Effects of Video-Assisted Surgery on Ventilatory Parameters

NCT ID: NCT04513262

Last Updated: 2020-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-20

Study Completion Date

2018-11-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgery--Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

mechanical ventilation during video-assisted surgery

Intervention Type PROCEDURE

observed variation of ventilatory parameters during video-assisted surgery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

mechanical ventilation during video-assisted surgery

observed variation of ventilatory parameters during video-assisted surgery

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients who underwent video-assisted surgery by either classic laparoscopy or robotic-assisted surgery.

Exclusion Criteria

* refusal to participate
* conversion of surgery to laparotomy
* need of vasopressure support
* preoperative severe respiratory dysfunction
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Institutul Clinic Fundeni

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Popescu Mihai

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dana Tomescu, Prof

Role: STUDY_CHAIR

Fundeni Clinical Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fundeni Clinical Institute

Bucharest, , Romania

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Romania

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RAS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.