Role of Lung Ultrasound Imaging for Intraoperative Monitoring of Atelectasis During Laparoscopic Surgery

September 12, 2013 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

General anesthesia results in the development of atelectasis in the dependent areas of the lungs exposing patients to an increased risk of hypoxemia. During laparoscopic procedures, pneumoperitoneum increases already present atelectasis.

Several methods have been suggested to reduce the impact of atelectasis during surgery. However, few intraoperative modalities for the diagnosis and monitoring of atelectasis are available. Lung ultrasound imaging is a promising non-invasive, non-radiant, portable and easy to use tool that as yet to be studied in the intraoperative setting.

This observational study will aim to clarify the role of lung ultrasound imaging during laparoscopic surgery for the diagnostic and monitoring of atelectasis.

This study is designed to:

  • Demonstrate a link between the lung ultrasound aeration score, the partial pressure of oxygen in arterial blood (PaO2) / fraction of inspired oxygen (FiO2) ratio and the oxygenation index.
  • In the event of intraoperative desaturation, study the impact of positive end-expiratory pressure (PEEP) and/or increase of FiO2 on the aeration score.
  • Study the impact of pain on diaphragmatic function and the aeration score.

Our hypothesis is that lung ultrasound imaging allows detection of lung aeration changes associated with induction of general anesthesia, pneumoperitoneum, emergence from anesthesia and changes occurring during the stay in the recovery room.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

On arrival in the operating theatre, each patient will undergo a baseline lung ultrasound examination.

The anesthetic technique and monitoring will be standardized. The radial artery will be cannulated after induction of anesthesia for blood gas monitoring.

Lung ultrasound examinations will be performed 5 minutes following induction of general anesthesia and 5 minutes after insufflation of the abdomen with carbon dioxide. In the event of a desaturation needing an intervention (increase of FiO2 or PEEP), ultrasound imaging will be repeated before and after the intervention. Presence of a pneumothorax or endobronchial intubation will be assessed during each examination. Fifteen minutes after arrival and immediately before discharge from the recovery room, lung ultrasound examinations will also be performed.

FiO2 and vital signs will be recorded at each ultrasound examination. Arterial blood samples will be collected simultaneously. Pain rating using the visual analog scale and diaphragmatic function will be assessed during the preoperative ultrasound examination and before discharge from the recovery room.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • Centre Hospitalier de l'Universite de Montreal (CHUM)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients scheduled for laparoscopic surgery

Description

Inclusion Criteria:

  • Patients aged 18 years and older
  • Scheduled for laparoscopic surgery
  • Physical status 1-3

Exclusion Criteria:

  • Previous thoracic procedure (thoracic drain, thoracotomy, thoracoscopy)
  • Contraindication to the placement of an arterial line
  • Very severe chronic obstructive pulmonary disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Lung ultrasound imaging
Lung ultrasound imaging examinations performed during the perioperative period for the monitoring of atelectasis associated with laparoscopic surgery
Other: Lung ultrasound imaging examinations
Lung ultrasound examinations performed at different time-points immediately before surgery, during surgery under general anesthesia and after surgery in the recovery room to detect and monitor atelectasis related to laparoscopic procedures.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lung aeration
Time Frame: From arrival in the operating theatre to immediately before discharge from the recovery room (Day 0)
Estimate lung aeration by ultrasound imaging using a four point aeration score (0 = normal lung, 1 = moderate aeration loss, 2 = severe aeration loss, 3 = complete aeration loss and consolidation)
From arrival in the operating theatre to immediately before discharge from the recovery room (Day 0)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gas exchange
Time Frame: From 5 minutes following induction of anesthesia to immediately before discharge from the recovery room (Day 0)
Assess the impact of the different stages of anesthesia and surgery on gas exchange by measuring arterial blood gases.
From 5 minutes following induction of anesthesia to immediately before discharge from the recovery room (Day 0)
Diaphragmatic function
Time Frame: On arrival in the operating theatre and immediately before discharge from the recovery room (Day 0)
Assess diaphragmatic function by ultrasound imaging
On arrival in the operating theatre and immediately before discharge from the recovery room (Day 0)
Incidence of pneumothorax
Time Frame: From 5 minutes following induction of anesthesia to immediately before discharge from the recovery room (Day 0)
Estimate the incidence of pneumothorax by ultrasound imaging
From 5 minutes following induction of anesthesia to immediately before discharge from the recovery room (Day 0)
Incidence of endobronchial intubation
Time Frame: From 5 minutes following induction of anesthesia to immediately before discharge from the recovery room (Day 0)
Estimate the incidence endobronchial intubation by ultrasound imaging
From 5 minutes following induction of anesthesia to immediately before discharge from the recovery room (Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MG2012-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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