## Protocol Section
### Identification Module
**NCT ID:** NCT02920879

**Brief Title:** Airway Effects of PEEP During Anesthesia Induction.

**Official Title:** Airway Effects of PEEP During Anesthesia Induction.

#### Organization Study ID Info
**ID:** PC02
#### Organization
**Class:** OTHER
**Full Name:** Region Örebro County
### Status Module
#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2016-10-03

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-09-30

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2017-02

**Type:** ESTIMATED

#### Start Date
**Date:** 2016-10

**Status Verified Date:** 2016-09

#### Study First Post Date
**Date:** 2016-09-30
**Type:** ESTIMATED
**Study First Submit Date:** 2016-09-28
**Study First Submit QC Date:** 2016-09-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Region Örebro County

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Airway Management

- Positive End Expiratory Pressure

- Mask-ventilation

- Anesthesia Induction

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

- Procedure: PEEP-level, driving pressure

**Label:** 0 CPAP/ 0 PEEP, driving pressure 10

**Type:** OTHER

#### Arm Group 2

**Description:** 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

**Intervention Names:**

- Procedure: PEEP-level, driving pressure

**Label:** 0 CPAP/ 0 PEEP driving pressure 20

**Type:** OTHER

#### Arm Group 3

**Description:** 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

**Intervention Names:**

- Procedure: PEEP-level, driving pressure

**Label:** 10 CPAP / 10 PEEP, driving pressure 10

**Type:** OTHER

#### Arm Group 4

**Description:** 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

**Intervention Names:**

- Procedure: PEEP-level, driving pressure

**Label:** 10 CPAP/ 0 PEEP, driving pressure 10

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 0 CPAP/ 0 PEEP driving pressure 20

- 0 CPAP/ 0 PEEP, driving pressure 10

- 10 CPAP / 10 PEEP, driving pressure 10

- 10 CPAP/ 0 PEEP, driving pressure 10

**Description:** Different levels of PEEP and different levels of driving pressures during mask-ventilation at anesthesia induction.

**Name:** PEEP-level, driving pressure

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Time to open airway depending on ventilatory settings

**Measure:** Time to open airway

**Time Frame:** 20 minutes

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** per.cajander@regionorebrolan.se

**Name:** Per Cajander, MD

**Phone:** +46707173663

**Role:** CONTACT

**Contact 2:**

**Email:** johanna.savilampi@regionorebrolan.se

**Name:** Johanna Savilampi, PhD

**Phone:** +46706315154

**Role:** CONTACT

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
