RecruitingNot ApplicableNCT06202586

Effect of Different Oxygen Concentration on Postoperative Pulmonary Complications After Pulmonary Reexpansion

Effect of Different Oxygen Concentration on Postoperative Pulmonary Complications After Pulmonary Reexpansion Following One-lung Ventilation in Thoracic Surgery(DOC-PCT Trial)- A Prospective Randomized Controlled Clinical Study.


Sponsor

RenJi Hospital

Enrollment

300 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 79 Years

Exclusion Criteria4

  • Severe lung infection occurs within 1 month;
  • Coronary heart disease or heart failure occurs within 2 or 3 months;
  • Preoperative oxygen saturation is less than 94%; 4, Need continuous oxygen therapy; 5, BMI>35 kg/m2;
  • \. Pregnant women; 7. Preoperative Hb<70g/L or haematocrit<30%.

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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.


Locations(1)

Renji Hospital

Shanghai, Shanghai Municipality, China

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NCT06202586


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