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NCT Number: NCT01507623

Value of Capnography During Nurse Administered Propofol Sedation (NAPS)

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in spite of this, hypoxia is experienced in 4,4% of patients receiving propofol during endoscopy at Gentofte Hospital (unpublished data).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

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Key information

Conditions

Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gentofte University Hospital

Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capnography (Phillips MP20 monitor)

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Collaborators

  • The Ministry of Science, Technology and Innovation, Denmark

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 11, 2012
Registry last updated
Jan 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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