Status:

COMPLETED

Capnography During Nurse Administered Propofol Sedation

Lead Sponsor:

UMC Utrecht

Collaborating Sponsors:

CASA, Leiden

Conditions:

Alveolar Hypoventilation Resulting in Hypoxemia

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief Summary

Rationale: The current standard of respiratory monitoring for patients during deep sedation is continuous pulse oximetry with visual assessment of the patient. Clinical research has demonstrated that ...

Detailed Description

1. INTRODUCTION AND RATIONALE Since sedation is increasingly administered by non-anesthesiologists, patient safety during sedation became of increased interest by the Joint Commission for Accreditatio...

Eligibility Criteria

Inclusion

  • Patients were considered for enrolment if they fulfil all of the following inclusion criteria: age 18 years or older, abortion procedures performed until 22 weeks of gestational age, American Society of Anaesthesiologists (ASA) classes I to II, and ability (mental competence) to give informed consent.

Exclusion

  • Exclusion criteria were inability to provide informed consent, history of allergic reactions to propofol, soybeans or egg proteins, American Society of Anaesthesiologists (ASA) classes III- V, sleep apnea syndrome, and seizure disorders.

Key Trial Info

Start Date :

April 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 1 2011

Estimated Enrollment :

440 Patients enrolled

Trial Details

Trial ID

NCT01220765

Start Date

April 1 2010

End Date

February 1 2011

Last Update

June 10 2011

Active Locations (1)

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CASA, Centre for Contraception, Sexuality and Abortion clinic,

Leiden, Netherlands, 2313 DH