Role of Lung Ultrasound Imaging for Intraoperative Monitoring of Atelectasis During Laparoscopic Surgery
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Atelectasis |
Other: Lung ultrasound imaging examinations |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Role of Lung Ultrasound Imaging for Intraoperative Monitoring of Atelectasis During Laparoscopic Surgery |
- Lung aeration [ Time Frame: From arrival in the operating theatre to immediately before discharge from the recovery room (Day 0) ] [ Designated as safety issue: Yes ]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)
- Gas exchange [ Time Frame: From 5 minutes following induction of anesthesia to immediately before discharge from the recovery room (Day 0) ] [ Designated as safety issue: Yes ]Assess the impact of the different stages of anesthesia and surgery on gas exchange by measuring arterial blood gases.
- Diaphragmatic function [ Time Frame: On arrival in the operating theatre and immediately before discharge from the recovery room (Day 0) ] [ Designated as safety issue: Yes ]Assess diaphragmatic function by ultrasound imaging
- Incidence of pneumothorax [ Time Frame: From 5 minutes following induction of anesthesia to immediately before discharge from the recovery room (Day 0) ] [ Designated as safety issue: Yes ]Estimate the incidence of pneumothorax by ultrasound imaging
- Incidence of endobronchial intubation [ Time Frame: From 5 minutes following induction of anesthesia to immediately before discharge from the recovery room (Day 0) ] [ Designated as safety issue: Yes ]Estimate the incidence endobronchial intubation by ultrasound imaging
| Estimated Enrollment: | 30 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients scheduled for laparoscopic surgery
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
Contacts and Locations| Contact: Martin Girard, MD, FRCPC | 514-890-8000 ext 26876 | martin.girard@mail.mcgill.ca |
| Contact: François Girard, MD,FRCPC | 514-890-8000 ext 26876 | francois.girard.chum@ssss.gouv.qc.ca |
| Canada, Quebec | |
| Centre Hospitalier de l'Université de Montréal (CHUM) | Recruiting |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Contact: Martin Girard, MD, FRCPC 514-890-8000 ext 26876 martin.girard@mail.mcgill.ca | |
| Contact: Monique Ruel, RN, CCRP 514-890-8000 ext 24542 monique.m.ruel.chum@ssss.gouv.qc.ca | |
| Sub-Investigator: Audrey Monastesse, MD | |
| Sub-Investigator: François Girard, MD, FRCPC | |
| Sub-Investigator: Nathalie Massicotte, MD, FRCPC | |
| Sub-Investigator: Sandra Larrivée, MSc | |
| Sub-Investigator: Carl Chartrand-Lefebvre, MD, FRCPC | |
| Principal Investigator: | Martin Girard, MD, FRCPC | Centre hospitalier de l'Université de Montréal (CHUM) |
More Information
No publications provided
| Responsible Party: | Centre hospitalier de l'Université de Montréal (CHUM) |
| ClinicalTrials.gov Identifier: | NCT01749436 History of Changes |
| Other Study ID Numbers: | MG2012-001 |
| Study First Received: | December 12, 2012 |
| Last Updated: | April 30, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
|
Atelectasis Pneumoperitoneum Hypoxemia |
Additional relevant MeSH terms:
|
Pulmonary Atelectasis Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 21, 2013