Ventilator-Induced Lung InjuryNCT03165760
Protective Mechanical Ventilation and Risk of Postoperative Complications in Abdominal Surgery
A study testing protective ventilation in people with Ventilator-Induced Lung Injury and Mechanical Ventilation Complication, run by Mongi Slim Hospital.
Trial summary
Randomized controlled trial, comparing two groups of 40 patients each scheduled for open major abdominal surgery. The intervention group was ventilated with a protective strategy consisting on a low Tidal volume (Vt) (6ml/kg of predicted body weight (PBW)), positive end expiratory pressure (PEEP) = 10 cm H2O and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventilator-Induced Lung Injury, Mechanical Ventilation Complication, Postoperative Complications
- What is being tested?
- protective ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2015to 31 Dec 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I or II, planned for open abdominal surgery lasting more than 2 hours under general anesthesia
Who cannot join
- Patients were not included if they had specially acute respiratory disease, severe asthma or emphysema, sleep apnea syndrome, septic shock and BMI < 16 or > 35 Kg/m2. They were excluded in case of serious peroperative anesthetic complications or hemorrhagic shock.
About this study
Randomized controlled trial, comparing two groups of 40 patients each scheduled for open major abdominal surgery. The intervention group was ventilated with a protective strategy consisting on a low Tidal volume (Vt) (6ml/kg of predicted body weight (PBW)), positive end expiratory pressure (PEEP) = 10 cm H2O and recruitment manoeuvres (RM) after disconnection from the ventilator, the control group had classic ventilation (Vt = 8 ml/kg of PBW, PEEP = 4 cmH2O and no RM).
Read the detailed description
This randomized controlled trial, was approved by the institutional ethics committee of our hospital. Informed consent was obtained from all the participants before randomization. Investigators included 80 patients (40 in each group), ASA I or II, planned for open abdominal surgery lasting more than 2 hours under general anesthesia.
Patients were not included if they had specially acute respiratory disease, severe asthma or emphysema, sleep apnea syndrome, septic shock and body mass index (BMI) < 16 or > 35 Kg/m2. Participants were excluded in case of serious peroperative anesthetic complications or hemorrhagic shock.
Primary endpoint was postoperative pulmonary complications occurring within the first 7 days after surgery (defined as hypoxemia, Broncho-pneumopathy, pulmonary infiltrate, acute respiratory distress syndrome, atelectasis, pleural effusion).
Secondary endpoints for all participants were intra-operative complications (change in SpO2 when dropped less than 90%, hypotension <90 mmHg lasting more than 3 min, need for vasopressor administration, new arrhythmia), postoperative extrapulmonary complications (septic shock, postoperative surgical complications, heart disease complications). Investigators recorded for all participants length of hospital stay and mortality rate were .
Investigators randomly allocated patients before entering to the operating room to:
- Control Group (CG): patients ventilated with Vt of 8 ml/kg of predicted body weight (PBW), a low level of PEEP (4 cm H2O) without RM.
- Protective Ventilation Group (PVG): patients ventilated with a low Vt of 6 ml/Kg of PBW, a high level of PEEP (10 cm H2O), RMs applied after intubation, before extubation and in case of disconnection from the ventilator.
Other ventilation settings, type of anesthesia, fluid administration and post operative pain management were standardized.
In the postoperative period, investigators daily assessed clinical examination and arterial blood gas if pulse oximetry dropped. For all participants, a chest X ray, blood count creatinine and C reactive protein were done at day 1 and day 3.
Data were presented as means and standard deviation [SD] or frequencies. Statistical analyses were performed using SPSS statistical software version 20.0. A p-value of 0.05 was considered significant.
- Conditions
- Ventilator-Induced Lung Injury, Mechanical Ventilation Complication, Postoperative Complications
- Being tested
- protective ventilation
- Keywords
- protective mechanical ventilation
- Medical subject headings
- Ventilator-Induced Lung Injury, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protective ventilationProcedure or surgery
the aim of the intervention is to ovoid Ventilator induced lung injury and inflammatory stress
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Vt = 8 ml/kg of PBW and PEEP = 4 cm H2O |
| protective ventilation group | Experimental | Vt = 6ml/kg of PBW, PEEP = 10 and RM if disconnected Receives: Procedure: protective ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pulmonary complications
Postoperative pulmonary complications occurring within the first 7 days after surgery (defined as hypoxemia, Broncho pneumopathy, pulmonary infiltrate, acute respiratory distress syndrome, atelectasis, pleural effusion)
Measured: Postoperative pulmonary complications within the first 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start1 Jul 2015
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-Induced Lung InjuryStudies 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
- Model description
- randomization is decided when patients are schedueld and according a randomization table
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mongi Slim Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mhamed Sami Mebazaa, Mongi Slim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165760
- Sponsor's protocol ID
- Mongi Slim OR
- Status last verified
- May 2017
- First submitted
- 19 May 2017
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- 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 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Mechanical Ventilation and Risk of Postoperative Complications in Abdominal Surgery
- ClinicalTrials.gov ID
- NCT03165760
- Acronym / sponsor ID
- Mongi Slim OR
- Conditions
- Ventilator-Induced Lung Injury, Mechanical Ventilation Complication, Postoperative Complications
- Keywords
- protective mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 24 May 2017 (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.
