AtelectasisPCV-VGNCT03614845
Evaluation of Effect of Different Ventilator Mods on Atelectasis in Patients Undergoing Laparoscopic Surgery
A study testing VCV, PCV-VG and lung ultrasonography in people with Atelectasis and Atelectases, Postoperative Pulmonary, run by Derince Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
In this study researchers aim to evaluate effect of different ventilation modalities on the developments of atelectasis by using ultrasound. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Atelectasis, Atelectases, Postoperative Pulmonary
- What is being tested?
- VCV, PCV-VG and lung ultrasonography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Sep 2018to 15 Sep 2019
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- undergoing laparoscopic surgery
- ASA Status I-II
Who cannot join
- Gastroesophageal reflux
- obstructive sleep apnea syndrome
- BMI>30
- severe lung and heart disease
- ASA Status III-IV
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Marmara University School of Medicine
Istanbul
Derince Research and Training Hospital
Kocaeli, 41900
About this study
Official title: Evaluation of Effect of Different Ventilator Mods on Atelectasis in Patients Undergoing Laparoscopic Surgery: a Prospective Randomized Controlled Clinical Trial
In this study researchers aim to evaluate effect of different ventilation modalities on the developments of atelectasis by using ultrasound.
Read the detailed description
Patients undergoing laparoscopic surgery will be randomly assigned either volume controlled ventilation group or pressure controlled volume guaranteed ventilation group. All patients will be performed lung ultrasonography pre and postoperatively to evaluate the development of lung atelectasis and effect of different ventilation modalities on the development of atelectasis.
- Conditions
- Atelectasis, Atelectases, Postoperative Pulmonary
- Being tested
- VCV, PCV-VG, lung ultrasonography
- Keywords
- postoperative atelectasis, mechanical ventilation, laparoscopic surgery, lung ultrasonography, volume controlled ventilation, pressure controlled
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VCVProcedure or surgery
after induction for anesthesia patients will be supported by mechanical ventilation on volume controlled ventilation mode
PCV-VGProcedure or surgery
after induction for anesthesia patients will be supported by mechanical ventilation on pressure controlled and volume guaranteed ventilation mode
lung ultrasonographyDiagnostic test
all patients will be performed lung ultrasonography pre and postoperatively
| Study group | Role | What they receive |
|---|---|---|
| VCV-Lung Ultrasonography | Active comparator | patients undergoing laparoscopic surgery will be performed pre and postoperatively lung ultrasonography. after induction of anesthesia patients will be supported by mechanical ventilation on volume controlled ventilation mode. Receives: Procedure: VCV; Diagnostic Test: lung ultrasonography |
| PCV-VG- Lung Ultrasonography | Active comparator | patients undergoing laparoscopic surgery will be performed pre and postoperatively lung ultrasonography.after induction of anesthesia patients will be supported by mechanical ventilation on pressure controlled volume guaranteed mode Receives: Procedure: PCV-VG; Diagnostic Test: lung ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of different ventilation mods on development of peroperative atelectasis
Patients undergoing laparoscopic surgery will be assigned either volume controlled mode or pressure support volume guaranteed mode. After the operation a researcher will perform lung ultrasonography postoperative at minute 5. Researcher will detect 6 region of each lung totally 12 regions . The researcher will record the modified and original lung ultrasonography scores (LUS Score) of the patients. LUS Score is a scoring system to evaluate atelectasis of lung and scores 1-3 points for each region (Min score 0 max score 36)
Measured: at minute 5 in postoperative care unit
Secondary outcomes (1)
Effect of different ventilation mods on development of peroperative atelectasis
Patients undergoing laparoscopic surgery will be assigned either volume controlled mode or pressure support volume guaranteed mode. After the operation a researcher will perform lung ultrasonography in postoperative care unit at minute 30. Researcher will detect 6 region of each lung totally 12 regions . The researcher will record the modified and original lung ultrasonography scores (LUS Score) of the patients. LUS Score is a scoring system to evaluate atelectasis of lung and scores 1-3 points for each region.(Min score 0 max score 36)
Measured: at minute 30 in postoperative care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start1 Sep 2018
- Primary completion15 Sep 2019
- Study completion15 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtelectasisStudies 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derince Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Zeynep Turan, Derince Training and Research Hospital
- Investigators
- Ayten Saracoglu, Study director, Marmara Unıversity Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614845
- Sponsor's protocol ID
- DerinceTRH-006
- Acronym
- PCV-VG
- Status last verified
- Nov 2019
- First submitted
- 22 Jul 2018
- Last updated
- 26 Nov 2019
- 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 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effect of Different Ventilator Mods on Atelectasis in Patients Undergoing Laparoscopic Surgery: a Prospective Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03614845
- Acronym / sponsor ID
- PCV-VG / DerinceTRH-006
- Conditions
- Atelectasis, Atelectases, Postoperative Pulmonary
- Keywords
- postoperative atelectasis, mechanical ventilation, laparoscopic surgery, lung ultrasonography, volume controlled ventilation, pressure controlled
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Derince Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 3 Aug 2018 (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.
