Value of Capnography During Nurse Administered Propofol Sedation (NAPS)

This study has been completed.
Sponsor:
Collaborator:
The Ministry of Science, Technology and Innovation, Denmark
Information provided by (Responsible Party):
Charlotte Slagelse, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01507623
First received: November 24, 2011
Last updated: January 10, 2012
Last verified: January 2012
  Purpose

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in spite of this, hypoxia is experienced in 4,4% of patients receiving propofol during endoscopy at Gentofte Hospital (unpublished data).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.


Condition Intervention
Hypoxia
Device: Capnography (Phillips MP20 monitor)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Role of Capnography in Endoscopy Patients Undergoing Nurse Administered Propofol Sedation (NAPS): A Randomized Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Actions taken against respiratory insufficiency [ Time Frame: Registered during procedure(procedure duration is, depending on the type, 3 to 90 minutes) ] [ Designated as safety issue: Yes ]
    Whether more or less actions are taken against respiratory insufficiency with or without capnography in patients undergoing endoscopy with NAPS.

  • 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) ] [ Designated as safety issue: Yes ]
    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 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) ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 591
Study Start Date: September 2010
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507623

Locations
Denmark
Gentofte University Hospital
Hellerup, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
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
  More Information

No publications provided by University Hospital, Gentofte, Copenhagen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Charlotte Slagelse, Medical Student, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01507623     History of Changes
Other Study ID Numbers: NAPS_CAPNOGRAPHY1
Study First Received: November 24, 2011
Last Updated: January 10, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University Hospital, Gentofte, Copenhagen:
NAPS
Hypoxia
Propofol
capnography
endoscopy
Sedation

Additional relevant MeSH terms:
Anoxia
Signs and Symptoms, Respiratory
Signs and Symptoms
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on August 28, 2014