Acute Respiratory Failure, Adult, Complication of Surgical Procedure, Postoperative Respiratory Complications, Pulmonary Failure, Surgical Complications From General Anesthesia
Conditions
Keywords
Operative surgical procedures, Postoperative pulmonary complications (PPC), Epidemiological Study, ARISCAT score, Risk Score, Europe, PERISCOPE, observational study, Mild respiratory failure, Severe respiratory failure, acute lung injury (ALI), Acute respiratory distress syndrome (ARDS), Suspected pulmonary infection, Pulmonary infiltrate, Pleural effusion, Atelectasis, Pneumothorax, Bronchospasm, Aspiration Pneumonitis, Cardiopulmonary edema, Prospective Evaluation, nonobstetric in-hospital surgical procedure, general or regional anaesthesia, continued 7-day period recruitment
Brief summary
Prospective Evaluation of a RIsk Score for postoperative pulmonary COmPlications in Europe (PERISCOPE) is a multi-centre, international observational study of a random-sample cohort of patients undergoing a nonobstetric in-hospital surgical procedure under general or regional anaesthesia during a continued 7-day period of recruitment.
Detailed description
Prospective Evaluation of a RIsk Score for postoperative pulmonary COmPlications in Europe (PERISCOPE) is a multi-centre, international observational study of a random-sample cohort of patients undergoing a nonobstetric in-hospital surgical procedure under general or regional anaesthesia during a continued 7-day period of recruitment. Participating centres throughout Europe will contribute routine clinical data describing all eligible patients who undergo surgery during a continuous week (7-days) at convenience of every department within a period of two months from May 1st to July 1st 2011. A questionnaire of around 50 items will be filled during the pre, intra and postoperative periods. The follow-up will end at discharge. The aim of the PERISCOPE study is to validate a simple score to predict postoperative pulmonary complications(PPCs). This score has recently been published in Anesthesiology and you can access linking to: http://journals.lww.com/anesthesiology/Fulltext/2010/12000/Prediction\_of\_Postoperative\_Pulmonary.20.aspx TIMEFRAME Participants will be followed for the duration of in-hospital stay, an expected average of maximum 5 weeks.
Interventions
None listed
Sponsors
European Society of Anaesthesiology
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients undergoing a non-obstetric in-hospital surgical procedure, elective or emergent, under general anaesthesia (alone or in combination with regional/neuraxial anaesthesia), neuraxial anaesthesia or plexus block (with and without sedation).
Exclusion criteria
1. age \<18 years 2. obstetric procedures or any procedure during pregnancy 3. regional anaesthesia alone, except to neuroaxial and plexus anaesthesia 4. procedures outside the operating room 5. procedures related to a previous postoperative complication 6. transplantation 7. patients with preoperatively intubated trachea 8. outpatient procedures, defined as those requiring less than one day's stay for a patient alive at discharge.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Main Outcome, Defined as a Postoperative Pulmonary Complications (PPC), Will be a Composite of the In-hospital Fatal or Non-fatal Postoperative Events. | Postoperative in-hospital stay up to 5 weeks | Will include:Mild respiratory failure;Severe respiratory failure;acute lung injury(ALI)/Acute respiratory distress syndrome(ARDS);Suspected pulmonary infection;Pulmonary infiltrate;Pleural effusion;Atelectasis;Pneumothorax;Bronchospasm;Aspiration Pneumonitis;Cardiopulmonary edema.Investigators will not modify centre usual patient management. Patients with PPCs will identify by consulting medical records and looking for events fulfilling PPCdefinition. Diagnosis date for every complication will be recorded.Participants will be followed during in-hospital stay up to 5 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| a) Postoperative Length of Stay | Postoperative in-hospital stay up to 90 days | Participants will be followed for the duration of in-hospital stay up to 90 days |
| b) In-hospital Mortality | Postoperative in-hospital stay up to 90 days | Participants will be followed for the duration of in-hospital stay up to 90 days |
Countries
Albania, Belgium, Bosnia and Herzegovina, Croatia, Czechia, Estonia, France, Germany, Hungary, Italy, Latvia, Lithuania, Luxembourg, Poland, Portugal, Romania, Russia, Spain, Switzerland, Turkey (Türkiye), Ukraine
Participant flow
Recruitment details
1 week chosen by each centre First Sub First Visit 4-Apr-11 Last data entered 25 Oct 2011
Participants by arm
| Arm | Count |
|---|---|
| In-patient Adult Non-obstetricSurgical Consecutive patients admitted to participating centres undergoing surgery Non-obstetric in-hospital surgical procedure, elective or emergent, under general anaesthesia (alone or in combination with regional/neuraxial anaesthesia), neuraxial anaesthesia or plexus block (with and without sedation).
