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To evaluate the effect of 80% inspiratory oxygen fraction (FiO2) and 30% FiO2 on the incidence of pulmonary complications after pulmonary reexpansion following one-lung ventilation and 2-hour postoperative within the first 7 days after thoracic surgery, based on lung protective ventilation strategy.
Postoperative pulmonary complications (PPCs) account for the highest proportion (about 84%) among all the factors leading to death in thoracic surgery. High FiO2 was used in perioperative period. However, there is increasing evidence that high FiO2 in non-thoracic surgery can increase respiratory related adverse events and even mortality. The guideline also suggests that low FiO2 (30-50%) during surgery while ensuring moderate level of oxygenation would be more beneficial to the prognosis of patients. Whereas, the selection of oxygen concentration in thoracic surgery is still unclear, especially which oxygen concentration ventilation is more beneficial to reduce PPCs after pulmonary reexpansion. Strict randomized controlled clinical studies are urgently needed to verify the differences in the incidence of PPCs in patients with different oxygen concentration ventilation strategies. The study aim is to evaluate the effect of 80% FiO2 and 30% FiO2 on the incidence of pulmonary complications after pulmonary reexpansion following one-lung ventilation and 2-hour postoperative within the first 7 days after thoracic surgery, based on lung protective ventilation strategy, and to provide clinical basis for optimizing perioperative management of thoracic surgery and effectively reducing the occurrence of perioperative pulmonary complications
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Received low FiO2 | Experimental | Patients undergoing elective thoracic surgery were treated with 30% FiO2 after pulmonary reexpansion following one-lung ventilation and 2-hour postoperative. |
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| Received high FiO2 | Active Comparator | Patients undergoing elective thoracic surgery were treated with 80% FiO2 after pulmonary reexpansion following one-lung ventilation and 2-hour postoperative. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low FiO2 | Procedure | FiO2 was 100% in two-lung ventilation during anesthesia induction and one-lung ventilation stage intraoperative. FiO2 was 30% in two-lung ventilation after pulmonary reexpansion. During 2 hours after extubation, oxygen was administered through a non-reabsorption mask (high concentration oxygen mask; Intersurgical Ltd, Wokingham, UK) with a respiratory sac in the post anesthesia care unit (PACU), FiO2 was 30% (2L oxygen +14L air per minute). If the subjects who need to be admitted to the intensive care unit (ICU) fail to resuscitate the extubation within a short time after surgery due to their condition and require prolonged respiratory support, FiO2 should be adjusted to 30% 2 hours after admission to the ICU, and respiratory support according to the routine ventilation strategy of ICU should be provided 2 hours later. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of a composite of postoperative pulmonary complications (PPCs) within the first 7 postoperative days | The incidence of a composite of PPCs within the first 7 postoperative days evaluated by established criteria | 7 postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary diagnosis of PPCs | PPCs were defined by established criteria and included respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonitis | 7 postoperative days |
| Grading of PPCs |
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Inclusion Criteria:1. Elective thoracic surgery: lung surgery, esophageal surgery, mediastinal surgery, etc.; 2. One-lung ventilation: double lumen bronchial cannula or occluder is used for isolation of one lung; 3, American Society of Anesthesiology (ASA) grade I ~ III; 4, 18 years ≤ age < 80 years; 5. Estimated operation time ≥2 hours; 6. Agree to participate and sign the informed consent.
Exclusion Criteria:
6. Pregnant women; 7. Preoperative Hb<70g/L or haematocrit<30%.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Xiaojing, M.D. | Contact | +8613764152169 | yoyowxj@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wang Xiaojing, M.D. | Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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| high FiO2 | Procedure | FiO2 was 100% in two-lung ventilation during anesthesia induction and one-lung ventilation stage intraoperative. FiO2 was 80% in two-lung ventilation after pulmonary reexpansion. During 2 hours after extubation, oxygen was administered through a non-reabsorption mask (high concentration oxygen mask; Intersurgical Ltd, Wokingham, UK) with a respiratory sac in the post anesthesia care unit (PACU), FiO2 was 80% (14L oxygen +2L air per minute). If the subjects who need to be admitted to the intensive care unit (ICU) fail to resuscitate the extubation within a short time after surgery due to their condition and require prolonged respiratory support, FiO2 should be adjusted to 80% 2 hours after admission to the ICU, and respiratory support according to the routine ventilation strategy of ICU should be provided 2 hours later. |
|
Grading of PPCs evaluated by Clavien-Dindo classification |
| 7 postoperative days |
| Grading of surgical complications | The surgical complications were classified with the Clavien-Dindo classification from grade 0 (no complication) to grade V (death) | 30 postoperative days |
| Extubation time | The time from the end of surgery to extubation was calculated | immediately after surgery |
| Oxygenation index | The oxygenation index after extubation and 1 day after surgery was recorded | after extubation and 1 day after surgery |
| Length of stay in ICU | Length of stay in ICU (patients admitted to ICU due to bed turnover are not counted) | immediately after surgery |
| Duration of hospitalization | Duration of hospitalization were recorded | immediately after admission |
| Incidence of respiratory system related symptoms | Incidence of respiratory system related symptoms within 30 days after surgery was calculated | 30 postoperative days |
| All-cause mortality | All-cause mortality within 30 days after surgery was calculated | 30 postoperative days |
| PPCs related mortality | PPCs related mortality within 30 days after surgery was calculated | 30 postoperative days |