Evaluation of Ventilatory Strategies During Laparoscopic Surgery

Pneumonia Clinical Trial

Official title:

Re-expansion of Atelectasis During Laparoscopic Surgery. Recruitment Maneuver vs Positive End-expiratory Pressure: a Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01923038
• Other study ID #: BCB232
• Secondary ID: MariaVittoria Ho
• Status: Completed
• Phase: N/A
• First received: May 17, 2013
• Last updated: January 17, 2014
• Start date: November 2012
• Est. completion date: August 2013

Study information

• Verified date: January 2014
• Source: Maria Vittoria Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Atelectasis involving declive areas often occurs during general anesthesia and may persist postoperatively. This phenomenon could be amplified by pneumoperitoneum and Trendelenburg position. Hypothesis: To evaluate whether the shape of the airway pressure-time curve, Stress Index (SI), during constant flow inflation can lead ventilator setting during general anesthesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• American Society Anesthesiology (ASA) I, II;

• age > 18 years;

• elective surgery

Exclusion Criteria:

• ASA III, IV;

• Age < 18 years;

• emergency surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia

Intervention

Procedure:
• First arm: patients ventilated with zero end expiratory pressure

• Patients ventilated with Positive End Expiratory Pressure

• Patients ventilated with Positive End Expiratory Pressure plus Recruitment maneuver

Locations

Country	Name	City	State
Italy	Maria Vittoria Hospital	Turin

Sponsors (1)

Lead Sponsor	Collaborator
Maria Vittoria Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood gases		Continuous evaluation during the time of surgery	Yes
Primary	Pulmonary Stress Index		Continuous evaluation during time of surgery. Partecipants will be followed for the duration of hospital stay, an expected average of 1 weeks	Yes
Secondary	Cardiac Index		Continuous evaluation during the time of surgery	Yes