NCT00577369

Brief Summary

In this feasibility study we will collect blood from indwelling arterial catheters in up to 20 patients undergoing non-emergent surgery with desflurane anesthesia at Children's Hospital of Philadelphia. Desflurane levels will be determined by high pressure liquid chromatography (HPLC). Our eventual goal is to quantify fetal levels of desflurane in umbilical cord blood during fetal surgery. We propose a pilot study to assess the ability of our assay to measure desflurane in human blood.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 20, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

September 16, 2009

Status Verified

September 1, 2009

Enrollment Period

6 months

First QC Date

December 18, 2007

Last Update Submit

September 14, 2009

Conditions

Desflurane Levels

Keywords

arterial lineend-expiratory desflurane

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint will simply be the successful measurement of desflurane in human blood.

    During one operation.

Secondary Outcomes (1)

  • Secondary endpoints will include obtaining similar levels of desflurane across several patients who are have similar levels of end expiratory desflurane.

    During one operation.

Study Arms (1)

1

ACTIVE COMPARATOR

The subject's participation will take place over one surgical procedure. It will begin with the first blood collection and end with either the second blood draw or the end of the procedure.

Other: Desflurane Levels

Interventions

Desflurane LevelsOTHER

The subject's participation will take place over one surgical procedure. It will begin with the first blood collection and end with either the second blood draw or the end of the procedure.

1

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children between 1 and 18 years old
  • Weight \>10 kg
  • Scheduled for elective surgery
  • Patient will have an arterial catheter placed as routine care for the surgery
  • Informed consent (and assent if applicable)

You may not qualify if:

  • Desflurane not used as part of anesthetic
  • Preoperative hemoglobin less than 9 mg/dl
  • Any investigational drug use within 30 days prior to enrollment
  • Pregnant or lactating females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital Of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

  • Kha Tran, MD

    Children's Anesthesiology Associates, Ltd.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 18, 2007

First Posted

December 20, 2007

Study Start

December 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

September 16, 2009

Record last verified: 2009-09

Locations

US(1)