OxygenationZAPPAIINCT04150276
Obesity, PEEP and Postoperative Oxygenation
A study testing ZEEP during awakening and PEEP during awakening in people with Oxygenation, run by Region Västmanland at 1 site in Sweden.
Trial summary
A study on overweight patients undergoing anesthesia for laparoscopic surgery. evaluation of positive end-expiratory pressure versus zero positive end-expiratory pressure during awakening on oxygenation in the early postoperative period. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Oxygenation
- What is being tested?
- ZEEP during awakening and PEEP during awakening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 3 Dec 2019to 25 Jan 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Obese patients scheduled for elective laparocopic surgery.
- American Society of Anesthesiologists functional class I-III
- Body Mass Index 35-50 kg/m2
Who cannot join
- Body Mass Index ≥50 kg/m2
- Peripheral oxygen saturation (SpO2) breathing air <94 %
- Symtomatic asthma, COPD or heart failure
- Ischemic heart disease
- Hemoglobin < 100g/l
- Smokers and ex-smokers that stopped smoking < 9 months ago
- Need for peroperative RM and PEEP higher than in study protocol, as indicated by SpO2 <92% despite the stipulated FiO2 0.30-0.35.
- Obstructive sleep apnea syndrome on home-CPAP
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dep. of Anaesthesia and Intensive Care
Västerås, Region Västmanland
About this study
Official title: Zero Positive End-expiratory Pressure Before Emergence Improves Postoperative Oxygenation in Obese Patients Undergoing Laparoscopic Surgery - a Randomized Clinical Trial
A study on overweight patients undergoing anesthesia for laparoscopic surgery.
- evaluation of positive end-expiratory pressure versus zero positive end-expiratory pressure during awakening on oxygenation in the early postoperative period.
Read the detailed description
Positive end-expiratory pressure (PEEP) is often used during mechanical ventilation to preserve end-expiratory lung volume. After emergence and extubation, this volume will diminish instantly. Some patients will have difficulties to restore functional residual capacity (FRC) during the early phase of recovery. If routine high FIO2 is being delivered together with maintained PEEP prior to extubation, several important prerequisites are established for the development of postoperative atelectasis. The investigators hypothesize that establishing zero positive end-expiratory pressure (ZEEP) immediately prior to emergence preoxygenation, will prevent gas with high oxygen concentration from entering dorso-basal areas of the lungs, and thereby diminishing postoperative atelectasis formation and improve oxygenation.
This randomized controlled study will study overweight patients undergoing general anesthesia for laparoscopic surgery. The patients in the two study groups will receive mechanical ventilation with identical settings, comprising low TV, PEEP, and no RM. Randomization will occur at the end of surgery, before awakening. The patients will be allocated to zero PEEP (ZEEP) or maintained PEEP during emergence preoxygenation and extubation. Importantly, the intervention group will have ZEEP established while still having low ETO2 levels, prior to any preoxygenation. Arterial blood gases will be collected before, during and after anaesthesia. Primary endpoint measure will be change in oxygenation from before awakening to after awakening.
- Conditions
- Oxygenation
- Being tested
- ZEEP during awakening, PEEP during awakening
- Keywords
- Oxygenation, Positive end-expiratory pressure, General anaesthesia, Obesity, Atelectasis, Mechanical ventilation
- Medical subject headings
- Obesity, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZEEP during awakeningProcedure or surgery
ZEEP will be established 2 min prior to the start of emergence preoxygenation and awakening.
PEEP during awakeningProcedure or surgery
PEEP will be maintained throughout emergence preoxygenation and awakening.
| Study group | Role | What they receive |
|---|---|---|
| ZEEP during awakening | Active comparator | ZEEP will be used during emergence preoxygenation and awakening. Receives: Procedure: ZEEP during awakening |
| PEEP during awakening | Active comparator | PEEP is maintained throughout emergence preoxygenation and awakening. Receives: Procedure: PEEP during awakening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in oxygenation
Arterial blood samples will be collected for measurement of arterial oxygen partial pressure.
Measured: Bloodgases will be obtained 5 minutes before the start of the awakening procedure and 30 minutes after awakening and extubation.
Secondary outcomes (1)
Need for postoperative supplemental oxygen
Number of patients and amount of oxygen needed in the respective group postoperatively.
Measured: First 3 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start3 Dec 2019
- Primary completion25 Jan 2023
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OxygenationStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Västmanland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erland Ostberg, Region Västmanland
- Investigators
- Erland Östberg, MD, PhD, Principal investigator, Region Västmanland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150276
- Sponsor's protocol ID
- Dnr 2019/04860
- Acronym
- ZAPPAII
- Status last verified
- Jan 2023
- First submitted
- 31 Oct 2019
- Last updated
- 26 Jan 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.
