Pulmonary ComplicationsPhase 4NCT02373475
Effect of Perioperative Lung Protective Strategies on the Occurrence of Postoperative Pulmonary Complications in Patients Undergoing Lumbar Spinal Surgery in the Prone Position
A Phase 4 study testing Conventional ventilation and Protective lung ventilation in people with Pulmonary Complications, run by Yonsei University at 1 site in South Korea.
Trial summary
Postoperative pulmonary complications are main cause of overall perioperative morbidity and mortality in the patients following general anesthesia. A protective ventilation strategy refers to the use of low VT (in the range of 4-8 ml/kg of the predicted body weight) with positive end-expiratory pressure (PEEP), with… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pulmonary Complications
- What is being tested?
- Conventional ventilation and Protective lung ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2015to Jun 2016
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the patient undergoing elective lumbar spine surgery of two hours or more in the prone position
- the age: 19 yrs and older
- the patients had a preoperative risk index for pulmonary complications of more than 2.
Who cannot join
- Patients with altered mental status or increased intracranial pressure
- Body mass index more than 35 kg/m2
- Patients with persistent hemodynamic instability or intractable shock
- Severe cardiac disease defined as New York Heart Association class III or IV or acute coronary syndrome or persistent ventricular tachyarrhythmias
- Recent history of invasive ventilation (within two weeks)
- Recent history of pneumonia, ALI/ARDS or sepsis (within two weeks)
Show all 13Show fewer
- History of pulmonary resection, emphysema or chronic obstructive pulmonary disease (COPD)
- Repeated systemic corticosteroid therapy for acute exacerbations of COPD or asthma
- Recent immunosuppressive medication defined as need of chemotherapy or radiation therapy (within two months)
- History of neuromuscular disease
- Emergency operation
- Patient refusal
- Pregnancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine
Seoul, Seoul, 120-752
About this study
Postoperative pulmonary complications are main cause of overall perioperative morbidity and mortality in the patients following general anesthesia. A protective ventilation strategy refers to the use of low VT (in the range of 4-8 ml/kg of the predicted body weight) with positive end-expiratory pressure (PEEP), with or without recruitment maneuver. Protective ventilation has been considered the optimal practice in patients suffering from the acute respiratory distress syndrome (ARDS). However, few human studies have assessed how to ventilate healthy lungs in patients undergoing general anesthesia, especially in prone position. Prior studies reported that in the patients undergoing major abdominal surgery in supine position, intraoperative lung protective ventilator settings had the potential to protect against pulmonary complications. Therefore, the investigators planned this study to better specify the effect of intraoperative protective ventilation in surgical patients in the prone position.
- Conditions
- Pulmonary Complications
- Being tested
- Conventional ventilation, Protective lung ventilation
- Keywords
- spine surgery, prone position, intraoperative lung protective strategies, postoperative pulmonary complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional ventilationOther
Conventional ventilation with TV of 10 mL/kg predicted body weight (PBW) without positive end-expiratory pressure (PEEP) during the surgery under general anesthesia
Protective lung ventilationOther
Protective lung ventilation with TV of 6 mL/kg PBW, PEEP of 6 cmH2O and recruitment maneuver during the surgery under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Conventional ventilation | Experimental | Conventional ventilation with TV of 10 mL/kg predicted body weight (PBW) without positive end-expiratory pressure (PEEP) during the surgery under general anesthesia Receives: Other: Conventional ventilation |
| Protective lung ventilation | Active comparator | Protective lung ventilation with TV of 6 mL/kg PBW, PEEP of 6 cmH2O and recruitment maneuver during the surgery under general anesthesia Receives: Other: Protective lung ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
forced vital capacity (FVC)
The changes in the pulmonary functional tests [forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1)].Pulmonary functional tests were performed at the bedside by using a spirometer while the patients in a seated, comfortable position.
Measured: 3 days after the spine surgery
forced expiratory volume in 1 second (FEV1)
The changes in the pulmonary functional tests [forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1)].Pulmonary functional tests were performed at the bedside by using a spirometer while the patients in a seated, comfortable position.
