Risk of Gastric Insufflation Related to Facemask Ventilation Technique During Anaesthetic Induction, With or Without PEEP
1 other identifier
interventional
30
1 country
1
Brief Summary
Continuous positive pressure during anesthetic induction is today not routinely used partly a to the risk of gastric insufflation because of higher ventilatory pressures. However there are conflicting data with improvement of GERD symptoms in CPAP treated OSA patients. The investigators aim to compare the risk of gastric insufflation regarding mask ventilation technique, with or without positive end expiratory pressure. For measurements a High Resolution Impedance Manometry Catheter is used.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2014
CompletedFirst Posted
Study publicly available on registry
September 12, 2014
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedApril 5, 2016
April 1, 2016
7 months
August 13, 2014
April 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Level of inspiratory pressure for gastric insufflation
One hour
Secondary Outcomes (1)
Pressure changes in the esophagus related to ventilation technique.
One hour
Other Outcomes (1)
Pressure changes in the stomach after gastric insufflation
One hour
Study Arms (2)
Mask ventilation with PEEP
EXPERIMENTAL15 subjects will undergo anesthetic induction with application of PEEP of 10 cm H2O during mask ventilation.
Mask ventilation without PEEP
NO INTERVENTION15 subjects will undergo anesthetic induction without PEEP during mask ventilation.
Interventions
15 subjects will undergo anesthetic induction with an application of PEEP of 10 cm H2O during mask ventilation via a face mask. 15 subjects will undergo anesthetic induction without PEEP during mask ventilation via a face mask.
Eligibility Criteria
You may qualify if:
- Male or female age 18-40 years
- Signed and informed consent
- Subject will and is assumed to be able to follow protocol
You may not qualify if:
- Known gastro intestinal/heart/lung/kidney or neurological disease
- Use of drugs that interfere with esophageal motility
- Diabetes
- Pregnancy or breastfeeding
- BMI \>30
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Örebro University Hospital
Örebro, 70185, Sweden
Related Publications (1)
Cajander P, Edmark L, Ahlstrand R, Magnuson A, de Leon A. Effect of positive end-expiratory pressure on gastric insufflation during induction of anaesthesia when using pressure-controlled ventilation via a face mask: A randomised controlled trial. Eur J Anaesthesiol. 2019 Sep;36(9):625-632. doi: 10.1097/EJA.0000000000001016.
PMID: 31116114DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alex deLeon, MD, Phd
Region Örebro County
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
August 13, 2014
First Posted
September 12, 2014
Study Start
February 1, 2015
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
April 5, 2016
Record last verified: 2016-04