Value of Capnography During Nurse Administered Propofol Sedation (NAPS)

January 10, 2012 updated by: Charlotte Slagelse, University Hospital, Gentofte, Copenhagen

The Role of Capnography in Endoscopy Patients Undergoing Nurse Administered Propofol Sedation (NAPS): A Randomized Study

Propofol is widely used by anaesthesiologists for deep sedation and general anaesthesia. During recent years nurses trained in the use of low dose Propofol sedation (NAPS) during endoscopy have been introduced. The method has been implemented at the endoscopic unit at Gentofte hospital since 2008(1). Propofol has a respiratory depressive effect which may result in depressed oxygen saturation in the blood (hypoxia). Due to a short acting half life this is prevented in the majority of cases. However, in spite of this, hypoxia is experienced in 4,4% of patients receiving propofol during endoscopy at Gentofte Hospital (unpublished data). It is well known that hypoxia constitutes a late expression of reduced oxygen tension in peripheral tissues. Whether the addition of capnography to standard monitoring during NAPS may be of benefit is widely unknown. The aim of this study is to examine whether the additional use of capnography to standard monitoring during endoscopy may improve patient safety in patients undergoing low dose Propofol sedation by reducing the number, duration and level of hypoxic events. The trial is a randomized clinical prospective case-control study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

591

Phase

  • Not Applicable

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

  • Denmark
      • Hellerup, Denmark, 2900
        • Gentofte University Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged 18 or above
  • compliant with the criteria of NAPS.

Exclusion Criteria:

  • no signed written consent obtained
  • American Society of Anaesthesiologists (ASA) physical status classification > 3
  • sleep apnoea
  • allergy against soy, eggs and peanuts
  • body Mass Index (BMI) > 35 kg/m2
  • mallampati Score ≥ 4
  • acute gastrointestinal bleeding
  • subileus
  • ventricular retention
  • severe COLD ((30% ≤ FEV1 <50%)
  • failed data collection

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: With Capnograpy
Intervention group with the addition of capnography to standard monitoring (non-invasive blood pressure, pulse, pulse oximetry, clinical observation of respiration, electrocardiography (ECG) and respiratory frequency measured by the ECG)
Device: Capnography (Phillips MP20 monitor)

In the intervention group the NAPS nurse observed possible hypoxia and changes in capnography curves/values during the procedure and was instructed to decrease propofol and take actions against insufficient ventilation* if etCO2 ≥ 7kPa or ≤ 2 kPa for ≥ 1 minute, if respiratory frequency ≤ 8 or a loss of curve shape was registered.

*Suction, increase oxygen supply, tongue holder or nasal airway, bag-mask ventilation,paged anaesthesia Discontinued procedures

Other Names:
  • Capnography: Phillips MP20 monitor
  • Nasal cannulae: Smart CapnoLine GuardianTM
No Intervention: No Capnography
Control group without the addition of capnography to standard monitoring (non-invasive blood pressure, pulse, pulse oximetry, clinical observation of respiration, electrocardiography (ECG) and respiratory frequency measured by the ECG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of hypoxic events
Time Frame: The sum of events registered during procedures (procedure duration is, depending on the type, 3 to 90 minutes)
If the addition of capnography to standard monitoring can reduce the number of hypoxic events in patients undergoing endscopy with NAPS. A hypoxic event is defined as an observed oxygen saturation of less than 92% . Data is collected by a computer with intervals of 12 sec as the smallest possible.
The sum of events registered during procedures (procedure duration is, depending on the type, 3 to 90 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Actions taken against respiratory insufficiency
Time Frame: Registered during procedure(procedure duration is, depending on the type, 3 to 90 minutes)
Whether more or less actions are taken against respiratory insufficiency with or without capnography in patients undergoing endoscopy with NAPS.
Registered during procedure(procedure duration is, depending on the type, 3 to 90 minutes)
The duration of hypoxia
Time Frame: The sum of time with hypoxia registered during procedures (procedure duration is, depending on the type, 3 to 90 minutes)
The duration of hypoxia is measured as the sum of registrations(each registration represents 12 seconds) with an oxygen saturation of less than 92 percent. Data is collected by a computer with intervals of 12 sec as the smallest possible.
The sum of time with hypoxia registered during procedures (procedure duration is, depending on the type, 3 to 90 minutes)
The level of hypoxia
Time Frame: The sum of events registered at each level during procedures (procedure duration is, depending on the type, 3 to 90 minutes)

Saturation is registered every 12 seconds into a computer. Hypoxia (saturation <92%) was divided into three levels of hypoxia: 1. <92% - 90%,2. <90% - 88%, 3. <88%.

And the number of events in each group was summed up.
The sum of events registered at each level during procedures (procedure duration is, depending on the type, 3 to 90 minutes)

Collaborators and Investigators

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

Sponsor

University Hospital, Gentofte, Copenhagen

Collaborators

The Ministry of Science, Technology and Innovation, Denmark

Investigators

  • Study Director: Peter Vilmann, MD, Prof., Herlev and Gentofte University Hospital, Denmark
  • Principal Investigator: Charlotte Slagelse, Med. student, Gentofte University Hospital, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

November 24, 2011

First Submitted That Met QC Criteria

January 10, 2012

First Posted (Estimate)

January 11, 2012

Study Record Updates

Last Update Posted (Estimate)

January 11, 2012

Last Update Submitted That Met QC Criteria

January 10, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAPS_CAPNOGRAPHY1

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.

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