Unrecognized ConditionNCT06243146
Titration of Inspired Oxygen to Decrease the Incidence of Postoperative Pulmonary Complications
A study testing Titration of Inspired Oxygen in people with Unrecognized Condition, run by Sichuan Provincial People's Hospital at 1 site in China.
Trial summary
Lung cancer is with the highest incidence rate and mortality among people over 60 years old in China. Postoperative pulmonary complications (PPCs) is the most common complication after pneumonectomy, which has a significant impact on the short-term and long-term prognosis of patients, and is even the primary risk… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Unrecognized Condition
- What is being tested?
- Titration of Inspired Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ① General anesthesia with left bronchial tube intubation; ② Age range from 18 to 80 years old; ③ 18 kg/m2 ≤ BMI ≤ 30 kg/m2; ④ ASA grade I to III; ⑤ Individuals willing to participate in research and sign an informed consent form.
Who cannot join
- ① CT scan indicates preoperative pulmonary infection, atelectasis, and pneumothorax; ② History of respiratory system diseases (COPD, bronchiectasis, pulmonary alveoli, interstitial lung disease, etc.); ③ Previous history of lung surgery; ④ First second forced expiratory volume/estimated value (FEV1%)<60%; ⑤ PaO2<60mmhg (1 mmhg=0.133 kpa) or PaO2/FiO2<300mmhg or SpO2<90% in the suction state; ⑥ History of acute upper respiratory tract infection, acute lung injury, acute respiratory distress syndrome, or respiratory failure within 3 months prior to surgery; ⑦ Combined heart failure (NYHA heart function grading ≥ 3); ⑧ Previous history of stroke and cerebral infarction; ⑨ Severe liver dysfunction (liver failure or Child Pugh score B or C) Chronic renal failure (glomerular filtration rate<30 ml/min) Suffering from mental illness, etc., which is not suitable for the author; æ Individuals who have participated in other clinical trials as subjects within the three months prior to participating in the study The patient refused to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 641400
Zhenglin Yang, MD, 028-87393999, scsrmyyyb@163.com
About this study
Official title: Titration of Inspired Oxygen During One-lung Ventilation to Decrease the Incidence of Postoperative Pulmonary Complications: a Randomized Controlled Trial
Lung cancer is with the highest incidence rate and mortality among people over 60 years old in China. Postoperative pulmonary complications (PPCs) is the most common complication after pneumonectomy, which has a significant impact on the short-term and long-term prognosis of patients, and is even the primary risk factor leading to early postoperative death. High fraction of inspired oxygen (FiO2) is an independent risk factor for PPCs, but it is difficult to achieve oxygenation while avoiding hyperxemia during one lung ventilation (OLV).
We will randomly divide patients who plan to undergo thoracoscopic pulmonary resection into two groups. During OLV, titration will be used to determine the optimal FiO2 for titration group while FiO2 of 80% will be used for mechanical ventilation for control group. The incidence of postoperative PPCs, hypoxia/hyperxemia, severity level of postoperative PPC, postoperative 30 day PPC, increased hospitalization costs, and prolonged hospital stay will be observed in both groups of patients.We will evaluate the effectiveness and safety of titrating inhaled oxygen concentration in lung protection during OLV.
Read the detailed description
Lung cancer is with the highest incidence rate and mortality among people over 60 years old in China. Postoperative pulmonary complications (PPCs) is the most common complication after pneumonectomy, which has a significant impact on the short-term and long-term prognosis of patients, and is even the primary risk factor leading to early postoperative death. High fraction of inspired oxygen (FiO2) is an independent risk factor for PPCs, but it is difficult to achieve oxygenation while avoiding hyperxemia during one lung ventilation (OLV).Elderly patients with decreased lung function are prone to hypoxemia, which is also a high-risk group for postoperative PPCs induced by hyperxemia, with a dual risk of hypoxia and hyperoxia. Perioperative respiratory management is more challenging. Therefore, it is necessary to explore more suitable oxygen supply methods for patients during OLV.
