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

NCT01749436 | Completed

• 1 other identifier: MG2012-001
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atelectasis

Keywords

Atelectasis; Pneumoperitoneum; Hypoxemia

Outcome Measures

Primary Outcomes (1)

• Lung aeration

  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 Outcomes (4)

• Gas exchange

  From 5 minutes following induction of anesthesia to immediately before discharge from the recovery room (Day 0)

• Diaphragmatic function

  On arrival in the operating theatre and immediately before discharge from the recovery room (Day 0)

• Incidence of pneumothorax

  From 5 minutes following induction of anesthesia to immediately before discharge from the recovery room (Day 0)

• Incidence of endobronchial intubation

  From 5 minutes following induction of anesthesia to immediately before discharge from the recovery room (Day 0)

Study Arms (1)

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

Interventions

Lung ultrasound imaging examinations OTHER

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.

Lung ultrasound imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients scheduled for laparoscopic surgery

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Centre de Recherche du Centre Hospitalier de l'Université de Montréal: collaborator

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Pulmonary Atelectasis; Pneumoperitoneum; Hypoxia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Peritoneal Diseases; Digestive System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin Girard, MD, FRCPC

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: December 13, 2012
• Study Start: April 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 16, 2013

Record last verified: 2013-09

Locations

CA (1)