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NCT Number: NCT03551899

Intra-operative Ventilatory Management & Post-operative Pulmonary Complications

Background: The list of studies with inconsistent data regarding the effect of intra-operative ventilatory management on post-operative lung injury is large. The literature is lacking data on the least injurious way of ventilating surgical patients intra-operatively. This study is necessary to support future guidelines on the practice of intra-operative mechanical ventilation.

Specific Aim: The aims of this study is first to describe intra-operative ventilatory practices at the American University of Beirut Medical Center (AUBMC), (with particular focus on the mode of ventilation, tidal volume per body weight and PEEP settings) and second, to identify the post-operative complications that could be associated with particular settings.

Methodology: This is a prospective observational study that will be conducted in the operating room at AUBMC, on patients being admitted for surgeries under general anesthesia. During the patient's stay in the hospital, targeted process (patient characteristics, surgical procedure, mechanical ventilation management, anesthesiologist characteristics) and outcomes parameters (postoperative pulmonary complications) will be collected for analysis. Patients will be monitored and followed up with intraoperatively and postoperatively.

Analysis: Different parameters and outcomes will be collected and by subgrouping the patients per their medical history statistical significance will be tested to reach a correlative analysis to the outcomes documented. Statistical comparison will be made using the ANOVA, Student's t-test, and Chi-squared test. Level of statistical significance will be considered at p<0.05. Mean age, weight, height and BMI of participants in the different groups will be calculated. ANOVA test will be performed to test statistical significance to compare the different means between different subgroups. A two sided P value of less than 0.05 was considered to be significant Significance: The literature is lacking data on the least injurious way of ventilating surgical patients intra-operatively. This study is necessary to support future guidelines on the practice of intra-operative mechanical ventilation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AUBMC, Beirut, Lebanon

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Who can participate

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

Inclusion criteria

  • surgeries undergone under general anesthesia
  • patients above 18 years old
  • patient able to give consent
  • American Society of Anesthesiologists (ASA) = 1 to 4

Exclusion criteria

  • Patients unable to give consent
  • Patients below 18 years old.
  • Surgeries done under spinal anesthesia or local block or under sedation.
  • Patients admitted to Intensive care unit post-operative due to surgical complications.

Treatment and study plan

Different ventilation parameters

Other

mode of ventilation, tidal volume per body weight and PEEP settings

Primary outcomes

  1. Intra-operative surgical procedures

    Time frame: 2 hours

    Type and duration (in minutes) of the surgical procedure

  2. Intra-operative mechanical ventilation management

    Time frame: 2 hours

    Ventilation mode and settings

Secondary outcomes

  1. Post-operative complications that could be associated with particular settings

    Time frame: 1 week

    atelectasis, pneumonia, aspiration, acute respiratory distress syndrome (ARDS)

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Registry information

Official study title

An Observational Study of Intra-operative Ventilatory Management & Post-operative Pulmonary Complications

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 11, 2018
Registry last updated
Apr 12, 2022

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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