Airway Effects of PEEP During Anesthesia Induction.

NCT ID: NCT02920879

Last Updated: 2016-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Brief Summary

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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

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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

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Airway Management Positive End Expiratory Pressure Mask-ventilation Anesthesia Induction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type OTHER

PEEP-level, driving pressure

Intervention Type PROCEDURE

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

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

Group Type OTHER

PEEP-level, driving pressure

Intervention Type PROCEDURE

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

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

Group Type OTHER

PEEP-level, driving pressure

Intervention Type PROCEDURE

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

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

Group Type OTHER

PEEP-level, driving pressure

Intervention Type PROCEDURE

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

Interventions

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PEEP-level, driving pressure

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Örebro County

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Per Cajander, MD

Role: CONTACT

+46707173663

Johanna Savilampi, PhD

Role: CONTACT

+46706315154

Other Identifiers

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PC02

Identifier Type: -

Identifier Source: org_study_id

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