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HypoxiaNCT01507623

Value of Capnography During Nurse Administered Propofol Sedation (NAPS)

A study testing Capnography (Phillips MP20 monitor) in people with Hypoxia, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Any age
Conditions the study is for
Hypoxia
What is being tested?
Capnography (Phillips MP20 monitor)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
591 participants
Where
1 siteDenmark
Study dates
Sep 2010to Mar 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 11Show fewer
  • acute gastrointestinal bleeding
  • subileus
  • ventricular retention
  • severe COLD ((30% ≤ FEV1 <50%)
  • failed data collection

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Gentofte University Hospital

    Hellerup, 2900

Other trials in Denmark

About this study

Official title: 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.

Conditions
Hypoxia
Being tested
Capnography (Phillips MP20 monitor)
Keywords
NAPS, Hypoxia, Propofol, capnography, endoscopy, Sedation
Medical subject headings
Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Capnography (Phillips MP20 monitor)Device

    Also called Capnography: Phillips MP20 monitor, Nasal cannulae: Smart CapnoLine GuardianTM

    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

Study groups in NCT01507623
Study groupRoleWhat they receive
With CapnograpyExperimentalIntervention 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)
Receives: Device: Capnography (Phillips MP20 monitor)
No CapnographyNo interventionControl 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of hypoxic events

    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.

    Measured: The sum of events registered during procedures (procedure duration is, depending on the type, 3 to 90 minutes)

Secondary outcomes (3)

  1. Actions taken against respiratory insufficiency

    Whether more or less actions are taken against respiratory insufficiency with or without capnography in patients undergoing endoscopy with NAPS.

    Measured: Registered during procedure(procedure duration is, depending on the type, 3 to 90 minutes)

  2. The duration of hypoxia

    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.

    Measured: The sum of time with hypoxia registered during procedures (procedure duration is, depending on the type, 3 to 90 minutes)

  3. The level of hypoxia

    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.

    Measured: The sum of events registered at each level during procedures (procedure duration is, depending on the type, 3 to 90 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2012 (estimated)
  2. Study startSep 2010
  3. Primary completionFeb 2011
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
591 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01507623
Sponsor's protocol ID
NAPS_CAPNOGRAPHY1
Status last verified
Jan 2012
First submitted
24 Nov 2011
Last updated
11 Jan 2012
Results posted
No
Data monitoring committee
No

Publications

  • Slagelse C, Vilmann P, Hornslet P, Jorgensen HL, Horsted TI. The role of capnography in endoscopy patients undergoing nurse-administered propofol sedation: a randomized study. Scand J Gastroenterol. 2013 Oct;48(10):1222-30. doi: 10.3109/00365521.2013.830327. Epub 2013 Sep 2.

    PubMed 23992025

Questions about this trial

What is this clinical trial studying?

A study testing Capnography (Phillips MP20 monitor) in people with Hypoxia, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01507623, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2012; AzTrials last refreshed its copy on 7 Nov 2026.

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