All eligible patients undergoing surgery within the seven day study period will be recruited wherever possible. | 5,099 |
| Total | 5,099 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 31 |
| Overall Study | Missing data in candidate risk factor | 285 |
| Overall Study | Protocol Violation | 35 |
Baseline characteristics
| Characteristic | In-patient Adult Non-obstetricSurgical |
|---|---|
| Age, Customized <=50years | 1763 participants |
| Age, Customized 51-80years | 2944 participants |
| Age, Customized >80years | 392 participants |
| Age, Customized Age Median | 59.1 years |
| Anaesthesia General and combined | 3890 participants |
| Anaesthesia Neuraxial/regional | 1209 participants |
| Anemia (<10g/dl) Anemia (<10g/dl) = no | 4876 participants |
| Anemia (<10g/dl) Anemia (<10g/dl) = yes | 223 participants |
| ASA physical status 1 | 1115 participants |
| ASA physical status 2 | 2604 participants |
| ASA physical status 3 | 1280 participants |
| ASA physical status 4 | 100 participants |
| Body Mass Index | 26.2 kg/m^2 |
| Cerebrovascular disease Cerebrovascular disease = no | 4445 participants |
| Cerebrovascular disease Cerebrovascular disease = yes | 654 participants |
| Chronic kidney disease Chronic kidney disease = no | 4841 participants |
| Chronic kidney disease Chronic kidney disease = yes | 258 participants |
| Chronic obstructive pulmonary disease (COPD) COPD = no | 4582 participants |
| Chronic obstructive pulmonary disease (COPD) COPD = yes | 517 participants |
| Coronary artery disease Coronary artery disease = no | 4452 participants |
| Coronary artery disease Coronary artery disease = yes | 647 participants |
| Duration of Surgery (h) median | 1.3 hours |
| Emergency Surgery Emergency Surgery = no | 4533 participants |
| Emergency Surgery Emergency Surgery = yes | 566 participants |
| Functional Status Independant | 4561 participants |
| Functional Status Partally/totally dependant | 538 participants |
| Geografical Location of Centres Eastern Europe Centres | 1561 participants |
| Geografical Location of Centres Spain Centres | 2000 participants |
| Geografical Location of Centres Western Europe Centres | 1538 participants |
| Heart Failure Heart Failure = no | 4299 participants |
| Heart Failure Heart Failure = yes | 800 participants |
| Hypertension Hypertension = no | 2908 participants |
| Hypertension Hypertension = yes | 2191 participants |
| Liver disease Liver disease = no | 4807 participants |
| Liver disease Liver disease = yes | 292 participants |
| Preoperative SpO2 (Peripheral capillary oxygen saturation) | 97 Percentage |
| Respiratory Infection in the last month Respiratory Infection in the last month = no | 4812 participants |
| Respiratory Infection in the last month Respiratory Infection in the last month = yes | 287 participants |
| Sex: Female, Male Female | 2493 Participants |
| Sex: Female, Male Male | 2606 Participants |
| Smoking status Current Smoker | 1180 participants |
| Smoking status Former Smoker | 1245 participants |
| Smoking status Never Smoker | 2674 participants |
| Surgical Incision Intrathoracic/cardiac | 312 participants |
| Surgical Incision Peripheral | 3695 participants |
| Surgical Incision Upper abdominal | 1092 participants |
| Surgical specialty Breast | 153 participants |
| Surgical specialty Cardiac | 161 participants |
| Surgical specialty Ear, nose, throat | 307 participants |
| Surgical specialty General and digestive | 1362 participants |
| Surgical specialty Gynecology | 426 participants |
| Surgical specialty Neurosurgery | 320 participants |
| Surgical specialty Orthopedic | 998 participants |
| Surgical specialty Other | 355 participants |
| Surgical specialty Thoracic | 142 participants |
| Surgical specialty Urology | 674 participants |
| Surgical specialty Vascular | 201 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
The Main Outcome, Defined as a Postoperative Pulmonary Complications (PPC), Will be a Composite of the In-hospital Fatal or Non-fatal Postoperative Events.
Will include:Mild respiratory failure;Severe respiratory failure;acute lung injury(ALI)/Acute respiratory distress syndrome(ARDS);Suspected pulmonary infection;Pulmonary infiltrate;Pleural effusion;Atelectasis;Pneumothorax;Bronchospasm;Aspiration Pneumonitis;Cardiopulmonary edema.Investigators will not modify centre usual patient management. Patients with PPCs will identify by consulting medical records and looking for events fulfilling PPCdefinition. Diagnosis date for every complication will be recorded.Participants will be followed during in-hospital stay up to 5 weeks.
Time frame: Postoperative in-hospital stay up to 5 weeks
Population: PPC incidence, Percentage in Patients valid for external validation study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In-patient Adult Non-obstetricSurgical | The Main Outcome, Defined as a Postoperative Pulmonary Complications (PPC), Will be a Composite of the In-hospital Fatal or Non-fatal Postoperative Events. | 7.92 Percentage of Participants |
Secondary
a) Postoperative Length of Stay
Participants will be followed for the duration of in-hospital stay up to 90 days
Time frame: Postoperative in-hospital stay up to 90 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| In-patient Adult Non-obstetricSurgical | a) Postoperative Length of Stay | 4 days |
Secondary
b) In-hospital Mortality
Participants will be followed for the duration of in-hospital stay up to 90 days
Time frame: Postoperative in-hospital stay up to 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In-patient Adult Non-obstetricSurgical | b) In-hospital Mortality | 0.9 percentage of Participants |