Pulmonary Disease
Conditions
Keywords
postoperative pulmonary complications, thoracic surgery, inspiratory oxygen fraction
Brief summary
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.
Detailed description
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
Interventions
PROCEDURElow FiO2
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.
PROCEDUREhigh FiO2
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.
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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
1. Severe lung infection occurs within 1 month; 2. Coronary heart disease or heart failure occurs within 2 or 3 months; 3. Preoperative oxygen saturation is less than 94%; 4, Need continuous oxygen therapy; 5, BMI\>35 kg/m2; 6\. Pregnant women; 7. Preoperative Hb\<70g/L or haematocrit\<30%.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of a composite of postoperative pulmonary complications (PPCs) within the first 7 postoperative days | 7 postoperative days | The incidence of a composite of PPCs within the first 7 postoperative days evaluated by established criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grading of PPCs | 7 postoperative days | Grading of PPCs evaluated by Clavien-Dindo classification |
| Grading of surgical complications | 30 postoperative days | The surgical complications were classified with the Clavien-Dindo classification from grade 0 (no complication) to grade V (death) |
| Extubation time | immediately after surgery | The time from the end of surgery to extubation was calculated |
| Oxygenation index | after extubation and 1 day after surgery | The oxygenation index after extubation and 1 day after surgery was recorded |
| Secondary diagnosis of PPCs | 7 postoperative days | PPCs were defined by established criteria and included respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonitis |
| Duration of hospitalization | immediately after admission | Duration of hospitalization were recorded |
| Incidence of respiratory system related symptoms | 30 postoperative days | Incidence of respiratory system related symptoms within 30 days after surgery was calculated |
| All-cause mortality | 30 postoperative days | All-cause mortality within 30 days after surgery was calculated |
| PPCs related mortality | 30 postoperative days | PPCs related mortality within 30 days after surgery was calculated |
| Length of stay in ICU | immediately after surgery | Length of stay in ICU (patients admitted to ICU due to bed turnover are not counted) |
Countries
China
Contacts
Primary ContactWang Xiaojing, M.D.
Outcome results
None listed