Pulmonary DiseaseNCT06202586
Effect of Different Oxygen Concentration on Postoperative Pulmonary Complications After Pulmonary Reexpansion
A study testing low FiO2 and high FiO2 in people with Pulmonary Disease, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Pulmonary Disease
- What is being tested?
- low FiO2 and high FiO2
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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;
- 6. Pregnant women; 7. Preoperative Hb<70g/L or haematocrit<30%.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, Shanghai Municipality, 200127
Wang Xiaojing, M.D., +8613764152169, yoyowxj@163.com
About this study
Official title: 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.
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.
Read the 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
- Conditions
- Pulmonary Disease
- Being tested
- low FiO2, high FiO2
- Keywords
- postoperative pulmonary complications, thoracic surgery, inspiratory oxygen fraction
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low FiO2Procedure or surgery
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.
high FiO2Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: low FiO2 |
| 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. Receives: Procedure: high FiO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 postoperative days
Secondary outcomes (10)
Secondary diagnosis of PPCs
PPCs were defined by established criteria and included respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonitis
Measured: 7 postoperative days
Grading of PPCs
Grading of PPCs evaluated by Clavien-Dindo classification
Measured: 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)
Measured: 30 postoperative days
Extubation time
The time from the end of surgery to extubation was calculated
Measured: immediately after surgery
Oxygenation index
The oxygenation index after extubation and 1 day after surgery was recorded
Measured: 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)
Measured: immediately after surgery
Duration of hospitalization
Duration of hospitalization were recorded
Measured: immediately after admission
Incidence of respiratory system related symptoms
Incidence of respiratory system related symptoms within 30 days after surgery was calculated
Measured: 30 postoperative days
All-cause mortality
All-cause mortality within 30 days after surgery was calculated
Measured: 30 postoperative days
PPCs related mortality
PPCs related mortality within 30 days after surgery was calculated
Measured: 30 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wang Xiaojing, M.D., Study director, Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202586
- Sponsor's protocol ID
- The DOC-PCT trial
- Status last verified
- Jan 2024
- First submitted
- 1 Jan 2024
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06202586
- Acronym / sponsor ID
- The DOC-PCT trial
- Conditions
- Pulmonary Disease
- Keywords
- postoperative pulmonary complications, thoracic surgery, inspiratory oxygen fraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Received low FiO2 | Experimental | Procedure: low FiO2Patients undergoing elective thoracic surgery were treated with 30% FiO2 after pulmonary reexpansion following one-lung ventilation and 2-hour postoperative. |
| Received high FiO2 | Active comparator | Procedure: high FiO2Patients undergoing elective thoracic surgery were treated with 80% FiO2 after pulmonary reexpansion following one-lung ventilation and 2-hour postoperative. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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;
- 6. Pregnant women; 7. Preoperative Hb<70g/L or haematocrit<30%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low FiO2FiO2 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. | Procedure or surgery | Received low FiO2 |
| high FiO2FiO2 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. | Procedure or surgery | Received high FiO2 |
Primary outcome
The incidence of a composite of postoperative pulmonary complications (PPCs) within the first 7 postoperative days
Time frame: 7 postoperative days
The incidence of a composite of PPCs within the first 7 postoperative days evaluated by established criteria
10 secondary outcomes
Secondary diagnosis of PPCs
Time frame: 7 postoperative days
Grading of PPCs
Time frame: 7 postoperative days
Grading of surgical complications
Time frame: 30 postoperative days
Extubation time
Time frame: immediately after surgery
Oxygenation index
Time frame: after extubation and 1 day after surgery
Length of stay in ICU
Time frame: immediately after surgery
Duration of hospitalization
Time frame: immediately after admission
Incidence of respiratory system related symptoms
Time frame: 30 postoperative days
All-cause mortality
Time frame: 30 postoperative days
PPCs related mortality
Time frame: 30 postoperative days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wang Xiaojing, M.D. study director
Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low FiO2 and high FiO2 in people with Pulmonary Disease, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wang Xiaojing, M.D. (+8613764152169, yoyowxj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of a composite of postoperative pulmonary complications (PPCs) within the first 7 postoperative days (time frame: 7 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.