NCT01587157

Brief Summary

Capnography provides noninvasive monitoring of ventilation and can allow early recognition of altered respiration patterns and apnea. The aim of this prospective study was to compare the detection of apnea and the prediction of oxygen desaturation and hypoxemia by capnography versus clinical surveillance during procedural sedation for percutaneous transhepatic cholangiodrainage (PTCD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2010

Shorter than P25 for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 30, 2012

Completed
Last Updated

April 30, 2012

Status Verified

April 1, 2012

Enrollment Period

10 months

First QC Date

April 23, 2012

Last Update Submit

April 25, 2012

Conditions

ApneaHypoxemiaComplications

Outcome Measures

Primary Outcomes (1)

  • mean cumulative duration of detected apnea episodes per patient (capnographic vs. clinical surveillance)

Secondary Outcomes (2)

  • overall number of detected episodes of apnea

  • the occurrences of oxygen desaturation and hypoxemia

Study Arms (1)

capnography

EXPERIMENTAL
Procedure: capnography

Interventions

capnographyPROCEDURE
capnography

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age\>=18
  • Scheduled for PTCD with midazolam and propofol sedation

You may not qualify if:

  • age less than 18 years
  • ASA class V
  • allergy to narcotic drugs
  • pregnancy
  • pre-existing hypotension, bradycardia or hypoxemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum rechts der Isar

Munich, Bavaria, 81675, Germany

Location

MeSH Terms

Conditions

ApneaHypoxia

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2012

First Posted

April 30, 2012

Study Start

August 1, 2010

Primary Completion

June 1, 2011

Study Completion

August 1, 2011

Last Updated

April 30, 2012

Record last verified: 2012-04

Locations

DE(1)