Publications
Ostberg E, Larsson A, Wagner P, Eriksson S, Edmark L. Positive end-expiratory pressure and emergence preoxygenation after bariatric surgery: effect on postoperative oxygenation: A randomised controlled trial. Eur J Anaesthesiol. 2025 Jan 1;42(1):54-63. doi: 10.1097/EJA.0000000000002071. Epub 2024 Oct 3.
PubMed 39325031
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zero Positive End-expiratory Pressure Before Emergence Improves Postoperative Oxygenation in Obese Patients Undergoing Laparoscopic Surgery - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04150276
- Acronym / sponsor ID
- ZAPPAII / Dnr 2019/04860
- Conditions
- Oxygenation
- Keywords
- Oxygenation, Positive end-expiratory pressure, General anaesthesia, Obesity, Atelectasis, Mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Region VästmanlandUniversity, hospital or other
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 4 Nov 2019 (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.
A study on overweight patients undergoing anesthesia for laparoscopic surgery.
- evaluation of positive end-expiratory pressure versus zero positive end-expiratory pressure during awakening on oxygenation in the early postoperative period.
Detailed description
Positive end-expiratory pressure (PEEP) is often used during mechanical ventilation to preserve end-expiratory lung volume. After emergence and extubation, this volume will diminish instantly. Some patients will have difficulties to restore functional residual capacity (FRC) during the early phase of recovery. If routine high FIO2 is being delivered together with maintained PEEP prior to extubation, several important prerequisites are established for the development of postoperative atelectasis. The investigators hypothesize that establishing zero positive end-expiratory pressure (ZEEP) immediately prior to emergence preoxygenation, will prevent gas with high oxygen concentration from entering dorso-basal areas of the lungs, and thereby diminishing postoperative atelectasis formation and improve oxygenation.
This randomized controlled study will study overweight patients undergoing general anesthesia for laparoscopic surgery. The patients in the two study groups will receive mechanical ventilation with identical settings, comprising low TV, PEEP, and no RM. Randomization will occur at the end of surgery, before awakening. The patients will be allocated to zero PEEP (ZEEP) or maintained PEEP during emergence preoxygenation and extubation. Importantly, the intervention group will have ZEEP established while still having low ETO2 levels, prior to any preoxygenation. Arterial blood gases will be collected before, during and after anaesthesia. Primary endpoint measure will be change in oxygenation from before awakening to after awakening.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZEEP during awakening | Active comparator | Procedure: ZEEP during awakeningZEEP will be used during emergence preoxygenation and awakening. |
| PEEP during awakening | Active comparator | Procedure: PEEP during awakeningPEEP is maintained throughout emergence preoxygenation and awakening. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Obese patients scheduled for elective laparocopic surgery.
- American Society of Anesthesiologists functional class I-III
- Body Mass Index 35-50 kg/m2
Key exclusion criteria (8 listed)
- Body Mass Index ≥50 kg/m2
- Peripheral oxygen saturation (SpO2) breathing air <94 %
- Symtomatic asthma, COPD or heart failure
- Ischemic heart disease
- Hemoglobin < 100g/l
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 |
|---|---|---|
| ZEEP during awakeningZEEP will be established 2 min prior to the start of emergence preoxygenation and awakening. | Procedure or surgery | ZEEP during awakening |
| PEEP during awakeningPEEP will be maintained throughout emergence preoxygenation and awakening. | Procedure or surgery | PEEP during awakening |
Primary outcome
Change in oxygenation
Time frame: Bloodgases will be obtained 5 minutes before the start of the awakening procedure and 30 minutes after awakening and extubation.
Arterial blood samples will be collected for measurement of arterial oxygen partial pressure.
1 secondary outcome
Need for postoperative supplemental oxygen
Time frame: First 3 hours postoperatively.
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 26 Jan 2023.
- Derived from this study: PubMed 39325031Ostberg E, Larsson A, Wagner P, Eriksson S, Edmark L. Positive end-expiratory pressure and emergence preoxygenation after bariatric surgery: effect on postoperative oxygenation: A randomised controlled trial. Eur J Anaesthesiol. 2025 Jan 1;42(1):54-63. doi: 10.1097/EJA.0000000000002071. Epub 2024 Oct 3.
- Individual participant dataSharing planned: Yes. Please email request to the study principal investigator.
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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.
Erland Östberg, MD, 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 ZEEP during awakening and PEEP during awakening in people with Oxygenation, 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 8 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 26 Jan 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?
Change in oxygenation (time frame: Bloodgases will be obtained 5 minutes before the start of the awakening procedure and 30 minutes after awakening and extubation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04150276, which also lists 1 linked publication.
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 26 Jan 2023.