Airway Effects of PEEP During Anesthesia Induction.

• Sponsor: Region Örebro County (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02920879
• Collaborator: (none)
• Enrollment: 120
• Arms: 4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Airway Management; Positive End Expiratory Pressure; Mask-ventilation; Anesthesia Induction	Procedure: PEEP-level, driving pressure	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Airway Effects of PEEP During Anesthesia Induction.
• Study Start Date: Oct 1, 2016
• Anticipated Primary Completion Date: Feb 1, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Time to open airway [20 minutes]

   Time to open airway depending on ventilatory settings

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Region Örebro County

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Region Örebro County
• ClinicalTrials.gov Identifier: NCT02920879
• Other Study ID Numbers: PC02
• First Posted: Sep 30, 2016
• Last Update Posted: Oct 3, 2016
• Last Verified: Sep 1, 2016

Study Results

No Results Posted as of Oct 3, 2016