RespirationNCT06247943
Lung Protective Ventilation Strategies
A study testing Lung Protective Ventilation Strategy and regular ventilation in people with Respiration, run by Tianjin Medical University General Hospital at 1 site in China.
Trial summary
Obesity is becoming a common condition and bariatric metabolic surgery is one of the main options for treating morbid obesity. However, since most patients undergoing robotic bariatric surgery are class III obese, it brings new challenges to perioperative anesthesia management. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Respiration
- What is being tested?
- Lung Protective Ventilation Strategy and regular ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 17 Mar 2024
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Obese patients with ASA grade Ⅰ ~ Ⅲ No obvious abnormality in preoperative lung function and blood gas analysis results Undergoing robotic bariatric surgery
Who cannot join
- Had been mechanically ventilated 2 weeks before surgery Thoracic deformity Neuromuscular disease Significant abnormalities in vital organ function Combined pneumothorax or pulmonary herniation Participating in other clinical intervention trials or refusing general anesthesia with tracheal intubation Emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lung Protective Ventilation Strategies to Improve Oxygenation Function and Respiratory Mechanics in Patients Undergoing Robotic Bariatric Surgery
Obesity is becoming a common condition and bariatric metabolic surgery is one of the main options for treating morbid obesity. However, since most patients undergoing robotic bariatric surgery are class III obese, it brings new challenges to perioperative anesthesia management. Here, we explored the effects of lung-protective ventilation strategies on pulmonary oxygenation function and respiratory mechanics in patients undergoing robotic bariatric surgery.
Read the detailed description
Forty obese patients who underwent robotic bariatric surgery in our hospital were selected and randomly divided into a lung-protective ventilation strategy group (Group P) and a control group (Group C). The volume-controlled mode was used to assist ventilation, and the inspiratory/expiratory ratio (I: E) was 1:2. Tidal volume (VT) was set according to the Predicted body weight (PBW) throughout the whole procedure, and in group C, VT was 9 ml /kg without Positive end-expiratory pressure (PEEP), and the inhaled oxygen concentration (Fraction of oxygen) was 0.5 ml /kg, while the inspiratory oxygen concentration (Fraction of oxygen) was 0.5 ml /kg. Group C: VT 9ml /kg, no Positive end-expiratory pressure (PEEP), Fraction of inspiration O2 (FiO2) of 60%; Group P: the ventilation mode was the same as that of Group C from tracheal intubation to the beginning of pneumoperitoneum for 10 minutes, and after 10 minutes of pneumoperitoneum, the ventilation mode was the same as that of Group C. After the pneumoperitoneum for 10 minutes, the ventilation mode was VT 7ml/kg, PEEP 6cmH2O, FiO2 of 40%, and the plateau pressure was maintained at <30cmH2O. In both groups, the intraoperative gas flow was 2L/min, and SpO2 was maintained at ≥95%; if it could not be maintained, the oxygenation function of the patients could be improved by adjusting the ventilation parameters and strategies; meanwhile, the respiratory rate (RR) was adjusted to maintain the End-tidal carbon dioxide partial pressure (PETCO2) at ≥30%, and the end-tidal carbon dioxide partial pressure (PETCO2) was maintained at ≥30%, and the end-tidal carbon dioxide partial pressure (PETCO2) was maintained at ≥30%. The respiratory mechanical parameters: tidal volume, RR, airway peak pressure (PPeak), plateau pressure (PPeak), and plateau pressure (PPeak) were recorded at 5 minutes after tracheal intubation (T0), 10 minutes after the start of the pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the pneumoperitoneum was closed (T4). pressure (PPeak), and plateau pressure (PPlate), and calculate the dynamic lung compliance; arterial blood was drawn at T0, T1, T2, T3, and T4, respectively, and the arterial partial pressure of oxygen (PaO2) and the arterial partial pressure of carbon dioxide (Arterial CO2) were measured. The arterial partial pressure of oxygen (PaO2) and arterial carbon dioxide pressure (PaCO2) were measured, and the oxygenation index (OI) was calculated.
