Clinical trial NCT01507623: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia
Keywords: NAPS
Hypoxia
Propofol
capnography
endoscopy
Sedation
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: The Ministry of Science, Technology and Innovation, Denmark
First posted: 2012-01-11
Enrollment: 591
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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in spite of this, hypoxia is experienced in 4,4% of patients receiving propofol during endoscopy at Gentofte Hospital (unpublished data).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


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

Primary outcomes:
measure: The number of hypoxic events
timeFrame: The sum of events registered during procedures (procedure duration is, depending on the type, 3 to 90 minutes)
Secondary outcomes:
measure: Actions taken against respiratory insufficiency
timeFrame: Registered during procedure(procedure duration is, depending on the type, 3 to 90 minutes)
measure: The duration of hypoxia
timeFrame: The sum of time with hypoxia registered during procedures (procedure duration is, depending on the type, 3 to 90 minutes)
measure: The level of hypoxia
timeFrame: The sum of events registered at each level during procedures (procedure duration is, depending on the type, 3 to 90 minutes)
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Gentofte University Hospital
Study officials:
affiliation: Herlev and Gentofte University Hospital, Denmark
name: Peter Vilmann, MD, Prof.
role: STUDY_DIRECTOR
affiliation: Gentofte University Hospital, Denmark
name: Charlotte Slagelse, Med. student
role: PRINCIPAL_INVESTIGATOR
References:
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.