Prospective Evaluation of a RIsk Score… | Clinical Trial

Key information

Conditions

Complication of Surgical Procedure Acute Lung Injury Acute Respiratory Failure, Adult Bronchial Diseases Bronchial Spasm Infections Lung Diseases Lung Injury Pleural Diseases Pleural Effusion Pneumonia Pneumonia, Aspiration Pneumothorax Postoperative Respiratory Complications Pulmonary Atelectasis Pulmonary Failure Respiration Disorders Respiratory Distress Syndrome Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Surgical Complications From General Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital centre "Mother Theresa" Anesthesia & critical Care, Tirana, Albania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

age <18 years
obstetric procedures or any procedure during pregnancy
regional anaesthesia alone, except to neuroaxial and plexus anaesthesia
procedures outside the operating room
procedures related to a previous postoperative complication
transplantation
patients with preoperatively intubated trachea
outpatient procedures, defined as those requiring less than one day's stay for a patient alive at discharge.

Treatment and study plan

Primary outcomes

The Main Outcome, Defined as a Postoperative Pulmonary Complications (PPC), Will be a Composite of the In-hospital Fatal or Non-fatal Postoperative Events.

Time frame: 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 outcomes

a) Postoperative Length of Stay

Time frame: 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

Time frame: Postoperative in-hospital stay up to 90 days

Participants will be followed for the duration of in-hospital stay up to 90 days

Sponsors and collaborators

Lead sponsor

European Society of Anaesthesiology

Other

Registry information

Official study title

Prospective Evaluation of a RIsk Score for Postoperative Pulmonary COmPlications in Europe: Predicting Postoperative Pulmonary Complications in Europe: a 7-day Data Collection, Prospective, Observational Study

Acronym: PERISCOPE

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: May 3, 2011
Registry last updated: Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed