Role of Lung Ultrasound Imaging in the Comparison of Two Mechanical Ventilation Strategies During Laparotomy

Atelectasis Clinical Trial

Official title:

Role of Lung Ultrasound Imaging in the Comparison of Two Mechanical Ventilation Strategies During Laparotomy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02055807
• Other study ID #: 13.293
• Status: Completed
• Phase: N/A
• First received: February 3, 2014
• Last updated: January 25, 2016
• Start date: February 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The use of positive end-expiratory pressure (PEEP) and recruitment maneuvers during laparotomy will limit the development of atelectasis and therefore improve the aeration score.

Description:

Postoperative pulmonary complications contribute to the morbidity of surgical patients. During general anesthesia, up to 90% of patients will develop atelectasis, which is thought to be a major contributing factor to their development. The adjustment of ventilator settings to prevent the occurrence of atelectasis and reduce pulmonary complications remains controversial. Despite the use of similar mechanical ventilation strategies, two recent studies (IMPROVE, PROVHILO) involving 1300 patients diverged in their conclusions regarding the impact of these strategies in the prevention of pulmonary complications. In these studies, the absence of imagery to assess the pulmonary end-result of the different ventilation strategies complicates the interpretation of their results.

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. Ventilator settings will be adjusted according to randomization.

A second lung ultrasound examination will be performed 5 minutes following induction of general anesthesia. In the PEEP group, a lung ultrasound examination will be performed immediately following the first recruitment maneuver. A lung ultrasound examination will also be performed at the end of surgery before emergence of general anesthesia.

Fifteen minutes after arrival in the recovery room, a last lung ultrasound examination will be performed. Fraction of inspired oxygen (FiO2) and vital signs will be recorded during each ultrasound examination. Arterial blood samples will be collected simultaneously. The aeration score will be calculated for each lung ultrasound examination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged 18 years and older

• Scheduled for surgery by laparotomy (expected to last at least 2 hours)

• American Society of Anesthesiologists classification: 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atelectasis
• Pulmonary Atelectasis

Intervention

Other:
• PEEP and recruitment maneuvers

• ZEEP (no PEEP nor recruitment maneuver)

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal (CHUM)	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung aeration	Compare lung aeration between two different mechanical ventilation strategies (with or without PEEP and recruitment maneuvers) using ultrasound imaging and a four point aeration score (0 = normal lung, 1 = moderate aeration loss, 2 = severe aeration loss, 3 = complete aeration loss and consolidation).	Post-induction to pre-emergence of anesthesia - Day 0	Yes
Secondary	Re-aeration following recruitment maneuvers	Assess lung re-aeration following a recruitment maneuver by ultrasound imaging (lung aeration score pre/post the first recruitment maneuver during general anesthesia).	Prior and after the first recruitment maneuver during general anesthesia - Day 0	Yes
Secondary	Atelectasis secondary to induction	Estimate development of atelectasis secondary to intubation.	Lung aeration score prior and after intubation - Day 0	Yes
Secondary	Atelectasis secondary to extubation	Estimate development of atelectasis secondary to extubation.	Lung aeration score prior and after extubation - Day 0	Yes