Effects of Video-Assisted Surgery on Ventilatory Parameters

Surgery--Complications Clinical Trial

Official title:

Effects of Pneumoperitoneum on Ventilatory Parameters in Patients Undergoing Video-assisted Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04513262
• Other study ID #: RAS
• Status: Completed
• Start date: March 20, 2015
• Est. completion date: November 10, 2018

Study information

• Verified date: August 2020
• Source: Institutul Clinic Fundeni
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 10, 2018
• Est. primary completion date: November 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgery--Complications

Intervention

Procedure:
• mechanical ventilation during video-assisted surgery
observed variation of ventilatory parameters during video-assisted surgery

Locations

Country	Name	City	State
Romania	Fundeni Clinical Institute	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
Institutul Clinic Fundeni

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one-hour and two-hours after induction of pneumoperitoneum
Secondary	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.	one-hour and two-hours after induction of pneumoperitoneum