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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
300
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.
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.
Renji Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGThe 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
Time frame: 7 postoperative days
Secondary diagnosis of PPCs
PPCs were defined by established criteria and included respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonitis
Time frame: 7 postoperative days
Grading of PPCs
Grading of PPCs evaluated by Clavien-Dindo classification
Time frame: 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)
Time frame: 30 postoperative days
Extubation time
The time from the end of surgery to extubation was calculated
Time frame: immediately after surgery
Oxygenation index
The oxygenation index after extubation and 1 day after surgery was recorded
Time frame: 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)
Time frame: immediately after surgery
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Duration of hospitalization
Duration of hospitalization were recorded
Time frame: immediately after admission
Incidence of respiratory system related symptoms
Incidence of respiratory system related symptoms within 30 days after surgery was calculated
Time frame: 30 postoperative days
All-cause mortality
All-cause mortality within 30 days after surgery was calculated
Time frame: 30 postoperative days
PPCs related mortality
PPCs related mortality within 30 days after surgery was calculated
Time frame: 30 postoperative days