NCT01638793

Brief Summary

The present study is a randomized, prospective, single-blinded study. Patients presenting for colonoscopy under sedation will be included according to the statistical sample size calculation. Patients will be randomized to either group 1- capnographic monitoring or group 2- oxygenic monitoring during Propofol-based sedation for colonoscopy. Episodes of Hypoxia are documented and compared in both groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
528

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

2 active sites

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

June 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 11, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

October 25, 2013

Status Verified

June 1, 2012

Enrollment Period

1.3 years

First QC Date

July 11, 2012

Last Update Submit

October 24, 2013

Conditions

Hypoxia

Outcome Measures

Primary Outcomes (1)

  • Hypoxia (SO2 <90%)

    Study objective is to evaluate if a reduction of hypoxic events (SO2 \<90% for ≥ 15 sec) can be obtained with capnographic monitoring as compared to standard monitoring of respiration with pulse-oxymetry in patients receiving colonoscopy under Propofol-based sedation

Secondary Outcomes (4)

  • Severe Hypoxia (SO2 <85%)

  • Time to hypoxia

  • Hypoxia in relation to sedation

  • Vegetative Symptoms

Study Arms (2)

Capnography

EXPERIMENTAL

Capnographic respiration monitoring

Device: Microcap (Oridion, Needham, MA, USA)

Pulse-Oxymetry

ACTIVE COMPARATOR

pulse-oxymetric respiration monitoring

Device: Smart Capno Line Plus O2 (Oridion, Needham, MA, USA)

Interventions

Microcap (Oridion, Needham, MA, USA)DEVICE
Capnography
Smart Capno Line Plus O2 (Oridion, Needham, MA, USA)DEVICE
Pulse-Oxymetry

Eligibility Criteria

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

You may qualify if:

  • Indication for colonoscopy
  • Patient wishing sedation during colonoscopy
  • ≥ 18 years of age
  • Signed informed consent form

You may not qualify if:

  • Diseases which preclude study accomplishment or put the patient at any risk (e.g. psychiatric diseases)
  • Non-contractually capable persons
  • Pregnancy
  • Lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Klinikum der J. W. Goethe-Universität

Frankfurt am Main, 60590, Germany

Location

Praxisklinik am Staedel

Frankfurt am Main, 60596, Germany

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mireen Friedrich-Rust, MD

    Klinikum der J. W. Goethe-Universität Frankfurt am Main

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 11, 2012

First Posted

July 12, 2012

Study Start

June 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

October 25, 2013

Record last verified: 2012-06

Locations

DE(2)