Trial Outcomes & Findings for Prospective Evaluation of a RIsk Score for Postoperative Pulmonary COmPlications in Europe (NCT NCT01346709)
NCT ID: NCT01346709
Last Updated: 2022-04-05
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
5450 participants
Primary outcome timeframe
Postoperative in-hospital stay up to 5 weeks
Results posted on
2022-04-05
Participant Flow
1 week chosen by each centre First Sub First Visit 4-Apr-11 Last data entered 25 Oct 2011
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
5450
|
|
Overall Study
COMPLETED
|
5099
|
|
Overall Study
NOT COMPLETED
|
351
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Protocol Violation
|
35
|
|
Overall Study
Lost to Follow-up
|
31
|
|
Overall Study
Missing data in candidate risk factor
|
285
|
Baseline Characteristics
Prospective Evaluation of a RIsk Score for Postoperative Pulmonary COmPlications in Europe
Baseline characteristics by cohort
| Measure |
In-patient Adult Non-obstetricSurgical
n=5099 Participants
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.
|
|---|---|
|
Age, Customized
<=50years
|
1763 participants
n=5 Participants
|
|
Age, Customized
51-80years
|
2944 participants
n=5 Participants
|
|
Age, Customized
>80years
|
392 participants
n=5 Participants
|
|
Age, Customized
Age Median
|
59.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2493 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2606 Participants
n=5 Participants
|
|
Body Mass Index
|
26.2 kg/m^2
n=5 Participants
|
|
Smoking status
Never Smoker
|
2674 participants
n=5 Participants
|
|
Smoking status
Former Smoker
|
1245 participants
n=5 Participants
|
|
Smoking status
Current Smoker
|
1180 participants
n=5 Participants
|
|
Chronic obstructive pulmonary disease (COPD)
COPD = yes
|
517 participants
n=5 Participants
|
|
Chronic obstructive pulmonary disease (COPD)
COPD = no
|
4582 participants
n=5 Participants
|
|
Functional Status
Independant
|
4561 participants
n=5 Participants
|
|
Functional Status
Partally/totally dependant
|
538 participants
n=5 Participants
|
|
Hypertension
Hypertension = yes
|
2191 participants
n=5 Participants
|
|
Hypertension
Hypertension = no
|
2908 participants
n=5 Participants
|
|
Heart Failure
Heart Failure = yes
|
800 participants
n=5 Participants
|
|
Heart Failure
Heart Failure = no
|
4299 participants
n=5 Participants
|
|
Coronary artery disease
Coronary artery disease = yes
|
647 participants
n=5 Participants
|
|
Coronary artery disease
Coronary artery disease = no
|
4452 participants
n=5 Participants
|
|
Cerebrovascular disease
Cerebrovascular disease = yes
|
654 participants
n=5 Participants
|
|
Cerebrovascular disease
Cerebrovascular disease = no
|
4445 participants
n=5 Participants
|
|
Liver disease
Liver disease = yes
|
292 participants
n=5 Participants
|
|
Liver disease
Liver disease = no
|
4807 participants
n=5 Participants
|
|
Chronic kidney disease
Chronic kidney disease = yes
|
258 participants
n=5 Participants
|
|
Chronic kidney disease
Chronic kidney disease = no
|
4841 participants
n=5 Participants
|
|
Respiratory Infection in the last month
Respiratory Infection in the last month = yes
|
287 participants
n=5 Participants
|
|
Respiratory Infection in the last month
Respiratory Infection in the last month = no
|
4812 participants
n=5 Participants
|
|
Preoperative SpO2 (Peripheral capillary oxygen saturation)
|
97 Percentage
n=5 Participants
|
|
Anemia (<10g/dl)
Anemia (<10g/dl) = yes
|
223 participants
n=5 Participants
|
|
Anemia (<10g/dl)
Anemia (<10g/dl) = no
|
4876 participants
n=5 Participants
|
|
Geografical Location of Centres
Spain Centres
|
2000 participants
n=5 Participants
|
|
Geografical Location of Centres
Western Europe Centres
|
1538 participants
n=5 Participants
|
|
Geografical Location of Centres
Eastern Europe Centres
|
1561 participants
n=5 Participants
|
|
ASA physical status
1
|
1115 participants
n=5 Participants
|
|
ASA physical status
2
|
2604 participants
n=5 Participants
|
|
ASA physical status
3
|
1280 participants
n=5 Participants
|
|
ASA physical status
4
|
100 participants
n=5 Participants
|
|
Anaesthesia
General and combined
|
3890 participants
n=5 Participants
|
|
Anaesthesia
Neuraxial/regional
|
1209 participants
n=5 Participants
|
|
Emergency Surgery
Emergency Surgery = yes
|
566 participants
n=5 Participants
|
|
Emergency Surgery
Emergency Surgery = no
|
4533 participants
n=5 Participants
|
|
Surgical specialty
Orthopedic
|
998 participants
n=5 Participants
|
|
Surgical specialty
General and digestive
|
1362 participants
n=5 Participants
|
|
Surgical specialty
Urology
|
674 participants
n=5 Participants
|
|
Surgical specialty
Gynecology
|
426 participants
n=5 Participants
|
|
Surgical specialty
Ear, nose, throat
|
307 participants
n=5 Participants
|
|
Surgical specialty
Vascular
|
201 participants
n=5 Participants
|
|
Surgical specialty
Breast
|
153 participants
n=5 Participants
|
|
Surgical specialty
Cardiac
|
161 participants
n=5 Participants
|
|
Surgical specialty
Thoracic
|
142 participants
n=5 Participants
|
|
Surgical specialty
Neurosurgery
|
320 participants
n=5 Participants
|
|
Surgical specialty
Other
|
355 participants
n=5 Participants
|
|
Surgical Incision
Peripheral
|
3695 participants
n=5 Participants
|
|
Surgical Incision
Upper abdominal
|
1092 participants
n=5 Participants
|
|
Surgical Incision
Intrathoracic/cardiac
|
312 participants
n=5 Participants
|
|
Duration of Surgery (h) median
|
1.3 hours
n=5 Participants
|
PRIMARY outcome
Timeframe: Postoperative in-hospital stay up to 5 weeksPopulation: PPC incidence, Percentage in Patients valid for external validation study
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.
Outcome measures
| Measure |
In-patient Adult Non-obstetricSurgical
n=5099 Participants
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.
|
|---|---|
|
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
Interval 7.2 to 8.7
|
SECONDARY outcome
Timeframe: Postoperative in-hospital stay up to 90 daysParticipants will be followed for the duration of in-hospital stay up to 90 days
Outcome measures
| Measure |
In-patient Adult Non-obstetricSurgical
n=5099 Participants
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.
|
|---|---|
|
a) Postoperative Length of Stay
|
4 days
Interval 2.0 to 7.0
|
SECONDARY outcome
Timeframe: Postoperative in-hospital stay up to 90 daysParticipants will be followed for the duration of in-hospital stay up to 90 days
Outcome measures
| Measure |
In-patient Adult Non-obstetricSurgical
n=5099 Participants
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.
|
|---|---|
|
b) In-hospital Mortality
|
0.9 percentage of Participants
|
Adverse Events
Observational Study Section Not Applicable
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Brigitte Leva, Research Team Leader
European Society of anaesthesiology
Phone: +3222109414
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place