Efficiency of Ventilation During Conscious Sedation in the Pediatric Intensive Care Unit

January 31, 2011 updated by: Tel-Aviv Sourasky Medical Center

Efficiency of Ventilation During Conscious Sedation of Pediatric Patients Undergoing Minor Procedures in the Pediatric Intensive Care Unit

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • skin disease
  • burns to thorax

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TcCO2 level
Time Frame: One year
Transcutaneous measurement of patients undergoing conscious sedation
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Investigators

  • Principal Investigator: Yakov Sivan, MD, Tel-Aviv Sourasky Medical Center
  • Study Director: Efraim Sadot, MD, Tel-Aviv Sourasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

February 1, 2012

Study Completion (Anticipated)

August 1, 2012

Study Registration Dates

First Submitted

January 24, 2011

First Submitted That Met QC Criteria

January 31, 2011

First Posted (Estimate)

February 1, 2011

Study Record Updates

Last Update Posted (Estimate)

February 1, 2011

Last Update Submitted That Met QC Criteria

January 31, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TASMC-10-YS-319-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Conscious Sedation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe