Value of Capnography During Nurse Administered Propofol Sedation (NAPS)
Primary Purpose
Hypoxia
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Capnography (Phillips MP20 monitor)
Sponsored by
About this trial
This is an interventional prevention trial for Hypoxia focused on measuring NAPS, Hypoxia, Propofol, capnography, endoscopy, Sedation
Eligibility 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
Sites / Locations
- Gentofte University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
With Capnograpy
No Capnography
Arm Description
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)
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)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT01507623
First Posted
November 24, 2011
Last Updated
January 10, 2012
Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
The Ministry of Science, Technology and Innovation, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT01507623
Brief Title
Value of Capnography During Nurse Administered Propofol Sedation (NAPS)
Official Title
The Role of Capnography in Endoscopy Patients Undergoing Nurse Administered Propofol Sedation (NAPS): A Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
The Ministry of Science, Technology and Innovation, Denmark
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia
Keywords
NAPS, Hypoxia, Propofol, capnography, endoscopy, Sedation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
591 (Actual)
8. Arms, Groups, and Interventions
Arm Title
With Capnograpy
Arm Type
Experimental
Arm Description
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)
Arm Title
No Capnography
Arm Type
No Intervention
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Capnography (Phillips MP20 monitor)
Other Intervention Name(s)
Capnography: Phillips MP20 monitor, Nasal cannulae: Smart CapnoLine GuardianTM
Intervention Description
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
Primary Outcome Measure Information:
Title
The number of hypoxic events
Description
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.
Time Frame
The sum of events registered during procedures (procedure duration is, depending on the type, 3 to 90 minutes)
Secondary Outcome Measure Information:
Title
Actions taken against respiratory insufficiency
Description
Whether more or less actions are taken against respiratory insufficiency with or without capnography in patients undergoing endoscopy with NAPS.
Time Frame
Registered during procedure(procedure duration is, depending on the type, 3 to 90 minutes)
Title
The duration of hypoxia
Description
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.
Time Frame
The sum of time with hypoxia registered during procedures (procedure duration is, depending on the type, 3 to 90 minutes)
Title
The level of hypoxia
Description
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.
Time Frame
The sum of events registered at each level during procedures (procedure duration is, depending on the type, 3 to 90 minutes)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Vilmann, MD, Prof.
Organizational Affiliation
Herlev and Gentofte University Hospital, Denmark
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Charlotte Slagelse, Med. student
Organizational Affiliation
Gentofte University Hospital, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gentofte University Hospital
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
23992025
Citation
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.
Results Reference
derived
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Value of Capnography During Nurse Administered Propofol Sedation (NAPS)
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