Decreased Lung ComplianceNCT03660306
Impact of OFA During LPV on Postoperative Oxygen Saturation
An observational study of Decreased Lung Compliance and Oxygen Requirement, run by AZ Sint-Jan AV at 1 site in Belgium.
Trial summary
Opioids used intra operative increase the amount of opioids needed post operative to control post operative pain. if opioids are given post operative, we assume that more atelectasis and hypoxia takes place even after lung protective ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decreased Lung Compliance, Oxygen Requirement
- What is being tested?
- opioid anesthesia and opioid free anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 64 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2018to 5 Nov 2019
- 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: Major surgery requiring intubation and mechanical ventilation.
Who may be able to join
- major surgery where intubation with mechanical ventilation is required
- obese patients with BMI > 35
Who cannot join
- spontaneous breathing during procedure
- allergic to any of the drugs used in both groups
- severe liver, renal, cardiac or pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study Evaluating the Impact of Opioid Free Anesthesia During Lung Protective Ventilation on Postoperative Oxygen Saturation.
Opioids used intra operative increase the amount of opioids needed post operative to control post operative pain. if opioids are given post operative, we assume that more atelectasis and hypoxia takes place even after lung protective ventilation. These postoperative lower oxygen saturations will require giving more frequent oxygen therapy.
Read the detailed description
This is an observational study where the attending anesthesiologist decides to use opioid free or opioid general anesthesia based on his/her expertise.
Every patient gets a lung protective ventilation and emergence from anesthesia using the principles set forward in the consensus meeting by Young C BJA 2019.
A lung recruitment followed by high PEEP is given when lung compliance decreases below 40 ML/cmH20. The lowest oxygen saturation without adding oxygen therapy is noted post extubation at moment of admission in PACU, after having given an opioid as analgesic and at moment of discharge from PACU..
If post operative satuation drops below 94% oxygen therapy is given and noted.
- Conditions
- Decreased Lung Compliance, Oxygen Requirement
- Being tested
- opioid anesthesia, opioid free anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
opioid anesthesiaProcedure or surgery
opioid anesthesia means using sufentanil during surgery
opioid free anesthesiaProcedure or surgery
opioid free anesthesia means giving no opioids during surgery
| Study group | Role | What they receive |
|---|---|---|
| opioid anesthesia | classical anesthesia using sufentanil to block sympathetic reactions during surgery. This decision is based on the anesthesiologist experience and not determined by the patient or procedure. Receives: Procedure: opioid anesthesia | |
| opioid free anesthesia | anesthesia using non opioids like dexmedetomidine, lidocaine, magnesium and ketamine to block sympathetic reactions during surgery. This decision is based on the anesthesiologist experience and not determined by the patient or procedure. Receives: Procedure: opioid free anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygen requirement post operative to maintain saturation above 94%
oxygen saturation
Measured: first 24 hours post operative
Secondary outcomes (2)
postoperative pain
postoperative pain measured by VAS score
Measured: first 24 hours post operative
postoperative opioid consumption
postoperative opioid consumption measured by morphine equivalents
Measured: first 24 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start1 Aug 2018
- Primary completion31 Oct 2019
- Study completion5 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decreased Lung ComplianceStudies 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
- 64 participants (actual)
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
- Marco Lanckneus, MD, Study director, AZ Sint-Jan AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660306
- Sponsor's protocol ID
- OS impact OFA on SAT d LPV
- Status last verified
- Dec 2019
- First submitted
- 4 Sep 2018
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study Evaluating the Impact of Opioid Free Anesthesia During Lung Protective Ventilation on Postoperative Oxygen Saturation.
- ClinicalTrials.gov ID
- NCT03660306
- Acronym / sponsor ID
- OS impact OFA on SAT d LPV
- Conditions
- Decreased Lung Compliance, Oxygen Requirement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 5 Nov 2019 (actual)
- First posted
- 6 Sep 2018 (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.
Opioids used intra operative increase the amount of opioids needed post operative to control post operative pain. if opioids are given post operative, we assume that more atelectasis and hypoxia takes place even after lung protective ventilation. These postoperative lower oxygen saturations will require giving more frequent oxygen therapy.
Detailed description
This is an observational study where the attending anesthesiologist decides to use opioid free or opioid general anesthesia based on his/her expertise.
Every patient gets a lung protective ventilation and emergence from anesthesia using the principles set forward in the consensus meeting by Young C BJA 2019.
A lung recruitment followed by high PEEP is given when lung compliance decreases below 40 ML/cmH20. The lowest oxygen saturation without adding oxygen therapy is noted post extubation at moment of admission in PACU, after having given an opioid as analgesic and at moment of discharge from PACU..
If post operative satuation drops below 94% oxygen therapy is given and noted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| opioid anesthesia | – | Procedure: opioid anesthesiaclassical anesthesia using sufentanil to block sympathetic reactions during surgery. This decision is based on the anesthesiologist experience and not determined by the patient or procedure. |
| opioid free anesthesia | – | Procedure: opioid free anesthesiaanesthesia using non opioids like dexmedetomidine, lidocaine, magnesium and ketamine to block sympathetic reactions during surgery. This decision is based on the anesthesiologist experience and not determined by the patient or procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major surgery requiring intubation and mechanical ventilation.
Key inclusion criteria (2 listed)
- major surgery where intubation with mechanical ventilation is required
- obese patients with BMI > 35
Key exclusion criteria (3 listed)
- spontaneous breathing during procedure
- allergic to any of the drugs used in both groups
- severe liver, renal, cardiac or pulmonary disease
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 |
|---|---|---|
| opioid anesthesiaopioid anesthesia means using sufentanil during surgery | Procedure or surgery | opioid anesthesia |
| opioid free anesthesiaopioid free anesthesia means giving no opioids during surgery | Procedure or surgery | opioid free anesthesia |
Primary outcome
oxygen requirement post operative to maintain saturation above 94%
Time frame: first 24 hours post operative
oxygen saturation
2 secondary outcomes
postoperative pain
Time frame: first 24 hours post operative
postoperative opioid consumption
Time frame: first 24 hours post operative
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 3 Dec 2019.
- Individual participant dataSharing planned: No
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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.
Marco Lanckneus, MD study director
AZ Sint-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 Decreased Lung Compliance and Oxygen Requirement, 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 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: finished, as of the sponsor's last update on 3 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?
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?
oxygen requirement post operative to maintain saturation above 94% (time frame: first 24 hours post operative). 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 Dec 2019.