Oxygen SaturationNCT04192305
Impact of LPV During OFA on Postoperative Oxygen Saturation.
An observational study of Oxygen Saturation, run by AZ Sint-Jan AV at 1 site in Belgium.
Trial summary
Observational study comparing patients with lung protective ventilation (LPV) following the consensus guidelines by Young C with patients getting routine lung ventilation, both during opioid free anesthesia (OFA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oxygen Saturation
- What is being tested?
- LPV and routine LV
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2019to Dec 2021
- Phase
- Observational
- 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
Study population: bariatric surgery is performed in obese patients with BMI > 35
Who may be able to join
- bariatric surgery
- morbid obesity ( BMI > 35)
Who cannot join
- patients with pre existing severe cardio-pulmonary diseases having oxygen saturation without oxygen below 94%.
Trial locations and contacts
1 site in 1 country.
Mulier contact
About this study
Official title: Observational Study Evaluating the Impact of Lung Protective Ventilation (LPV) During Opioid Free Anesthesia (OFA) on Postoperative Oxygen Saturation.
Observational study comparing patients with lung protective ventilation (LPV) following the consensus guidelines by Young C with patients getting routine lung ventilation, both during opioid free anesthesia (OFA).
Read the detailed description
The paper by C Young et al describes the essential steps in protecting the lungs and preventing post operative pulmonary complications (PPC) like alveolar collapse.
Alveolar collapse can be measured by oxygen saturation drop when no oxygen therapy is given, when full neuromuscular block (NMB) reversal and no opioid is given intra and postoperative.
LPV means:
tidal volume of 6 ml/kg, inspiratory-expiratory (I/E) ratio of 1/1, positive end expiratory pressure (PEEP) minimum 5 cmH20 and higher during laparoscopy in obese patients, Inspiratory oxygen concentration (FIO2) max 80% during induction and max 40 % during maintenance and extubation. Extubation in an awake, full NMB reversed patient getting no opioids while giving continuous positive airway pressure (CPAP) during withdrawal of the tube. Lung recruitment maneuver (LRM) when lung compliance decreases below 40 milliliter per centimeter water. (ml/cmH2O)
- Conditions
- Oxygen Saturation
- Being tested
- LPV, routine LV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LPVProcedure or surgery
LPV means tidal volume of 6 ml/kg, inspiratory-expiratory (I/E) ratio of 1/1, positive end expiratory pressure (PEEP) minimum 5 cmH20 and higher during laparoscopy in obese patients, Inspiratory oxygen concentration (FIO2) 40 % during maintenance and extubation while also giving CPAP. Lung recruitment maneuver (LRM) when lung compliance decreases below 40 ml/cmH2O.
routine LVProcedure or surgery
Give volume en frequency as required by end tidal carbon dioxide, PEEP and LRM only when saturation drops intra operative, no requirement to use low FIO2 and CPAP during extubation.
| Study group | Role | What they receive |
|---|---|---|
| lung protective ventilation (LPV) | lung protective ventilation low tidal volume, minimum PEEP and higher PEEP and lung recruitment based on total lung compliance, low inspiratory oxygen concentration and CPAP during extubation without prior suctioning inside the endotracheal tube. Receives: Procedure: LPV | |
| routine lung ventilation (LV) | ventilation and adapting PEEP, LRM and oxygen only when saturation drops. Receives: Procedure: routine LV |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative oxygen saturation
saturation is continuously measured in the post anesthetic area without giving oxygen until sat drops below 94%.
Measured: up to maximum 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start1 Dec 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen SaturationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Mulier, AZ Sint-Jan AV
- Investigators
- Jan Paul Mulier, Principal investigator, AZSint Jan AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192305
- Sponsor's protocol ID
- OS impact LPV on SAT d OFA
- Status last verified
- Dec 2019
- First submitted
- 2 Dec 2019
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study Evaluating the Impact of Lung Protective Ventilation (LPV) During Opioid Free Anesthesia (OFA) on Postoperative Oxygen Saturation.
- ClinicalTrials.gov ID
- NCT04192305
- Acronym / sponsor ID
- OS impact LPV on SAT d OFA
- Conditions
- Oxygen Saturation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 10 Dec 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.
Observational study comparing patients with lung protective ventilation (LPV) following the consensus guidelines by Young C with patients getting routine lung ventilation, both during opioid free anesthesia (OFA).
Detailed description
The paper by C Young et al describes the essential steps in protecting the lungs and preventing post operative pulmonary complications (PPC) like alveolar collapse.
Alveolar collapse can be measured by oxygen saturation drop when no oxygen therapy is given, when full neuromuscular block (NMB) reversal and no opioid is given intra and postoperative.
LPV means:
tidal volume of 6 ml/kg, inspiratory-expiratory (I/E) ratio of 1/1, positive end expiratory pressure (PEEP) minimum 5 cmH20 and higher during laparoscopy in obese patients, Inspiratory oxygen concentration (FIO2) max 80% during induction and max 40 % during maintenance and extubation. Extubation in an awake, full NMB reversed patient getting no opioids while giving continuous positive airway pressure (CPAP) during withdrawal of the tube. Lung recruitment maneuver (LRM) when lung compliance decreases below 40 milliliter per centimeter water. (ml/cmH2O)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lung protective ventilation (LPV) | – | Procedure: LPVlung protective ventilation low tidal volume, minimum PEEP and higher PEEP and lung recruitment based on total lung compliance, low inspiratory oxygen concentration and CPAP during extubation without prior suctioning inside the endotracheal tube. |
| routine lung ventilation (LV) | – | Procedure: routine LVventilation and adapting PEEP, LRM and oxygen only when saturation drops. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- bariatric surgery is performed in obese patients with BMI > 35
Key inclusion criteria (2 listed)
- bariatric surgery
- morbid obesity ( BMI > 35)
Key exclusion criteria (1 listed)
- patients with pre existing severe cardio-pulmonary diseases having oxygen saturation without oxygen below 94%.
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 |
|---|---|---|
| LPVLPV means tidal volume of 6 ml/kg, inspiratory-expiratory (I/E) ratio of 1/1, positive end expiratory pressure (PEEP) minimum 5 cmH20 and higher during laparoscopy in obese patients, Inspiratory oxygen concentration (FIO2) 40 % during maintenance and extubation while also giving CPAP. Lung recruitment maneuver (LRM) when lung compliance decreases below 40 ml/cmH2O. | Procedure or surgery | lung protective ventilation (LPV) |
| routine LVGive volume en frequency as required by end tidal carbon dioxide, PEEP and LRM only when saturation drops intra operative, no requirement to use low FIO2 and CPAP during extubation. | Procedure or surgery | routine lung ventilation (LV) |
Primary outcome
postoperative oxygen saturation
Time frame: up to maximum 4 hours
saturation is continuously measured in the post anesthetic area without giving oxygen until sat drops below 94%.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
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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.
Mulier contact
Jan Paul Mulier principal investigator
AZSint Jan AV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxygen Saturation, run by AZ Sint-Jan AV at 1 site in Belgium.
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 2 inclusion and 1 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 10 Dec 2019. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Paul Mulier (+32486729203, jan.mulier@azsintjan.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative oxygen saturation (time frame: up to maximum 4 hours). 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 10 Dec 2019.