NCT02055807

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2014

Completed
12 months until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

10 months

First QC Date

February 3, 2014

Last Update Submit

January 25, 2016

Conditions

Atelectasis

Keywords

AtelectasisUltrasoundRecruitment maneuverPositive end-expiratory pressure

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Re-aeration following recruitment maneuvers

    Prior and after the first recruitment maneuver during general anesthesia - Day 0

  • Atelectasis secondary to induction

    Lung aeration score prior and after intubation - Day 0

  • Atelectasis secondary to extubation

    Lung aeration score prior and after extubation - Day 0

Study Arms (2)

PEEP and recruitment maneuvers

EXPERIMENTAL

A PEEP of 7 cm H2O will be applied starting after intubation until the end of surgery. Recruitment maneuvers (continuous positive pressure of 30 cm H20 for 30 seconds) will be initiated following intubation and repeated every 30 minutes during surgery and immediately prior to extubation. Lung ultrasound examinations will be 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.

Other: PEEP and recruitment maneuvers

ZEEP (Zero end-expiratory pressure)

ACTIVE COMPARATOR

No PEEP nor recruitment maneuvers will be used during surgery. Lung ultrasound examinations will be 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.

Other: ZEEP (no PEEP nor recruitment maneuver)

Interventions

PEEP and recruitment maneuversOTHER
PEEP and recruitment maneuvers
ZEEP (no PEEP nor recruitment maneuver)OTHER
ZEEP (Zero end-expiratory pressure)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2L 4M1, Canada

Location

Related Publications (1)

  • Genereux V, Chasse M, Girard F, Massicotte N, Chartrand-Lefebvre C, Girard M. Effects of positive end-expiratory pressure/recruitment manoeuvres compared with zero end-expiratory pressure on atelectasis during open gynaecological surgery as assessed by ultrasonography: a randomised controlled trial. Br J Anaesth. 2020 Jan;124(1):101-109. doi: 10.1016/j.bja.2019.09.040. Epub 2019 Nov 14.

    PMID: 31733807DERIVED

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Martin Girard, MD, FRCPC

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2014

First Posted

February 5, 2014

Study Start

February 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 26, 2016

Record last verified: 2016-01

Locations

CA(1)