General AnesthesiaNCT04271683
Safe Use of CPAP and PEEP During Induction of General Anesthesia
A study testing Manual ventilation without PEEP in people with General Anesthesia, run by Region Västmanland at 1 site in Sweden.
Trial summary
The study compares the safety of using pressure controlled ventilation with a positive end-expiratory pressure (PEEP) during induction of general anaesthesia immediately after apnoea to a standard method starting ventilation manually without PEEP immediately after apnoea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Manual ventilation without PEEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSweden
- Study dates
- 19 Oct 2021to 21 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Normal or overweight patients scheduled for day case surgery in general anesthesia.
- American Society of Anesthesiologists functional class I-III.
- Body Mass Index 18.5-30.
Who cannot join
- Increased risk of regurgitation of gastric content.
- Symptomatic asthma, COPD or heart failure.
- Peripheral oxygen saturation (SpO2) breathing air <94 %
- Anticipated difficult airway.
- Beard.
- Anatomical features making it difficult to keep a tight seal during maskventilation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safe Use of CPAP During Preoxygenation and PEEP After Apnoea During Induction of General Anesthesia
The study compares the safety of using pressure controlled ventilation with a positive end-expiratory pressure (PEEP) during induction of general anaesthesia immediately after apnoea to a standard method starting ventilation manually without PEEP immediately after apnoea.
Read the detailed description
Using a continuous positive pressure (CPAP) during preoxygenation, followed by pressure controlled ventilation with PEEP after apnoea during induction of general anesthesia, might offer several benefits but safety issues needs more investigation. This study compares the safety of using pressure controlled with PEEP during induction of general anesthesia immediately after apnoea to a standard method starting ventilation manually without PEEP immediately after apnoea.
- Conditions
- General Anesthesia
- Being tested
- Pressure controlled ventilation with PEEP, Manual ventilation without PEEP
- Keywords
- Positive end-expiratory pressure, Mechanical ventilation, Induction of anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure controlled ventilation with PEEPProcedure or surgery
The intervention consists of starting ventilation after apnoea during induction of general anesthesia with pressure controlled ventilation with PEEP instead of manually without PEEP.
Manual ventilation without PEEPProcedure or surgery
The intervention consists of starting ventilation after apnoea during induction of general anesthesia manually instead of with pressure controlled ventilation with PEEP.
| Study group | Role | What they receive |
|---|---|---|
| Pressure controlled ventilation with PEEP | Experimental | In this group, ventilation after apnoea during induction of general anesthesia starts with pressure controlled ventilation with PEEP. Receives: Procedure: Pressure controlled ventilation with PEEP |
| Manual ventilation without PEEP | Active comparator | In this group, ventilation after apnoea during induction of general anesthesia starts with manual ventilation without PEEP. Receives: Procedure: Manual ventilation without PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of breaths until return of CO2.
When starting ventilation after apnea the number of breaths given until the return of CO2 is at least 1.3 kPa at a respiratory frequency of 10 per minute.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start19 Oct 2021
- Primary completion20 Dec 2021
- Study completion21 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Västmanland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lennart Edmark, Region Västmanland
- Investigators
- Lennart Edmark, PhD, Principal investigator, Region Västmanland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271683
- Sponsor's protocol ID
- EPM 2019-05092
- Status last verified
- May 2023
- First submitted
- 13 Feb 2020
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Please email request to the study principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe Use of CPAP During Preoxygenation and PEEP After Apnoea During Induction of General Anesthesia
- ClinicalTrials.gov ID
- NCT04271683
- Acronym / sponsor ID
- EPM 2019-05092
- Conditions
- General Anesthesia
- Keywords
- Positive end-expiratory pressure, Mechanical ventilation, Induction of anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Region VästmanlandUniversity, hospital or other
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 17 Feb 2020 (actual)
- 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.
The study compares the safety of using pressure controlled ventilation with a positive end-expiratory pressure (PEEP) during induction of general anaesthesia immediately after apnoea to a standard method starting ventilation manually without PEEP immediately after apnoea.
Detailed description
Using a continuous positive pressure (CPAP) during preoxygenation, followed by pressure controlled ventilation with PEEP after apnoea during induction of general anesthesia, might offer several benefits but safety issues needs more investigation. This study compares the safety of using pressure controlled with PEEP during induction of general anesthesia immediately after apnoea to a standard method starting ventilation manually without PEEP immediately after apnoea.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pressure controlled ventilation with PEEP | Experimental | Procedure: Pressure controlled ventilation with PEEPIn this group, ventilation after apnoea during induction of general anesthesia starts with pressure controlled ventilation with PEEP. |
| Manual ventilation without PEEP | Active comparator | Procedure: Manual ventilation without PEEPIn this group, ventilation after apnoea during induction of general anesthesia starts with manual ventilation without PEEP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Normal or overweight patients scheduled for day case surgery in general anesthesia.
- American Society of Anesthesiologists functional class I-III.
- Body Mass Index 18.5-30.
Key exclusion criteria (6 listed)
- Increased risk of regurgitation of gastric content.
- Symptomatic asthma, COPD or heart failure.
- Peripheral oxygen saturation (SpO2) breathing air <94 %
- Anticipated difficult airway.
- Beard.
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 |
|---|---|---|
| Pressure controlled ventilation with PEEPThe intervention consists of starting ventilation after apnoea during induction of general anesthesia with pressure controlled ventilation with PEEP instead of manually without PEEP. | Procedure or surgery | Pressure controlled ventilation with PEEP |
| Manual ventilation without PEEPThe intervention consists of starting ventilation after apnoea during induction of general anesthesia manually instead of with pressure controlled ventilation with PEEP. | Procedure or surgery | Manual ventilation without PEEP |
Primary outcome
Number of breaths until return of CO2.
Time frame: 2 minutes
When starting ventilation after apnea the number of breaths given until the return of CO2 is at least 1.3 kPa at a respiratory frequency of 10 per minute.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
- Individual participant dataSharing planned: Yes. Please email request to the study principal investigator.
Related trials for General Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Not yet recruiting
Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
Airway Management
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
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.
Lennart Edmark, PhD principal investigator
Region Västmanland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual ventilation without PEEP in people with General Anesthesia, run by Region Västmanland at 1 site in Sweden.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of breaths until return of CO2. (time frame: 2 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 8 May 2023.