NCT01865513

Brief Summary

International multicenter observational study of a random-sample cohort of patients undergoing any in-hospital surgical procedure under general or regional anaesthesia during a continued 14-day period of recruitment. Primary hypothesis of this study is that the use of muscle relaxants, their reversal agents, or neuromuscular monitoring increases the incidence of postoperative pulmonary complications. The secondary hypothesis is that the use of muscle relaxants increases in-hospital mortality.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2014

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
1 year until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

10 months

First QC Date

May 28, 2013

Last Update Submit

October 13, 2015

Conditions

Surgical Procedures, OperativeAnaesthesia

Keywords

AnaesthesiaAnaesthesiologymuscle RelaxantsPOPULARpostoperative pulmonary complicationsRespiratory failureSuspected pulmonary infectionPulmonary infiltratesPleural effusionAtelectasisPneumothoraxBronchospasmAspiration pneumonitisCardiopulmonary oedemaEuropean Society of Anaesthesiologyneuromuscular blockadeeurope

Outcome Measures

Primary Outcomes (1)

  • The primary study outcome parameter is the rate of post-operative pulmonary Complications (POPC).

    Post-operative pulmonary Complications (POPC) is a composite of in-hospital fatal or non-fatal postoperative pulmonary events. A patient is assumed to have POPC if at least one of the following complications is documented: POPC is defined as a composite of in-hospital fatal or non-fatal postoperative pulmonary or respiratory events: Respiratory failure Suspected pulmonary infection, i.e. Suspected pulmonary infiltrates Atelectasis Aspiration pneumonitis Bronchospasm Pulmonary Oedema

    up to 28 days after surgery

Secondary Outcomes (2)

  • in-hospital mortality

    up to 28 days after surgery

  • length of in-hospital stay

    up to 28 days after surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult Patients undergoing any in-hospital surgical procedure under general or regional anaesthesia

You may qualify if:

  • Adult Patients undergoing any in-hospital surgical procedure under general or regional anaesthesia during the defined continued 14-day period of recruitment.

You may not qualify if:

  • Patients less than 18 years of age
  • Patients scheduled for local or regional anaesthesia only
  • Patient's anaesthetic procedure scheduled outside an operating room
  • Ambulatory patients = Patient planned to be discharged within 12 hours post anaesthesia
  • Patient with preoperatively intubated trachea
  • Patient from an intensive care unit (ICU)
  • Patient scheduled for additional surgical / anaesthetic procedure in the next 7 days
  • Patients who had a surgical / anaesthetic procedure within the past 7 days
  • Patient born outside the predetermined 'month(s)' allocated for the specific study centre.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Klinikum rechts der Isar, Technische Universität München

München, 81675, Germany

Location

Karolinska Institutet and Karolinska University Hospital

Stockholm, 171 76, Sweden

Location

Related Publications (2)

  • Blobner M, Hunter JM, Meistelman C, Hoeft A, Hollmann MW, Kirmeier E, Lewald H, Ulm K. Use of a train-of-four ratio of 0.95 versus 0.9 for tracheal extubation: an exploratory analysis of POPULAR data. Br J Anaesth. 2020 Jan;124(1):63-72. doi: 10.1016/j.bja.2019.08.023. Epub 2019 Oct 10.

    PMID: 31607388DERIVED

  • Kirmeier E, Eriksson LI, Lewald H, Jonsson Fagerlund M, Hoeft A, Hollmann M, Meistelman C, Hunter JM, Ulm K, Blobner M; POPULAR Contributors. Post-anaesthesia pulmonary complications after use of muscle relaxants (POPULAR): a multicentre, prospective observational study. Lancet Respir Med. 2019 Feb;7(2):129-140. doi: 10.1016/S2213-2600(18)30294-7. Epub 2018 Sep 14.

    PMID: 30224322DERIVED

MeSH Terms

Conditions

Muscle HypotoniaRespiratory InsufficiencyPleural EffusionPulmonary AtelectasisPneumothoraxBronchial SpasmPneumonia, Aspiration

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesPleural DiseasesLung DiseasesBronchial DiseasesPneumoniaRespiratory Tract InfectionsInfections

Study Officials

  • Manfred Blobner, M.D.

    Klinikum rechts der Isar Technische Universität München

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2013

First Posted

May 31, 2013

Study Start

June 1, 2014

Primary Completion

April 1, 2015

Study Completion

August 1, 2015

Last Updated

October 14, 2015

Record last verified: 2015-10

Locations

DE(1)SE(1)