Randomized controlled trial, comparing two groups of 40 patients each scheduled for open major abdominal surgery. The intervention group was ventilated with a protective strategy consisting on a low Tidal volume (Vt) (6ml/kg of predicted body weight (PBW)), positive end expiratory pressure (PEEP) = 10 cm H2O and recruitment manoeuvres (RM) after disconnection from the ventilator, the control group had classic ventilation (Vt = 8 ml/kg of PBW, PEEP = 4 cmH2O and no RM).
Detailed description
This randomized controlled trial, was approved by the institutional ethics committee of our hospital. Informed consent was obtained from all the participants before randomization. Investigators included 80 patients (40 in each group), ASA I or II, planned for open abdominal surgery lasting more than 2 hours under general anesthesia.
Patients were not included if they had specially acute respiratory disease, severe asthma or emphysema, sleep apnea syndrome, septic shock and body mass index (BMI) < 16 or > 35 Kg/m2. Participants were excluded in case of serious peroperative anesthetic complications or hemorrhagic shock.
Primary endpoint was postoperative pulmonary complications occurring within the first 7 days after surgery (defined as hypoxemia, Broncho-pneumopathy, pulmonary infiltrate, acute respiratory distress syndrome, atelectasis, pleural effusion).
Secondary endpoints for all participants were intra-operative complications (change in SpO2 when dropped less than 90%, hypotension <90 mmHg lasting more than 3 min, need for vasopressor administration, new arrhythmia), postoperative extrapulmonary complications (septic shock, postoperative surgical complications, heart disease complications). Investigators recorded for all participants length of hospital stay and mortality rate were .
Investigators randomly allocated patients before entering to the operating room to:
- Control Group (CG): patients ventilated with Vt of 8 ml/kg of predicted body weight (PBW), a low level of PEEP (4 cm H2O) without RM.
- Protective Ventilation Group (PVG): patients ventilated with a low Vt of 6 ml/Kg of PBW, a high level of PEEP (10 cm H2O), RMs applied after intubation, before extubation and in case of disconnection from the ventilator.
Other ventilation settings, type of anesthesia, fluid administration and post operative pain management were standardized.
In the postoperative period, investigators daily assessed clinical examination and arterial blood gas if pulse oximetry dropped. For all participants, a chest X ray, blood count creatinine and C reactive protein were done at day 1 and day 3.
Data were presented as means and standard deviation [SD] or frequencies. Statistical analyses were performed using SPSS statistical software version 20.0. A p-value of 0.05 was considered significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomization is decided when patients are schedueld and according a randomization table
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Vt = 8 ml/kg of PBW and PEEP = 4 cm H2O |
| protective ventilation group | Experimental | Procedure: protective ventilationVt = 6ml/kg of PBW, PEEP = 10 and RM if disconnected |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I or II, planned for open abdominal surgery lasting more than 2 hours under general anesthesia
Key exclusion criteria (1 listed)
- Patients were not included if they had specially acute respiratory disease, severe asthma or emphysema, sleep apnea syndrome, septic shock and BMI < 16 or > 35 Kg/m2. They were excluded in case of serious peroperative anesthetic complications or hemorrhagic shock.
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 |
|---|---|---|
| protective ventilationthe aim of the intervention is to ovoid Ventilator induced lung injury and inflammatory stress | Procedure or surgery | protective ventilation group |
Primary outcome
Postoperative pulmonary complications
Time frame: Postoperative pulmonary complications within the first 7 days after surgery
Postoperative pulmonary complications occurring within the first 7 days after surgery (defined as hypoxemia, Broncho pneumopathy, pulmonary infiltrate, acute respiratory distress syndrome, atelectasis, pleural effusion)
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 24 May 2017.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing protective ventilation in people with Ventilator-Induced Lung Injury and Mechanical Ventilation Complication, run by Mongi Slim Hospital.
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 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Postoperative pulmonary complications (time frame: Postoperative pulmonary complications within the first 7 days after surgery). 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 24 May 2017.