEEP (10 cmH2O) with recruitment maneuvers versus low PEEP (5 cmH2O) without recruitment maneuvers, during thoracic surgery under standardized one lung ventilation with low VT (5 mL/kg predicted body weight - PBW) in…
ID
Source
Brief title
Condition
- Other condition
- Procedural related injuries and complications NEC
Synonym
Health condition
Mechanical one lung ventilation and post-operative Pulmonary complications
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The proportion of patients developing one or more PPCs
Secondary outcome
• intraoperative complications
• postoperative extra-pulmonary complications
• extended PPCs
• need for unexpected ICU admission or ICU readmission
• number of hospital-free days at day 28
• 90-day survival
• arterial blood gas analysis during OLV, TLV (pCO2, pO2, pH)
• any postoperative respiratory intervention (e.g. NIV or CPAP or intubation or
High Flow Nasal Cannula)
Background summary
One-lung ventilation (OLV) with resting of the contralateral lung may be
required to allow or facilitate thoracic surgery. However, OLV can result in
severe hypoxemia, requiring a mechanical ventilation approach that is able to
maintain adequate gas exchange, while protecting the lungs against
postoperative pulmonary complications (PPCs). During OLV, the use of lower
tidal volumes (VT) is helpful to avoid over-distension, but can result in
increased atelectasis and repetitive collapse-and-reopening of lung units,
particularly at low levels of positive end-expiratory pressure (PEEP).
Nevertheless, it is not known if, during OLV with low VT, high levels of PEEP
combined with lung recruitment maneuvers are superior to low to moderate PEEP
for protection against PPCs.
Study objective
To compare a strategy using high PEEP (10 cmH2O) with recruitment maneuvers
versus low PEEP (5 cmH2O) without recruitment maneuvers, during thoracic
surgery under standardized one lung ventilation with low VT (5 mL/kg predicted
body weight - PBW) in adults.
Study design
An international multicenter double blind randomized controlled trial.
Intervention
Randomisation to high versus low PEEP during one-lung ventilation for Thoracic
surgery
Study burden and risks
A particular advantage for all patients participating in this study is that
they can benefit from extended monitoring during and after the operation.
Nevertheless, there are different risks and benefits for both groups.
Low-pressure ventilation group: will be given the ventilation treatment that is
preferred by most of the anesthesists all over the world. During low pressure
ventilation, the oxygen content in the blood may be too low so that the
respiratory gas mixture or respiratory pressure has to be adapted. A particular
advantage of this form of ventilation is that the circulation is somewhat more
stable.
Higher pressure ventilation: the air passages may well be held open, which is
likley to help the transfer of oxygen. However, a transient drop in blood
pressure may occur, which can be easily treated by the administration of
specific drugs. These drugs occasionally lead to a reduction of the heart rate,
which does not cause damage. If a situation develops with impaired lung
function or depression of the cardiocirculatory system, the applied ventilation
pressure will be adapted to restore proper function.
The discharge from the hospital is not delayed due to participation in the
study and no additional examinations after hosptal discharge are made.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
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
• planned lung separation with double lumen tube (DLT, not for study purpose
only)
• most of ventilation time during surgery expected to be in OLV
Exclusion criteria
• COPD GOLD grades III and IV, lung fibrosis, documented bullae, severe
emphysema, pneumothorax
• uncontrolled asthma
• Heart failure NYHA Grade 3 and 4, Coronary Heart Disease CCS Grade 3 and 4
• previous lung surgery
• documented pulmonary arterial hypertension >25mmHg MPAP at rest or > 40 mmHg
syst. (estimated by ultrasound)
• documented or suspected neuromuscular disease (thymoma, myasthenia,
myopathies, muscular dystrophies, others)
• planned mechanical ventilation after surgery
• bilateral procedures
• lung separation with other method than DLT (e.g. difficult airway,
tracheostomy)
• 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)
• esophagectomy, pleural surgery only, sympathectomy surgery only, chest wall
surgery only, mediastinal surgery only, lung transplantation
• presence before induction of anaesthesia of one of the adverse events, listed
as postoperative pulmonary complications (aspiration, moderate respiratory
failure, infiltrates, pulmonary infection, atelectasis, cardiopulmonary edema,
pleural effusion, pneumothorax, pulmonary embolism, purulent pleuritis, lung
hemorrhage)
• documented preoperative hypercapnia > 45mmHg (6kPa)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02963025 |
| CCMO | NL62625.018.17 |