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Effects of Postoperative Residual Paralysis on Hospital Costs

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Matthias Eikermann, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01718860
First received: October 29, 2012
Last updated: May 1, 2017
Last verified: May 2017
October 29, 2012
May 1, 2017
April 2011
February 2014   (Final data collection date for primary outcome measure)
Hospital costs [ Time Frame: Patients will be followed from date of admission to date of hospital discharge, an expected 2 days to 4 weeks ]
Impaired gas exchange [ Time Frame: Within 10 min. upon PACU arrival ]
Gas exchange is assessed by a ratio of pulse oxymetry oxygen saturation relative to fraction of inspired oxygen. Oxygen saturation at PACU admission is defined as the first oxygen saturation value written by an independent nurse in patients' clinical PACU note.
Complete list of historical versions of study NCT01718860 on ClinicalTrials.gov Archive Site
Hospital Length of Stay [ Time Frame: within 100 days after surgery ]
Hospital Length of Stay [ Time Frame: within 100 days after surgery ]
Hospital length of stay is defined as the length from the day of the surgery to hospital discharge.
  • Incidence of postoperative respiratory complications [ Time Frame: Within one month after surgery ]
  • Incidence of unplanned postoperative intensive care unit admission [ Time Frame: Within one week after surgery ]
    Incidence of unplanned postoperative intensive care unit admission due to respiratory failure, pulmonary edema and arrhythmia.
  • Length of stay in the post-anesthesia care unit (PACU) [ Time Frame: Patients will be followed until PACU discharge, an expected 2 days to 2 weeks ]
  • Incidence of postoperative atelectasis [ Time Frame: Within one month after surgery ]
    Diagnosis of atelectasis will be retrieved from the hospital billing data.
  • Incidence of unplanned postoperative intensive care unit admission [ Time Frame: Withing one week after surgery ]
    Incidence of unplanned postoperative intensive care unit admission due to respiratory failure, pulmonary edema and arrhythmia.
 
Effects of Postoperative Residual Paralysis on Hospital Costs
Effects of Postoperative Residual Paralysis on Costs of Hospital Care, Length of Hospitalization and Intensive Care Unit Admission Rate

This is a secondary analysis of a previously performed prospective, observer-blinded, observational study at Massachusetts General Hospital. The primary aim of this study is to evaluate the effects of residual paralysis at admission to the post-anesthesia care unit (PACU) on total costs of hospital care.

Secondary analyses will be conducted to evaluate the effects of postoperative residual paralysis on potential cost-influencing factors, i.e. incidence of minor and major postoperative respiratory complications, hospital length of stay (LOS), unplanned intensive care unit (ICU) admission rate, as well as length of stay in the PACU.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Adult patients who arrived at the post-anesthesia care unit after receiving neuromuscular blocking agents as part of their surgical anaesthesia.
Residual Paralysis, Post-Anesthesia
Procedure: Quantitative measurement of neuromuscular transmission
Quantitative measurement of neuromuscular transmission with train-of-four watches.
  • Postoperative Residual Paralysis
    Patients with train-of-four ratio less than 0.9 measured in the postanesthesia care unit
    Intervention: Procedure: Quantitative measurement of neuromuscular transmission
  • No Postoperative Residual Paralysis
    Patients with train-of-four ratio greater than 0.9 measured in the postanesthesia care unit
    Intervention: Procedure: Quantitative measurement of neuromuscular transmission

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3000
December 2017
February 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Each subject has been given non-depolarizing neuromuscular blocking agents as part of general anesthesia.
  • Each subject must be at least 18 years of age
  • Train-of-four monitoring in the post-anesthesia care unit

Exclusion Criteria:

  • The subject is scheduled to be transferred to an intensive care unit after surgery.
  • Children and pregnant women
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01718860
2016P002695
IISP#39443 ( Other Grant/Funding Number: MERCK & CO INC )
No
Not Provided
Plan to Share IPD: No
Matthias Eikermann, Massachusetts General Hospital
Massachusetts General Hospital
Merck Sharp & Dohme Corp.
Principal Investigator: Matthias Eikermann, MD, PhD Partners
Massachusetts General Hospital
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP