Intraoperative Mechanical VentilationlapVentNCT02553057
Low Tidal Volume for Lung Protection During Anesthesia of Laparoscopic Surgery in Trendlenburg Position
A study testing mechanical ventilation in people with Intraoperative Mechanical Ventilation, run by AlRefaey Kandeel at 1 site in Egypt.
Trial summary
Mechanical ventilation of patients undergoing laparoscopic surgery may induce lung injury. Since lung protective ventilation has been recommended during anesthesia to prevent ongoing lung injury, so in our study the investigators will compare three different lung protective strategies regarding their lung protective… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Intraoperative Mechanical Ventilation
- What is being tested?
- mechanical ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2015to 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- all patients undergoing laparoscopic colorectal or gynaecologic surgery with expected time more than two hours
Who cannot join
- refusal, preoperative pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
Mechanical ventilation of patients undergoing laparoscopic surgery may induce lung injury. Since lung protective ventilation has been recommended during anesthesia to prevent ongoing lung injury, so in our study the investigators will compare three different lung protective strategies regarding their lung protective effect measured by the incidence of postoperative pulmonary complications, perioperative oxygenation and postoperative inflammatory mediator release.
- Conditions
- Intraoperative Mechanical Ventilation
- Being tested
- mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical ventilationDevice
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | mechanical ventilation with Tidal volume 4 ml/kg and PEEP 8-10 cm H2o Receives: Device: mechanical ventilation |
| Group2 | Active comparator | mechanical ventilation with Tidal volume 6 ml/kg and PEEP 8-10 cm H2o Receives: Device: mechanical ventilation |
| Group 3 | Active comparator | mechanical ventilation with Tidal volume 8 ml/kg and PEEP 8-10 cm H2o Receives: Device: mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pulmonary complications
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative Mechanical VentilationStudies 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
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AlRefaey Kandeel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, AlRefaey Kandeel, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553057
- Sponsor's protocol ID
- DrSamah
- Acronym
- lapVent
- Status last verified
- Sep 2015
- First submitted
- 15 Sep 2015
- Last updated
- 17 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Tidal Volume for Lung Protection During Anesthesia of Laparoscopic Surgery in Trendlenburg Position
- ClinicalTrials.gov ID
- NCT02553057
- Acronym / sponsor ID
- lapVent / DrSamah
- Conditions
- Intraoperative Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- AlRefaey KandeelUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 17 Sep 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.
Mechanical ventilation of patients undergoing laparoscopic surgery may induce lung injury. Since lung protective ventilation has been recommended during anesthesia to prevent ongoing lung injury, so in our study the investigators will compare three different lung protective strategies regarding their lung protective effect measured by the incidence of postoperative pulmonary complications, perioperative oxygenation and postoperative inflammatory mediator release.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Device: mechanical ventilationmechanical ventilation with Tidal volume 4 ml/kg and PEEP 8-10 cm H2o |
| Group2 | Active comparator | Device: mechanical ventilationmechanical ventilation with Tidal volume 6 ml/kg and PEEP 8-10 cm H2o |
| Group 3 | Active comparator | Device: mechanical ventilationmechanical ventilation with Tidal volume 8 ml/kg and PEEP 8-10 cm H2o |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all patients undergoing laparoscopic colorectal or gynaecologic surgery with expected time more than two hours
Key exclusion criteria (1 listed)
- refusal, preoperative pulmonary disease
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 |
|---|---|---|
| mechanical ventilation | Device | Group 1, Group 3, Group2 |
Primary outcome
postoperative pulmonary complications
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2015.
Related trials for Intraoperative Mechanical Ventilation
Recruiting
PROtective Ventilation With FLOW-Controlled Ventilation
Postoperative Pulmonary Complications (PPCs), Feasibility Studies
RecruitingObservational study
VC-AF vs FCV in Obese Patients Undergoing Laparoscopic Surgery
Anesthesia, Mechanical Ventilation
Recruiting
Impact of Intraoperative Oxygenation Practices on Patient Outcomes
Surgeries Undergoing General Anesthesia
Not yet recruiting
Alveolar Recruitment Maneuver-Induced Hypotension: A Dynamic Consequence and Intraoperative Indicator of Fluid Responsiveness
Hypotension Drug-Induced, General Anesthesia Using Endotracheal Intubation
Not yet recruitingObservational study
Mechanical Power and Pulmonary Complications in CABG Surgery
Postoperative Pulmonary Complications, Coronary Artery Bypass Graft Surgery (CABG)
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 mechanical ventilation in people with Intraoperative Mechanical Ventilation, run by AlRefaey Kandeel at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 17 Sep 2015. 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 Egypt. 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?
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: 1 week). 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 17 Sep 2015.