NCT01923038

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
Last Updated

January 20, 2014

Status Verified

January 1, 2014

Enrollment Period

9 months

First QC Date

May 17, 2013

Last Update Submit

January 17, 2014

Conditions

Pneumonia

Keywords

atelectasislaparoscopic surgeryanesthesiamechanical ventilationPreventshape of the airwaypressure-time curve

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Cardiac Index

    Continuous evaluation during the time of surgery

Other Outcomes (1)

  • Blood gases

    Continuous evaluation during the time of surgery

Study Arms (3)

Patients ventilated with zero end expiratory pressure (ZEEP)

ACTIVE COMPARATOR

patients undergoing gynecologic laparoscopic surgery ventilated at zero end expiratory pressure

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

Patients ventilated with positive end expiratory pressure

ACTIVE COMPARATOR

patients undergoing gynecologic laparoscopic surgery ventilated at PEEP

Procedure: Patients ventilated with Positive End Expiratory Pressure

recruitment plus PEEP

ACTIVE COMPARATOR

patients undergoing gynecologic laparoscopic surgery undergoing recruitment plus PEEP

Procedure: Patients ventilated with Positive End Expiratory Pressure plus Recruitment maneuver

Interventions

First arm: patients ventilated with zero end expiratory pressurePROCEDURE
Patients ventilated with zero end expiratory pressure (ZEEP)
Patients ventilated with Positive End Expiratory PressurePROCEDURE
Patients ventilated with positive end expiratory pressure
Patients ventilated with Positive End Expiratory Pressure plus Recruitment maneuverPROCEDURE
recruitment plus PEEP

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society Anesthesiology (ASA) I, II;
  • age \> 18 years;
  • elective surgery

You may not qualify if:

  • ASA III, IV;
  • Age \< 18 years;
  • emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maria Vittoria Hospital

Turin, Turin, 10149, Italy

Location

MeSH Terms

Conditions

PneumoniaPulmonary Atelectasis

Interventions

Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Emilpaolo Manno, MD

    Maria Vittoria Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emergency Department Director

Study Record Dates

First Submitted

May 17, 2013

First Posted

August 14, 2013

Study Start

November 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

January 20, 2014

Record last verified: 2014-01

Locations

IT(1)