Airway Effects of PEEP During Anesthesia Induction.

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.

Study Overview

• Status: Unknown
• Conditions: Airway Management; Positive End Expiratory Pressure; Mask-ventilation; Anesthesia Induction
• Intervention / Treatment: Procedure: PEEP-level, driving pressure

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Per Cajander, MD; Phone Number: +46707173663; Email: per.cajander@regionorebrolan.se
• Study Contact Backup: Name: Johanna Savilampi, PhD; Phone Number: +46706315154; Email: johanna.savilampi@regionorebrolan.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 0 CPAP/ 0 PEEP, driving pressure 10; Patients will be preoxygenated with a CPAP-level of 0 cmH2O and after anesthesia induction, mask-ventilated with ZEEP and a driving pressure of 10 cmH2O./PEEP-level, driving pressure	Procedure: PEEP-level, driving pressure; Different levels of PEEP and different levels of driving pressures during mask-ventilation at anesthesia induction.
Other: 0 CPAP/ 0 PEEP driving pressure 20; Patients will be pre-oxygenated with a CPAP-level of 0 cmH2O and after anesthesia induction, mask-ventilated with ZEEP and a driving pressure of 20 cmH2O./PEEP-level, driving pressure	Procedure: PEEP-level, driving pressure; Different levels of PEEP and different levels of driving pressures during mask-ventilation at anesthesia induction.
Other: 10 CPAP / 10 PEEP, driving pressure 10; Patients will be pre-oxygenated with a CPAP-level of 10 cmH2O and after anesthesia induction, mask-ventilated with PEEP 10 cmH2O and a driving pressure of 10 cmH2O./PEEP-level, driving pressure	Procedure: PEEP-level, driving pressure; Different levels of PEEP and different levels of driving pressures during mask-ventilation at anesthesia induction.
Other: 10 CPAP/ 0 PEEP, driving pressure 10; Patients will be pre-oxygenated with a CPAP-level of 10 cmH2O and after anesthesia induction, mask-ventilated with ZEEP and a driving pressure of 10 cmH2O./PEEP-level, driving pressure	Procedure: PEEP-level, driving pressure; Different levels of PEEP and different levels of driving pressures during mask-ventilation at anesthesia induction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to open airway	Time to open airway depending on ventilatory settings	20 minutes

Collaborators and Investigators

• Sponsor: Region Örebro County

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): February 1, 2017
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: September 28, 2016
• First Submitted That Met QC Criteria: September 28, 2016
• First Posted (Estimate): September 30, 2016

Study Record Updates

• Last Update Posted (Estimate): October 3, 2016
• Last Update Submitted That Met QC Criteria: September 30, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: PC02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No