- Conditions
- Respiration
- Being tested
- Lung Protective Ventilation Strategy, regular ventilation
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Protective Ventilation StrategyProcedure or surgery
After 10 minutes of pneumoperitoneum, VT 7 ml/kg was used, PEEP 6 cmH2O, FiO2 was 40%, and plateau pressure <30 cmH2O was maintained throughout.
regular ventilationProcedure or surgery
VT 9ml /kg without PEEP, FiO2 of 60%
| Study group | Role | What they receive |
|---|---|---|
| Lung Protective Ventilation Strategy Group | Experimental | Use of lung-protective ventilation strategies Receives: Procedure: Lung Protective Ventilation Strategy |
| Control Group | Other | Use of general ventilation strategies Receives: Procedure: regular ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory mechanics
plateau airway pressure
Measured: 5 minutes after tracheal intubation (T0), 10 minutes after the start of pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the closure of the pneumoperitoneum (T4)
oxygenation
Oxygenation index
Measured: 5 minutes after tracheal intubation (T0), 10 minutes after the start of pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the closure of the pneumoperitoneum (T4)
oxygenation
arterial oxygen partial pressure
Measured: 5 minutes after tracheal intubation (T0), 10 minutes after the start of pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the closure of the pneumoperitoneum (T4)
Respiratory mechanics
peak airway pressure
Measured: 5 minutes after tracheal intubation (T0), 10 minutes after the start of pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the closure of the pneumoperitoneum (T4)
Respiratory mechanics
end-tidal carbon dioxide partial pressure
Measured: 5 minutes after tracheal intubation (T0), 10 minutes after the start of pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the closure of the pneumoperitoneum (T4)
Secondary outcomes (2)
Hemodynamics
mean arterial pressure
Measured: 5 minutes after tracheal intubation (T0), 10 minutes after the start of pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the closure of the pneumoperitoneum (T4)
complications
postoperative pulmonary complications
Measured: postoperative days 1, 3, and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Jan 2024
- Primary completion16 Mar 2024
- Study completion17 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RespirationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guolin Wang, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247943
- Sponsor's protocol ID
- GWang026
- Status last verified
- Mar 2024
- First submitted
- 25 Dec 2023
- Last updated
- 21 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Protective Ventilation Strategies to Improve Oxygenation Function and Respiratory Mechanics in Patients Undergoing Robotic Bariatric Surgery
- ClinicalTrials.gov ID
- NCT06247943
- Acronym / sponsor ID
- GWang026
- Conditions
- Respiration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 16 Mar 2024 (actual)
- Study completion
- 17 Mar 2024 (actual)
- First posted
- 8 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.
Obesity is becoming a common condition and bariatric metabolic surgery is one of the main options for treating morbid obesity. However, since most patients undergoing robotic bariatric surgery are class III obese, it brings new challenges to perioperative anesthesia management. Here, we explored the effects of lung-protective ventilation strategies on pulmonary oxygenation function and respiratory mechanics in patients undergoing robotic bariatric surgery.
