NCT01287572

Brief Summary

Pediatric patients admitted to the intensive care unit and requiring conscious sedation for minor surgical procedures are at risk to hypoventilate and retain CO2. The rise in CO2 levels is not well described and unpredicted. In this study the investigators will monitor CO2 levels transcutaneously using SDMS (SenTec digital Monitoring System) a device recently approved for clinical use. The hypothesis is ventilation of patients undergoing conscious sedation is compromised and CO2 levels might rise significantly to levels that potentially can effect hemodynamics. In order to avoid hemodynamic changes proper and routine monitoring is recommended.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

January 24, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

February 1, 2011

Status Verified

January 1, 2011

Enrollment Period

1 year

First QC Date

January 24, 2011

Last Update Submit

January 31, 2011

Conditions

Conscious Sedation

Keywords

TcCO2sedationprocedurePICU

Outcome Measures

Primary Outcomes (1)

  • TcCO2 level

    Transcutaneous measurement of patients undergoing conscious sedation

    One year

Study Arms (1)

Conscious sedation group

Pediatric patients 0 to 18 years requiring conscious sedation for procedures done in the pediatric ICU excluding burned patients or patients with severe eczema or other skin disease.

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pediatric patirnts 0- 18 years admitted to the pediatric intensive care unit and undergoing minor procedures

You may qualify if:

  • pediatric patirnts 0- 18 years admitted to the pediatric intensive care unit
  • patients requiring minor surgical procedures (e.g. bronchoscopy, central venous line placement, lumbar puncture, intracranial pressure monitoring device insertion)

You may not qualify if:

  • skin disease
  • burns to thorax

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Study Officials

  • Yakov Sivan, MD

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

  • Efraim Sadot, MD

    Tel-Aviv Sourasky Medical Center

    STUDY DIRECTOR

Central Study Contacts

Efraim Sadot, MD

CONTACT

+97236974612efraims@tasmac.health.gov.il

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 24, 2011

First Posted

February 1, 2011

Study Start

February 1, 2011

Primary Completion

February 1, 2012

Study Completion

August 1, 2012

Last Updated

February 1, 2011

Record last verified: 2011-01

Locations

IL(1)