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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Goal directed low oxygen | Experimental | Oxygen given at low concentrations following goals of oxygen saturation during and after anesthesia |
|
| High oxygen | Active Comparator | Oxygen given as traditionally including high concentrations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goal directed low oxygen | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in arterial oxygen partial pressure after surgery vs. before surgery | Oxygen partial pressure | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in diffusion capacity for carbon-monoxide after surgery vs. before surgery | Diffusion capacity | 3 days |
| Mean change in vital capacity after surgery vs. before surgery | Vital capacity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karl A Franklin, MD, Prof | Contact | +46 907851256 | karl.franklin@umu.se |
| Name | Affiliation | Role |
|---|---|---|
| Karl A Franklin, MD, PhD | Umeå University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital | Recruiting | Umeå | SE 901 85 | Sweden |
Depends on what is allowed according to Swedish Ethical authority.
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C419216 | high-potential iron-sulfur protein oxygen oxidoreductase |
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Randomized controlled trial
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|
| High oxygen | Other | 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% |
|
| 3 days |
| Mean change in forced expiratory volume in one second after surgery vs. before surgery | Forced expiratory volume in one second | 3 days |
| Mean change in arterial carbon-dioxide partial pressure after surgery vs. before surgery | Carbon-dioxide partial pressure | 3 days |
| Mean change in arterial oxygen partial pressure after surgery vs. before surgery | Oxygen partial pressure | 3 months |
| Mean change in diffusion capacity for carbon-monoxide after surgery vs. before surgery | Diffusion capacity | 3 months |
| Mean change in vital capacity after surgery vs. before surgery | Vital capacity | 3 months |
| Mean change in forced expiratory volume in one second after surgery vs. before surgery | Forced expiratory volume in one second | 3 months |
| Mean change in arterial carbon-dioxide partial pressure after surgery vs. before surgery | Carbon-dioxide partial pressure | 3 months |