Postoperative ComplicationsNCT05263154
Goal-directed Low Oxygen During Anesthesia
A study testing Goal directed low oxygen and High oxygen in people with Postoperative Complications, run by Umeå University at 1 site in Sweden.
Trial summary
The study aims at investigate whether low oxygen therapy during anesthesia improves oxygen partial pressure and lung function in the postoperative period after abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Goal directed low oxygen and High oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 28 Mar 2022to 31 Mar 2025
- 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
- Being scheduled for a major abdominal cancer surgery lasting for more than 2 hours.
- Having a condition within American Society of Anesthesia Class 1-3.
Who cannot join
- Being at risk for a difficult intubation during anesthesia in the form of Mallampati score 3-4, or having a previous documentation of difficult intubation.
- Decline participation
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
University hospital
Umeå, SE 901 85
Karl A Franklin, MD, Prof, +46907851256, karl.franklin@umu.se
Magnus Hultin, MD, Ass Prof, 460703505335, Magnus.hultin@umu.se
About this study
Official title: Goal-directed Low vs. High Oxygen Therapy During Anesthesia for Abdominal Surgery
The study aims at investigate whether low oxygen therapy during anesthesia improves oxygen partial pressure and lung function in the postoperative period after abdominal surgery. 200 patients scheduled for abdominal surgery will be randomized (1:1) to goal directed low oxygen concentration during and after anesthesia vs. fixed high oxygen concentration. Arterial oxygen partial pressure is the primary outcome and lung function a secondary explanatory outcome.
Read the detailed description
Postoperative hypoxia is a most common complication after major abdominal surgery. This study aims at investigate whether goal-directed low oxygen therapy during anesthesia improves oxygen partial pressure and lung function in the postoperative period after abdominal surgery.
200 adult patients scheduled for major abdominal cancer surgery lasting for more than 2 hours will be included after signed informed consent. Patients will then be randomized to either goal directed low oxygen or high oxygen during anesthesia and in the postoperative period.
Patients who are randomized to goal directed low oxygen will be given oxygen before the induction of anesthesia, with increasing fraction of inspired oxygen (FiO2) from 0.25 to 0.30 to 0.35 and so on. After intubation, the FiO2 is set to 0.25 to achieve a target saturation of 94-96%. Supplementary oxygen after surgery will be given with the same targets and with as little oxygen as necessary, Patients who are randomized to high oxygen will be given FiO2 of 1.0 before induction until end-tidal oxygen concentrations of 0.80 occur. The FiO2 will be reduced to 0.35 during anesthesia, followed by an increase in FiO2 to 0.80 during 5 minutes before extubating the patient, followed by FiO2 0.40 for at least thirty minutes after anesthesia. Oxgen will then be given at 3 liters a minute with a oxygen saturation goal of 98%.
Arterial blood gases, lung function measurements including diffusion capacity will be taken on the day before surgery. Blood gases will be taken during the first and second day after surgery and lung function tests during the second day after surgery. Blood gases and lung function will also be obtained at three months after surgery.
- Conditions
- Postoperative Complications
- Being tested
- Goal directed low oxygen, High oxygen
- Keywords
- postoperative hypoxia, abdominal surgery, randomized controlled trial
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal directed low oxygenOther
Oxygen is titrated until oxygen saturation is 100% in one-minute steps before the induction of anesthesia, with increasing fraction of inspired oxygen (FiO2) from 0.25 to 0.30 to 0.35 and so on. After intubation, the FiO2 is set to 0.25 to achieve a target saturation of 94-96%. Supplementary oxygen after surgery will be given with the same targets and with as little oxygen as necessary.
High oxygenOther
FiO2 1.0 before induction until end-tidal oxygen concentrations of 0.80 occur. The FiO2 will be reduced to 0.35 during anesthesia, followed by an increase in FiO2 to 0.80 during 5 minutes before extubating the patient, followed by FiO2 0.40 for at least thirty minutes after anesthesia. Oxgen will then be given at 3 liters a minute with a oxygen saturation goal of 98%
| Study group | Role | What they receive |
|---|---|---|
| Goal directed low oxygen | Experimental | Oxygen given at low concentrations following goals of oxygen saturation during and after anesthesia Receives: Other: Goal directed low oxygen |
| High oxygen | Active comparator | Oxygen given as traditionally including high concentrations Receives: Other: High oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in arterial oxygen partial pressure after surgery vs. before surgery
Oxygen partial pressure
Measured: 3 days
Secondary outcomes (9)
Mean change in diffusion capacity for carbon-monoxide after surgery vs. before surgery
Diffusion capacity
Measured: 3 days
Mean change in vital capacity after surgery vs. before surgery
Vital capacity
Measured: 3 days
Mean change in forced expiratory volume in one second after surgery vs. before surgery
Forced expiratory volume in one second
Measured: 3 days
Mean change in arterial carbon-dioxide partial pressure after surgery vs. before surgery
Carbon-dioxide partial pressure
Measured: 3 days
Mean change in arterial oxygen partial pressure after surgery vs. before surgery
Oxygen partial pressure
Measured: 3 months
Mean change in diffusion capacity for carbon-monoxide after surgery vs. before surgery
Diffusion capacity
Measured: 3 months
Mean change in vital capacity after surgery vs. before surgery
Vital capacity
Measured: 3 months
Mean change in forced expiratory volume in one second after surgery vs. before surgery
Forced expiratory volume in one second
Measured: 3 months
Mean change in arterial carbon-dioxide partial pressure after surgery vs. before surgery
Carbon-dioxide partial pressure
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start28 Mar 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- 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
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karl A Franklin, Umeå University
- Investigators
- Karl A Franklin, MD, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263154
- Sponsor's protocol ID
- 2021-02211
- Status last verified
- Aug 2023
- First submitted
- 20 Feb 2022
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Depends on what is allowed according to Swedish Ethical authority.
