Postoperative Respiratory ComplicationPhase 4NCT02039466
The Effect of Pressure-controlled Ventilation on the Respiratory Complication in Patients Undergoing Laparoscopic Colectomy Compared With Volume-controlled Ventilation
A Phase 4 study of Postoperative Respiratory Complication, run by Chung-Ang University Hospital at 1 site in South Korea.
Trial summary
Postoperative pulmonary complications following abdominal surgery are frequent and associated with increased morbidity and mortality and hospital length of stay. Pressure controlled ventilation will improve oxygenation indices , hemodynamics during anesthesia for laparoscopic colectomy, decreasing postoperative… Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Postoperative Respiratory Complication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to Dec 2014
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status classification
- patients scheduled for laparoscopic colectomy
Who cannot join
- severe cardiopulmonary disease
- patients who cannot understand Korean
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Chung-Ang University Hospital
Seoul, Seoul, 156-755
Seong Deok Kim, MD.PhD, 82-2-6299-2571, ksddeok@cau.ac.kr
Soyoung Yang, MD.PhD.
About this study
Postoperative pulmonary complications following abdominal surgery are frequent and associated with increased morbidity and mortality and hospital length of stay. Pressure controlled ventilation will improve oxygenation indices , hemodynamics during anesthesia for laparoscopic colectomy, decreasing postoperative pulmonary complications.
- Conditions
- Postoperative Respiratory Complication
- Being tested
- volume controlled ventilation, pressure controlled ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
volume controlled ventilationProcedure or surgery
pressure controlled ventilationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| volume controlled ventilation | Active comparator | volume controlled ventilation as a tidal volume of 8 ml/kg (ideal body weight) Receives: Procedure: volume controlled ventilation |
| pressure controlled ventilation | Active comparator | pressure controlled ventilation as a tidal volume of 8 ml/kg (ideal body weight) Receives: Procedure: pressure controlled ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak airway pressure in patients receiving pressure controlled ventilation and volume controlled ventilation
Measured: 40 minutes after pneumoperitoneum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Respiratory ComplicationStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung-Ang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, So Young Yang, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039466
- Sponsor's protocol ID
- ChungAng UH
- Status last verified
- Jul 2014
- First submitted
- 16 Jan 2014
- Last updated
- 11 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pressure-controlled Ventilation on the Respiratory Complication in Patients Undergoing Laparoscopic Colectomy Compared With Volume-controlled Ventilation
- ClinicalTrials.gov ID
- NCT02039466
- Acronym / sponsor ID
- ChungAng UH
- Conditions
- Postoperative Respiratory Complication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Chung-Ang University HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 17 Jan 2014 (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 following abdominal surgery are frequent and associated with increased morbidity and mortality and hospital length of stay. Pressure controlled ventilation will improve oxygenation indices , hemodynamics during anesthesia for laparoscopic colectomy, decreasing postoperative pulmonary complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| volume controlled ventilation | Active comparator | Procedure: volume controlled ventilationvolume controlled ventilation as a tidal volume of 8 ml/kg (ideal body weight) |
| pressure controlled ventilation | Active comparator | Procedure: pressure controlled ventilationpressure controlled ventilation as a tidal volume of 8 ml/kg (ideal body weight) |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status classification
- patients scheduled for laparoscopic colectomy
Key exclusion criteria (2 listed)
- severe cardiopulmonary disease
- patients who cannot understand Korean
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 |
|---|---|---|
| volume controlled ventilation | Procedure or surgery | volume controlled ventilation |
| pressure controlled ventilation | Procedure or surgery | pressure controlled ventilation |
Primary outcome
peak airway pressure in patients receiving pressure controlled ventilation and volume controlled ventilation
Time frame: 40 minutes after pneumoperitoneum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2014.
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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.
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 of Postoperative Respiratory Complication, run by Chung-Ang University Hospital 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 2 inclusion and 2 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 11 Jul 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soyoung Yang, clinical assistant professor (82-2-6299-3160, didth79@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peak airway pressure in patients receiving pressure controlled ventilation and volume controlled ventilation (time frame: 40 minutes after pneumoperitoneum). 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 11 Jul 2014; AzTrials last refreshed its copy on 7 Nov 2026.