Surgery--ComplicationsNCT04513262
Effects of Video-Assisted Surgery on Ventilatory Parameters
An observational study of Surgery--Complications, run by Institutul Clinic Fundeni at 1 site in Romania.
Trial summary
The study investigates the effects of induced pneumoperitoneum during surgery on ventilatory parameters including peak inspiratory pressure, lung compliance, end-tidal CO2 at specific time-points: after induction of anaesthesia, after induction of surgery, one-hour and two-hours during surgery, end of surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery--Complications
- What is being tested?
- mechanical ventilation during video-assisted surgery
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteRomania
- Study dates
- 20 Mar 2015to 10 Nov 2018
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: consecutive patients undergoing video-assisted surgery in a university hospital after inclusion and exclusion criteria have been met. Video-assisted surgery is defined by either classic laparoscopic surgery or robotic assisted surgery and the medical decision between the two types of surgery was performed by the attending surgeon prior to patient inclusion (unrelated to the study).
Who may be able to join
- patients who underwent video-assisted surgery by either classic laparoscopy or robotic-assisted surgery.
Who cannot join
- refusal to participate
- conversion of surgery to laparotomy
- need of vasopressure support
- preoperative severe respiratory dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Pneumoperitoneum on Ventilatory Parameters in Patients Undergoing Video-assisted Surgery
The study investigates the effects of induced pneumoperitoneum during surgery on ventilatory parameters including peak inspiratory pressure, lung compliance, end-tidal CO2 at specific time-points: after induction of anaesthesia, after induction of surgery, one-hour and two-hours during surgery, end of surgery.
The effects of pneumoperitoneum are compared between two groups of patients: patients undergoing laparoscopic surgery and patients undergoing robotic-assisted surgery. No intervention was performed in this study and the decision for type of surgery performed was made by the attending surgeon prior to study inclusion
- Conditions
- Surgery--Complications
- Being tested
- mechanical ventilation during video-assisted surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical ventilation during video-assisted surgeryProcedure or surgery
observed variation of ventilatory parameters during video-assisted surgery
| Study group | Role | What they receive |
|---|---|---|
| Video-assisted surgery | Patients undergoing video-assisted major abdominal surgery (VAS) in Trendelenburg position. The decision regarding the type of VAS was made by the attending surgeon prior to study inclusion. Twenty-five consecutive patients undergoing classic laparoscopic surgery and twenty-five patients undergoing robotic-assisted surgery will be included in the study. Receives: Procedure: mechanical ventilation during video-assisted surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
lung compliance
change in lung compliance (mL/cmH2O) before and after induction of pneumoperitoneum in patients undergoing VAS. Lung compliance is automatically calculated by the anesthesia machine during surgery. The study compares the magnitude in change associated with VAS.
Measured: one-hour and two-hours after induction of pneumoperitoneum
Secondary outcomes (1)
arterial to end-tidal CO2 difference
difference in arterial to end-tidal CO2 (mmHg) during surgery. Arterial blood samples and end-tidal CO2 were simultanously obtained at the specific time-points.
Measured: one-hour and two-hours after induction of pneumoperitoneum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start20 Mar 2015
- Primary completion10 Nov 2018
- Study completion10 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery--ComplicationsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institutul Clinic Fundeni
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Popescu Mihai, Institutul Clinic Fundeni
- Investigators
- Dana Tomescu, Prof, Study chair, Fundeni Clinical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513262
- Sponsor's protocol ID
- RAS
- Status last verified
- Aug 2020
- First submitted
- 11 Aug 2020
- Last updated
- 14 Aug 2020
- 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 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pneumoperitoneum on Ventilatory Parameters in Patients Undergoing Video-assisted Surgery
- ClinicalTrials.gov ID
- NCT04513262
- Acronym / sponsor ID
- RAS
- Conditions
- Surgery--Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Institutul Clinic FundeniUniversity, hospital or other
- Study start
- 20 Mar 2015 (actual)
- Primary completion
- 10 Nov 2018 (actual)
- Study completion
- 10 Nov 2018 (actual)
- First posted
- 14 Aug 2020 (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.
The study investigates the effects of induced pneumoperitoneum during surgery on ventilatory parameters including peak inspiratory pressure, lung compliance, end-tidal CO2 at specific time-points: after induction of anaesthesia, after induction of surgery, one-hour and two-hours during surgery, end of surgery.
The effects of pneumoperitoneum are compared between two groups of patients: patients undergoing laparoscopic surgery and patients undergoing robotic-assisted surgery. No intervention was performed in this study and the decision for type of surgery performed was made by the attending surgeon prior to study inclusion
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Video-assisted surgery | – | Procedure: mechanical ventilation during video-assisted surgeryPatients undergoing video-assisted major abdominal surgery (VAS) in Trendelenburg position. The decision regarding the type of VAS was made by the attending surgeon prior to study inclusion. Twenty-five consecutive patients undergoing classic laparoscopic surgery and twenty-five patients undergoing robotic-assisted surgery will be included in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive patients undergoing video-assisted surgery in a university hospital after inclusion and exclusion criteria have been met. Video-assisted surgery is defined by either classic laparoscopic surgery or robotic assisted surgery and the medical decision between the two types of surgery was performed by the attending surgeon prior to patient inclusion (unrelated to the study).
Key inclusion criteria (1 listed)
- patients who underwent video-assisted surgery by either classic laparoscopy or robotic-assisted surgery.
Key exclusion criteria (4 listed)
- refusal to participate
- conversion of surgery to laparotomy
- need of vasopressure support
- preoperative severe respiratory dysfunction
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 during video-assisted surgeryobserved variation of ventilatory parameters during video-assisted surgery | Procedure or surgery | Video-assisted surgery |
Primary outcome
lung compliance
Time frame: one-hour and two-hours after induction of pneumoperitoneum
change in lung compliance (mL/cmH2O) before and after induction of pneumoperitoneum in patients undergoing VAS. Lung compliance is automatically calculated by the anesthesia machine during surgery. The study compares the magnitude in change associated with VAS.
1 secondary outcome
arterial to end-tidal CO2 difference
Time frame: one-hour and two-hours after induction of pneumoperitoneum
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 14 Aug 2020.
- 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.
Dana Tomescu, Prof study chair
Fundeni Clinical Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery--Complications, run by Institutul Clinic Fundeni at 1 site in Romania.
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 4 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 14 Aug 2020. 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 Romania. 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?
lung compliance (time frame: one-hour and two-hours after induction of 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 14 Aug 2020.