- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01749436
Role of Lung Ultrasound Imaging for Intraoperative Monitoring of Atelectasis During Laparoscopic Surgery
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
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H2L 4M1
- Centre Hospitalier de l'Université de Montréal (CHUM)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Lung ultrasound imaging
Lung ultrasound imaging examinations performed during the perioperative period for the monitoring of atelectasis associated with laparoscopic surgery
|
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
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
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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