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OpenTrials
Completed

NCT Number: NCT01923038

Evaluation of Ventilatory Strategies During Laparoscopic Surgery

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.

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Key information

Conditions

Pneumonia Infections Lung Diseases Pulmonary Atelectasis Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maria Vittoria Hospital

Turin, 10149, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

First arm: patients ventilated with zero end expiratory pressure

Procedure

Patients ventilated with Positive End Expiratory Pressure

Procedure

Patients ventilated with Positive End Expiratory Pressure plus Recruitment maneuver

Procedure

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

Sponsors and collaborators

Lead sponsor

Maria Vittoria Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 14, 2013
Registry last updated
Jan 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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