In this study researchers aim to evaluate effect of different ventilation modalities on the developments of atelectasis by using ultrasound.
Detailed description
Patients undergoing laparoscopic surgery will be randomly assigned either volume controlled ventilation group or pressure controlled volume guaranteed ventilation group. All patients will be performed lung ultrasonography pre and postoperatively to evaluate the development of lung atelectasis and effect of different ventilation modalities on the development of atelectasis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VCV-Lung Ultrasonography | Active comparator | Procedure: VCV, Diagnostic Test: lung ultrasonographypatients undergoing laparoscopic surgery will be performed pre and postoperatively lung ultrasonography. after induction of anesthesia patients will be supported by mechanical ventilation on volume controlled ventilation mode. |
| PCV-VG- Lung Ultrasonography | Active comparator | Procedure: PCV-VG, Diagnostic Test: lung ultrasonographypatients undergoing laparoscopic surgery will be performed pre and postoperatively lung ultrasonography.after induction of anesthesia patients will be supported by mechanical ventilation on pressure controlled volume guaranteed mode |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- undergoing laparoscopic surgery
- ASA Status I-II
Key exclusion criteria (5 listed)
- Gastroesophageal reflux
- obstructive sleep apnea syndrome
- BMI>30
- severe lung and heart disease
- ASA Status III-IV
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 |
|---|---|---|
| VCVafter induction for anesthesia patients will be supported by mechanical ventilation on volume controlled ventilation mode | Procedure or surgery | VCV-Lung Ultrasonography |
| PCV-VGafter induction for anesthesia patients will be supported by mechanical ventilation on pressure controlled and volume guaranteed ventilation mode | Procedure or surgery | PCV-VG- Lung Ultrasonography |
| lung ultrasonographyall patients will be performed lung ultrasonography pre and postoperatively | Diagnostic test | PCV-VG- Lung Ultrasonography, VCV-Lung Ultrasonography |
Primary outcome
Effect of different ventilation mods on development of peroperative atelectasis
Time frame: at minute 5 in postoperative care unit
Patients undergoing laparoscopic surgery will be assigned either volume controlled mode or pressure support volume guaranteed mode. After the operation a researcher will perform lung ultrasonography postoperative at minute 5. Researcher will detect 6 region of each lung totally 12 regions . The researcher will record the modified and original lung ultrasonography scores (LUS Score) of the patients. LUS Score is a scoring system to evaluate atelectasis of lung and scores 1-3 points for each region (Min score 0 max score 36)
1 secondary outcome
Effect of different ventilation mods on development of peroperative atelectasis
Time frame: at minute 30 in postoperative care unit
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 26 Nov 2019.
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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.
Ayten Saracoglu study director
Marmara Unıversity Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VCV, PCV-VG and lung ultrasonography in people with Atelectasis and Atelectases, Postoperative Pulmonary, run by Derince Training and Research Hospital at 2 sites in Turkey (Türkiye).
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 2 inclusion and 5 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 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Effect of different ventilation mods on development of peroperative atelectasis (time frame: at minute 5 in postoperative care unit). 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 26 Nov 2019.