Measured: 3 days after the spine surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary ComplicationsStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373475
- Sponsor's protocol ID
- 4-2014-0955
- Status last verified
- Jun 2016
- First submitted
- 10 Feb 2015
- Last updated
- 15 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Lung Protective Strategies on the Occurrence of Postoperative Pulmonary Complications in Patients Undergoing Lumbar Spinal Surgery in the Prone Position
- ClinicalTrials.gov ID
- NCT02373475
- Acronym / sponsor ID
- 4-2014-0955
- Conditions
- Pulmonary Complications
- Keywords
- spine surgery, prone position, intraoperative lung protective strategies, postoperative pulmonary complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 27 Feb 2015 (estimated)
- 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.
Postoperative pulmonary complications are main cause of overall perioperative morbidity and mortality in the patients following general anesthesia. A protective ventilation strategy refers to the use of low VT (in the range of 4-8 ml/kg of the predicted body weight) with positive end-expiratory pressure (PEEP), with or without recruitment maneuver. Protective ventilation has been considered the optimal practice in patients suffering from the acute respiratory distress syndrome (ARDS). However, few human studies have assessed how to ventilate healthy lungs in patients undergoing general anesthesia, especially in prone position. Prior studies reported that in the patients undergoing major abdominal surgery in supine position, intraoperative lung protective ventilator settings had the potential to protect against pulmonary complications. Therefore, the investigators planned this study to better specify the effect of intraoperative protective ventilation in surgical patients in the prone position.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional ventilation | Experimental | Other: Conventional ventilationConventional ventilation with TV of 10 mL/kg predicted body weight (PBW) without positive end-expiratory pressure (PEEP) during the surgery under general anesthesia |
| Protective lung ventilation | Active comparator | Other: Protective lung ventilationProtective lung ventilation with TV of 6 mL/kg PBW, PEEP of 6 cmH2O and recruitment maneuver during the surgery under general anesthesia |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- the patient undergoing elective lumbar spine surgery of two hours or more in the prone position
- the age: 19 yrs and older
- the patients had a preoperative risk index for pulmonary complications of more than 2.
Key exclusion criteria (13 listed)
- Patients with altered mental status or increased intracranial pressure
- Body mass index more than 35 kg/m2
- Patients with persistent hemodynamic instability or intractable shock
- Severe cardiac disease defined as New York Heart Association class III or IV or acute coronary syndrome or persistent ventricular tachyarrhythmias
- Recent history of invasive ventilation (within two weeks)
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 |
|---|---|---|
| Conventional ventilationConventional ventilation with TV of 10 mL/kg predicted body weight (PBW) without positive end-expiratory pressure (PEEP) during the surgery under general anesthesia | Other | Conventional ventilation |
| Protective lung ventilationProtective lung ventilation with TV of 6 mL/kg PBW, PEEP of 6 cmH2O and recruitment maneuver during the surgery under general anesthesia | Other | Protective lung ventilation |
Primary outcome
forced vital capacity (FVC)
Time frame: 3 days after the spine surgery
The changes in the pulmonary functional tests [forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1)].Pulmonary functional tests were performed at the bedside by using a spirometer while the patients in a seated, comfortable position.
forced expiratory volume in 1 second (FEV1)
Time frame: 3 days after the spine surgery
The changes in the pulmonary functional tests [forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1)].Pulmonary functional tests were performed at the bedside by using a spirometer while the patients in a seated, comfortable position.
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 15 Jun 2016.
Related trials for Pulmonary Complications
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingPhase 1
Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma
Mesothelioma, Neoplasms
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 Phase 4 study testing Conventional ventilation and Protective lung ventilation in people with Pulmonary Complications, run by Yonsei University at 1 site in South Korea.
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 3 inclusion and 13 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 15 Jun 2016. 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
forced vital capacity (FVC) (time frame: 3 days after the spine surgery). The study lists 2 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 15 Jun 2016.