Airway ManagementNCT02920879
Airway Effects of PEEP During Anesthesia Induction.
A study testing PEEP-level, driving pressure in people with Airway Management and Positive End Expiratory Pressure, run by Region Örebro County.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Airway Management, Positive End Expiratory Pressure, Mask-ventilation
- What is being tested?
- PEEP-level, driving pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18- ≤ 65 years male or female.
- Elective surgery under general anesthesia
- ASA-classification 1-3
- Signed and dated informed consent
Who cannot join
- BMI > 30
- Predicted difficult mask-ventilation
- Known hiatus hernia or GERD
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Airway Management, Positive End Expiratory Pressure, Mask-ventilation, Anesthesia Induction
- Being tested
- PEEP-level, driving pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP-level, driving pressureProcedure or surgery
Different levels of PEEP and different levels of driving pressures during mask-ventilation at anesthesia induction.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Procedure: PEEP-level, driving pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to open airway
Time to open airway depending on ventilatory settings
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920879
- Sponsor's protocol ID
- PC02
- Status last verified
- Sep 2016
- First submitted
- 28 Sep 2016
- Last updated
- 3 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Effects of PEEP During Anesthesia Induction.
- ClinicalTrials.gov ID
- NCT02920879
- Acronym / sponsor ID
- PC02
- Conditions
- Airway Management, Positive End Expiratory Pressure, Mask-ventilation, Anesthesia Induction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Feb 2017 (estimated)
- First posted
- 30 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0 CPAP/ 0 PEEP, driving pressure 10 | Other | Procedure: PEEP-level, driving pressurePatients 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 |
| 0 CPAP/ 0 PEEP driving pressure 20 | Other | Procedure: PEEP-level, driving pressurePatients 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 |
| 10 CPAP / 10 PEEP, driving pressure 10 | Other | Procedure: PEEP-level, driving pressurePatients 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 |
| 10 CPAP/ 0 PEEP, driving pressure 10 | Other | Procedure: PEEP-level, driving pressurePatients 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18- ≤ 65 years male or female.
- Elective surgery under general anesthesia
- ASA-classification 1-3
- Signed and dated informed consent
Key exclusion criteria (3 listed)
- BMI > 30
- Predicted difficult mask-ventilation
- Known hiatus hernia or GERD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEEP-level, driving pressureDifferent levels of PEEP and different levels of driving pressures during mask-ventilation at anesthesia induction. | Procedure or surgery | 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 |
Primary outcome
Time to open airway
Time frame: 20 minutes
Time to open airway depending on ventilatory settings
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP-level, driving pressure in people with Airway Management and Positive End Expiratory Pressure, run by Region Örebro County.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Per Cajander, MD (+46707173663, per.cajander@regionorebrolan.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to open airway (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2016.