NCT02920879

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Last Updated

October 3, 2016

Status Verified

September 1, 2016

Enrollment Period

4 months

First QC Date

September 28, 2016

Last Update Submit

September 30, 2016

Conditions

Airway ManagementPositive End Expiratory PressureMask-ventilationAnesthesia Induction

Outcome Measures

Primary Outcomes (1)

  • Time to open airway

    Time to open airway depending on ventilatory settings

    20 minutes

Study Arms (4)

0 CPAP/ 0 PEEP, driving pressure 10

OTHER

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

0 CPAP/ 0 PEEP driving pressure 20

OTHER

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

10 CPAP / 10 PEEP, driving pressure 10

OTHER

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

10 CPAP/ 0 PEEP, driving pressure 10

OTHER

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

Interventions

PEEP-level, driving pressurePROCEDURE

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

0 CPAP/ 0 PEEP driving pressure 200 CPAP/ 0 PEEP, driving pressure 1010 CPAP / 10 PEEP, driving pressure 1010 CPAP/ 0 PEEP, driving pressure 10

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18- ≤ 65 years male or female.
  • Elective surgery under general anesthesia
  • ASA-classification 1-3
  • Signed and dated informed consent

You may not qualify if:

  • BMI \> 30
  • Predicted difficult mask-ventilation
  • Known hiatus hernia or GERD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Per Cajander, MD

CONTACT

+46707173663per.cajander@regionorebrolan.se

Johanna Savilampi, PhD

CONTACT

+46706315154johanna.savilampi@regionorebrolan.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2016

First Posted

September 30, 2016

Study Start

October 1, 2016

Primary Completion

February 1, 2017

Last Updated

October 3, 2016

Record last verified: 2016-09