ClinicalTrials.gg
CompletedNCT01923038Updated Jan 20, 2014

Evaluation of Ventilatory Strategies During Laparoscopic Surgery

An interventional study of First arm: patients ventilated with zero end expiratory pressure and Patients ventilated with Positive End Expiratory Pressure in Pneumonia, sponsored by Maria Vittoria Hospital. Completed at 1 site in Italy. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-20.

Sponsored by Maria Vittoria Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Pneumonia

Keywords

  • atelectasis
  • laparoscopic surgery
  • anesthesia
  • mechanical ventilation
  • Prevent
  • shape of the airway
  • pressure-time curve
03

In context

Pneumonia

1,564 studies on the registry are indexed under Pneumonia; 265 are open to participants now.

This study's enrollment of 45 is below the median of 129 across 975 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Maria Vittoria Hospital is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • , IV;
  • Age \< 18 years;
  • emergency surgery
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Active comparator
    Patients ventilated with zero end expiratory pressure (ZEEP)

    patients undergoing gynecologic laparoscopic surgery ventilated at zero end expiratory pressure

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

  • Active comparator
    Patients ventilated with positive end expiratory pressure

    patients undergoing gynecologic laparoscopic surgery ventilated at PEEP

    Procedure: Patients ventilated with Positive End Expiratory Pressure

  • Active comparator
    recruitment plus PEEP

    patients undergoing gynecologic laparoscopic surgery undergoing recruitment plus PEEP

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

Interventions

  • ProcedureFirst arm: patients ventilated with zero end expiratory pressure
  • ProcedurePatients ventilated with Positive End Expiratory Pressure
  • ProcedurePatients ventilated with Positive End Expiratory Pressure plus Recruitment maneuver
06

What researchers measure

Primary outcomes

  1. Pulmonary Stress Index

    Time frame: 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

    Time frame: Continuous evaluation during the time of surgery

Other outcomes

  1. Blood gases

    Time frame: Continuous evaluation during the time of surgery

07

Study locations

1 site
  • Maria Vittoria Hospital
    Turin, 10149, Italy
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2012, a primary completion of Aug 2013 and a completion of Aug 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 17, 2013
First posted
Aug 14, 2013
Start
Nov 2012
Primary completionActual
Aug 2013
CompletionActual
Aug 2013
Last update
Jan 20, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 20, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01923038
Lead sponsor
Maria Vittoria Hospital
Responsible party
Emilpaolo Manno (Emergency Department Director, Maria Vittoria Hospital) — Principal investigator
First posted
Aug 14, 2013
Start date
Nov 2012
Primary completion
Aug 2013
Completion
Aug 2013
Last update
Jan 20, 2014

Study contacts

Emilpaolo Manno, MD
study director · Maria Vittoria Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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