We will randomly divide patients who plan to undergo thoracoscopic pulmonary resection into two groups. All patients will be intubated with a left bronchial tube using visual laryngoscopy. Fiberoptic bronchoscopy will be used to comfirm the optimal localization of the tube. Lung protective ventilation strategy will be used during ventilation. Before OLV, FiO2 of 100% will be used. During OLV, titration will be used to determine the optimal FiO2 for titration group while FiO2 of 80% will be used for mechanical ventilation for control group. After OLV, FiO2 of 50% will be used. The incidence of postoperative PPCs, hypoxia/hyperxemia, severity level of postoperative PPC, postoperative 30 day PPC, increased hospitalization costs, and prolonged hospital，stay will be compared between 2 groups. The effectiveness and safety of titrating inhaled oxygen concentration during OLV will be elevated.
- Conditions
- Unrecognized Condition
- Being tested
- Titration of Inspired Oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titration of Inspired OxygenOther
Titration of Inspired Oxygen During One-Lung Ventilation
| Study group | Role | What they receive |
|---|---|---|
| Titration | Experimental | During OLV, FiO2 starts at 80%. Titration of inspired oxygen using blood gas analysis and SpO2 monitoring. The titration target is arterial blood gas analysis with PaO2 ≤ 150mmHg and 93% ≤ SpO2 ≤ 97%. Receives: Other: Titration of Inspired Oxygen |
| Control | Active comparator | During OLV, FiO2 starts at 80% and remains until the end of OLV. Receives: Other: Titration of Inspired Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pulmonary complications
postoperative pulmonary complications
Measured: first 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start20 Jun 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unrecognized ConditionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Li, Sichuan Provincial People's Hospital
- Investigators
- Peng Li, MD, Study chair, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243146
- Sponsor's protocol ID
- SPPH202311011
- Status last verified
- Oct 2024
- First submitted
- 28 Jan 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Titration of Inspired Oxygen During One-lung Ventilation to Decrease the Incidence of Postoperative Pulmonary Complications: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06243146
- Acronym / sponsor ID
- SPPH202311011
- Conditions
- Unrecognized Condition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Feb 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.
Lung cancer is with the highest incidence rate and mortality among people over 60 years old in China. Postoperative pulmonary complications (PPCs) is the most common complication after pneumonectomy, which has a significant impact on the short-term and long-term prognosis of patients, and is even the primary risk factor leading to early postoperative death. High fraction of inspired oxygen (FiO2) is an independent risk factor for PPCs, but it is difficult to achieve oxygenation while avoiding hyperxemia during one lung ventilation (OLV).
We will randomly divide patients who plan to undergo thoracoscopic pulmonary resection into two groups. During OLV, titration will be used to determine the optimal FiO2 for titration group while FiO2 of 80% will be used for mechanical ventilation for control group. The incidence of postoperative PPCs, hypoxia/hyperxemia, severity level of postoperative PPC, postoperative 30 day PPC, increased hospitalization costs, and prolonged hospital stay will be observed in both groups of patients.We will evaluate the effectiveness and safety of titrating inhaled oxygen concentration in lung protection during OLV.
Detailed description
Lung cancer is with the highest incidence rate and mortality among people over 60 years old in China. Postoperative pulmonary complications (PPCs) is the most common complication after pneumonectomy, which has a significant impact on the short-term and long-term prognosis of patients, and is even the primary risk factor leading to early postoperative death. High fraction of inspired oxygen (FiO2) is an independent risk factor for PPCs, but it is difficult to achieve oxygenation while avoiding hyperxemia during one lung ventilation (OLV).Elderly patients with decreased lung function are prone to hypoxemia, which is also a high-risk group for postoperative PPCs induced by hyperxemia, with a dual risk of hypoxia and hyperoxia. Perioperative respiratory management is more challenging. Therefore, it is necessary to explore more suitable oxygen supply methods for patients during OLV.
