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NCT02920879 Clinical Trial

Airway Effects of PEEP During Anesthesia Induction.

Airway Management Clinical Trial

Official title:
Airway Effects of PEEP During Anesthesia Induction.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02920879
Other study ID # PC02
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 28, 2016
Last updated September 30, 2016
Start date October 2016

Study information
Verified date September 2016
Source Region Örebro County
Contact Per Cajander, MD
Phone +46707173663
Email per.cajander@regionorebrolan.se
Is FDA regulated No
Health authority Sweden: Regional Ethical Review BoardSweden: The National Board of Health and Welfare
Study type Interventional

Clinical Trial Summary

This study investigates airway effects of PEEP during maskventilation at anesthesia induction. Four patient groups will be ventilated with different PEEP and driving pressures to evaluate time to open airway after start of positive pressure maskventilation during anesthesia induction.

Description:

The use of continuous positive pressure (CPAP/PEEP) during pre-oxygenation and mask-ventilation in patients undergoing anesthesia induction is increasing. Continuous positive pressures have several respiratory benefits with well-documented data on both spontaneously breathing patients and intubated patients. However the effects of PEEP on anesthetized patients during mask-ventilation is poorly investigated. In a previous trial the that the investigators conducted, a PEEP-level of 10 cmH2O during mask ventilation after anesthesia induction surprisingly delayed time to alveolar ventilation compared to ZEEP. In order to investigate this phenomenon, four groups of patients will be compared during preoxygenation and mask ventilation after anesthesia induction.

Each group consisting of 30 patients will be pre-oxygenated and mask ventilated with different CPAP/PEEP levels and different driving pressures. Time to open airway is measured as number of respiratory cycles until detection of CO2 on the capnograph.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 120
Est. completion date
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

1. = 18- = 65 years male or female.

2. Elective surgery under general anesthesia

3. ASA-classification 1-3

4. Signed and dated informed consent

Exclusion Criteria:

1. BMI > 30

2. Predicted difficult mask-ventilation

3. Known hiatus hernia or GERD

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• PEEP-level, driving pressure
Different levels of PEEP and different levels of driving pressures during mask-ventilation at anesthesia induction.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Region Örebro County

Outcome
Type Measure Description Time frame Safety issue
Primary Time to open airway Time to open airway depending on ventilatory settings 20 minutes No
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