Detailed description
Forty obese patients who underwent robotic bariatric surgery in our hospital were selected and randomly divided into a lung-protective ventilation strategy group (Group P) and a control group (Group C). The volume-controlled mode was used to assist ventilation, and the inspiratory/expiratory ratio (I: E) was 1:2. Tidal volume (VT) was set according to the Predicted body weight (PBW) throughout the whole procedure, and in group C, VT was 9 ml /kg without Positive end-expiratory pressure (PEEP), and the inhaled oxygen concentration (Fraction of oxygen) was 0.5 ml /kg, while the inspiratory oxygen concentration (Fraction of oxygen) was 0.5 ml /kg. Group C: VT 9ml /kg, no Positive end-expiratory pressure (PEEP), Fraction of inspiration O2 (FiO2) of 60%; Group P: the ventilation mode was the same as that of Group C from tracheal intubation to the beginning of pneumoperitoneum for 10 minutes, and after 10 minutes of pneumoperitoneum, the ventilation mode was the same as that of Group C. After the pneumoperitoneum for 10 minutes, the ventilation mode was VT 7ml/kg, PEEP 6cmH2O, FiO2 of 40%, and the plateau pressure was maintained at <30cmH2O. In both groups, the intraoperative gas flow was 2L/min, and SpO2 was maintained at ≥95%; if it could not be maintained, the oxygenation function of the patients could be improved by adjusting the ventilation parameters and strategies; meanwhile, the respiratory rate (RR) was adjusted to maintain the End-tidal carbon dioxide partial pressure (PETCO2) at ≥30%, and the end-tidal carbon dioxide partial pressure (PETCO2) was maintained at ≥30%, and the end-tidal carbon dioxide partial pressure (PETCO2) was maintained at ≥30%. The respiratory mechanical parameters: tidal volume, RR, airway peak pressure (PPeak), plateau pressure (PPeak), and plateau pressure (PPeak) were recorded at 5 minutes after tracheal intubation (T0), 10 minutes after the start of the pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the pneumoperitoneum was closed (T4). pressure (PPeak), and plateau pressure (PPlate), and calculate the dynamic lung compliance; arterial blood was drawn at T0, T1, T2, T3, and T4, respectively, and the arterial partial pressure of oxygen (PaO2) and the arterial partial pressure of carbon dioxide (Arterial CO2) were measured. The arterial partial pressure of oxygen (PaO2) and arterial carbon dioxide pressure (PaCO2) were measured, and the oxygenation index (OI) was calculated.
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 |
|---|---|---|
| Lung Protective Ventilation Strategy Group | Experimental | Procedure: Lung Protective Ventilation StrategyUse of lung-protective ventilation strategies |
| Control Group | Other | Procedure: regular ventilationUse of general ventilation strategies |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Obese patients with ASA grade Ⅰ ~ Ⅲ No obvious abnormality in preoperative lung function and blood gas analysis results Undergoing robotic bariatric surgery
Key exclusion criteria (1 listed)
- Had been mechanically ventilated 2 weeks before surgery Thoracic deformity Neuromuscular disease Significant abnormalities in vital organ function Combined pneumothorax or pulmonary herniation Participating in other clinical intervention trials or refusing general anesthesia with tracheal intubation Emergency surgery
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 |
|---|---|---|
| Lung Protective Ventilation StrategyAfter 10 minutes of pneumoperitoneum, VT 7 ml/kg was used, PEEP 6 cmH2O, FiO2 was 40%, and plateau pressure <30 cmH2O was maintained throughout. | Procedure or surgery | Lung Protective Ventilation Strategy Group |
| regular ventilationVT 9ml /kg without PEEP, FiO2 of 60% | Procedure or surgery | Control Group |
Primary outcome
Respiratory mechanics
Time frame: 5 minutes after tracheal intubation (T0), 10 minutes after the start of pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the closure of the pneumoperitoneum (T4)
plateau airway pressure
oxygenation
Time frame: 5 minutes after tracheal intubation (T0), 10 minutes after the start of pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the closure of the pneumoperitoneum (T4)
Oxygenation index
oxygenation
Time frame: 5 minutes after tracheal intubation (T0), 10 minutes after the start of pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the closure of the pneumoperitoneum (T4)
arterial oxygen partial pressure
Respiratory mechanics
Time frame: 5 minutes after tracheal intubation (T0), 10 minutes after the start of pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the closure of the pneumoperitoneum (T4)
peak airway pressure
Respiratory mechanics
Time frame: 5 minutes after tracheal intubation (T0), 10 minutes after the start of pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the closure of the pneumoperitoneum (T4)
end-tidal carbon dioxide partial pressure
2 secondary outcomes
Hemodynamics
Time frame: 5 minutes after tracheal intubation (T0), 10 minutes after the start of pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the closure of the pneumoperitoneum (T4)
complications
Time frame: postoperative days 1, 3, and 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung Protective Ventilation Strategy and regular ventilation in people with Respiration, run by Tianjin Medical University General 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: finished, as of the sponsor's last update on 21 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory mechanics (time frame: 5 minutes after tracheal intubation (T0), 10 minutes after the start of pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the closure of the pneumoperitoneum (T4)). The study lists 5 primary outcomes in all. 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 21 Mar 2024.