We will randomly divide patients who plan to undergo thoracoscopic pulmonary resection into two groups. All patients will be intubated with a left bronchial tube using visual laryngoscopy. Fiberoptic bronchoscopy will be used to comfirm the optimal localization of the tube. Lung protective ventilation strategy will be used during ventilation. Before OLV, FiO2 of 100% will be used. During OLV, titration will be used to determine the optimal FiO2 for titration group while FiO2 of 80% will be used for mechanical ventilation for control group. After OLV, FiO2 of 50% will be used. The incidence of postoperative PPCs, hypoxia/hyperxemia, severity level of postoperative PPC, postoperative 30 day PPC, increased hospitalization costs, and prolonged hospital，stay will be compared between 2 groups. The effectiveness and safety of titrating inhaled oxygen concentration during OLV will be elevated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Titration | Experimental | Other: Titration of Inspired OxygenDuring OLV, FiO2 starts at 80%. Titration of inspired oxygen using blood gas analysis and SpO2 monitoring. The titration target is arterial blood gas analysis with PaO2 ≤ 150mmHg and 93% ≤ SpO2 ≤ 97%. |
| Control | Active comparator | Other: Titration of Inspired OxygenDuring OLV, FiO2 starts at 80% and remains until the end of OLV. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ① General anesthesia with left bronchial tube intubation; ② Age range from 18 to 80 years old; ③ 18 kg/m2 ≤ BMI ≤ 30 kg/m2; ④ ASA grade I to III; ⑤ Individuals willing to participate in research and sign an informed consent form.
Key exclusion criteria (1 listed)
- ① CT scan indicates preoperative pulmonary infection, atelectasis, and pneumothorax; ② History of respiratory system diseases (COPD, bronchiectasis, pulmonary alveoli, interstitial lung disease, etc.); ③ Previous history of lung surgery; ④ First second forced expiratory volume/estimated value (FEV1%)<60%; ⑤ PaO2<60mmhg (1 mmhg=0.133 kpa) or PaO2/FiO2<300mmhg or SpO2<90% in the suction state; ⑥ History of acute upper respiratory tract infection, acute lung injury, acute respiratory distress syndrome, or respiratory failure within 3 months prior to surgery; ⑦ Combined heart failure (NYHA heart function grading ≥ 3); ⑧ Previous history of stroke and cerebral infarction; ⑨ Severe liver dysfunction (liver failure or Child Pugh score B or C) Chronic renal failure (glomerular filtration rate<30 ml/min) Suffering from mental illness, etc., which is not suitable for the author; æ Individuals who have participated in other clinical trials as subjects within the three months prior to participating in the study The patient refused to participate in the study.
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 |
|---|---|---|
| Titration of Inspired OxygenTitration of Inspired Oxygen During One-Lung Ventilation | Other | Control, Titration |
Primary outcome
postoperative pulmonary complications
Time frame: first 7 days
postoperative pulmonary complications
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Unrecognized Condition
Recruiting
Effects of a Specialized Diabetes and Heart Clinic and Detection of Unrecognized Heart Failure in People With Type 2 Diabetes and Cardiovascular Disease
Cardiovascular Disease, Cardiometabolic Diseases
Enrolling by invitationObservational study
RNA to the RESCUE: Evaluation to Assess the Clinical Utility of RNA Sequencing in Establishing a Genetic Diagnosis or Adjudicating a Previously Established Genetic Diagnosis.
Genetic Conditions, Genetic Disorders
RecruitingObservational study
Determination of the Prevalence of Unrecognized Heart Failure Among Patients at Risk in Urban Areas Across Germany Using CMR
Heart Failure With Preserved Ejection Fraction (HFPEF), Renal Dysfunction
RecruitingObservational study
Evaluate DF-003 in ex Vivo Assays Using Peripheral Blood Mononuclear Cell From Subjects With ROSAH Syndrome
Unrecognized Condition
Recruiting
Effects of LH and FSH on Metabolic Regulation in Cumulus Cells
Unrecognized Condition
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.
Peng Li, MD study chair
Sichuan Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Titration of Inspired Oxygen in people with Unrecognized Condition, run by Sichuan Provincial People's 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 31 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chenghong Wang, MD (13488943096, 931405180@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pulmonary complications (time frame: first 7 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 31 Oct 2024.