Accuracy of Pleth Variability Index (PVI) in Predicting Response to Intravenous Fluid load During Scoliosis Surgery in Children.

Study identification

• EU PAS number:
  EUPAS3238
• Study ID:
  3239
• Official title and acronym:
  Accuracy of Pleth Variability Index (PVI) in Predicting Response to Intravenous Fluid load During Scoliosis Surgery in Children.
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  This study is an observational non-intervention study. This work aim to study the accuracy of Plethysmographic Variability Index (PVI) during scoliosis surgery in children.It consists on an observational study on PVI values before fluid challenges (using 20 ml/Kg of a normal saline solution) performed during this surgical procedure. The goal standard for a response to a fluid challenge is an increase of the indexed stroke volume (determined using an oesophageal doppler) by more than 15 %.Number of patients to be included in this study is 50.
• Study status:
  Planned

Research institutions and networks

Institutions

Hôpital Robert Debré

Study timelines

Date when funding contract was signed

Planned:11/12/2012

Study start date

Planned:01/01/2013

Data analysis start date

Planned:02/12/2013

Date of final study report

Planned:03/03/2014

Sources of funding

Other

More details on funding

Department Funding

Regulatory

• Was the study required by a regulatory body?:
  No