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal-directed Low vs. High Oxygen Therapy During Anesthesia for Abdominal Surgery
- ClinicalTrials.gov ID
- NCT05263154
- Acronym / sponsor ID
- 2021-02211
- Conditions
- Postoperative Complications
- Keywords
- postoperative hypoxia, abdominal surgery, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 2 Mar 2022 (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 aims at investigate whether low oxygen therapy during anesthesia improves oxygen partial pressure and lung function in the postoperative period after abdominal surgery. 200 patients scheduled for abdominal surgery will be randomized (1:1) to goal directed low oxygen concentration during and after anesthesia vs. fixed high oxygen concentration. Arterial oxygen partial pressure is the primary outcome and lung function a secondary explanatory outcome.
Detailed description
Postoperative hypoxia is a most common complication after major abdominal surgery. This study aims at investigate whether goal-directed low oxygen therapy during anesthesia improves oxygen partial pressure and lung function in the postoperative period after abdominal surgery.
200 adult patients scheduled for major abdominal cancer surgery lasting for more than 2 hours will be included after signed informed consent. Patients will then be randomized to either goal directed low oxygen or high oxygen during anesthesia and in the postoperative period.
Patients who are randomized to goal directed low oxygen will be given oxygen before the induction of anesthesia, with increasing fraction of inspired oxygen (FiO2) from 0.25 to 0.30 to 0.35 and so on. After intubation, the FiO2 is set to 0.25 to achieve a target saturation of 94-96%. Supplementary oxygen after surgery will be given with the same targets and with as little oxygen as necessary, Patients who are randomized to high oxygen will be given FiO2 of 1.0 before induction until end-tidal oxygen concentrations of 0.80 occur. The FiO2 will be reduced to 0.35 during anesthesia, followed by an increase in FiO2 to 0.80 during 5 minutes before extubating the patient, followed by FiO2 0.40 for at least thirty minutes after anesthesia. Oxgen will then be given at 3 liters a minute with a oxygen saturation goal of 98%.
Arterial blood gases, lung function measurements including diffusion capacity will be taken on the day before surgery. Blood gases will be taken during the first and second day after surgery and lung function tests during the second day after surgery. Blood gases and lung function will also be obtained at three months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Goal directed low oxygen | Experimental | Other: Goal directed low oxygenOxygen given at low concentrations following goals of oxygen saturation during and after anesthesia |
| High oxygen | Active comparator | Other: High oxygenOxygen given as traditionally including high concentrations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being scheduled for a major abdominal cancer surgery lasting for more than 2 hours.
- Having a condition within American Society of Anesthesia Class 1-3.
Key exclusion criteria (2 listed)
- Being at risk for a difficult intubation during anesthesia in the form of Mallampati score 3-4, or having a previous documentation of difficult intubation.
- Decline participation
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 |
|---|---|---|
| Goal directed low oxygenOxygen is titrated until oxygen saturation is 100% in one-minute steps before the induction of anesthesia, with increasing fraction of inspired oxygen (FiO2) from 0.25 to 0.30 to 0.35 and so on. After intubation, the FiO2 is set to 0.25 to achieve a target saturation of 94-96%. Supplementary oxygen after surgery will be given with the same targets and with as little oxygen as necessary. | Other | Goal directed low oxygen |
| High oxygenFiO2 1.0 before induction until end-tidal oxygen concentrations of 0.80 occur. The FiO2 will be reduced to 0.35 during anesthesia, followed by an increase in FiO2 to 0.80 during 5 minutes before extubating the patient, followed by FiO2 0.40 for at least thirty minutes after anesthesia. Oxgen will then be given at 3 liters a minute with a oxygen saturation goal of 98% | Other | High oxygen |
Primary outcome
Mean change in arterial oxygen partial pressure after surgery vs. before surgery
Time frame: 3 days
Oxygen partial pressure
9 secondary outcomes
Mean change in diffusion capacity for carbon-monoxide after surgery vs. before surgery
Time frame: 3 days
Mean change in vital capacity after surgery vs. before surgery
Time frame: 3 days
Mean change in forced expiratory volume in one second after surgery vs. before surgery
Time frame: 3 days
Mean change in arterial carbon-dioxide partial pressure after surgery vs. before surgery
Time frame: 3 days
Mean change in arterial oxygen partial pressure after surgery vs. before surgery
Time frame: 3 months
Mean change in diffusion capacity for carbon-monoxide after surgery vs. before surgery
Time frame: 3 months
Mean change in vital capacity after surgery vs. before surgery
Time frame: 3 months
Mean change in forced expiratory volume in one second after surgery vs. before surgery
Time frame: 3 months
Mean change in arterial carbon-dioxide partial pressure after surgery vs. before surgery
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Individual participant dataSharing planned: No. Depends on what is allowed according to Swedish Ethical authority.
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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.
Karl A Franklin, MD, PhD principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal directed low oxygen and High oxygen in people with Postoperative Complications, run by Umeå University 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 2 inclusion and 2 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 16 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karl A Franklin, MD, Prof (+46 907851256, karl.franklin@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in arterial oxygen partial pressure after surgery vs. before surgery (time frame: 3 days). 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 16 Aug 2023.