NCT03026530

Brief Summary

The purpose of this prospective, blinded, randomized clinical trial is to investigate whether a ventilator-piloted PRM at the end of laparoscopic bariatric surgery could reduce overall postoperative pain and nausea.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

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

Study Start

First participant enrolled

November 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

December 5, 2018

Completed
Last Updated

December 5, 2018

Status Verified

December 1, 2018

Enrollment Period

1.5 years

First QC Date

January 12, 2017

Results QC Date

September 3, 2018

Last Update Submit

December 4, 2018

Conditions

Pain, PostoperativePostoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain

    A questionnaire with a numeric rating scale (NRS) is used to evaluate pain intensity at 4, 12, 24, 36 and 48 hours postoperatively to assess pain intensity. The scale includes even numbers from 0 to 10, where 0 signifies no pain, and 10 signifies the worst imaginable pain.

    4, 12, 24, 36 and 48 hours after surgery

Secondary Outcomes (1)

  • Postoperative Nausea

    4, 12, 24, 36 and 48 hours after surgery

Study Arms (2)

Pulmonary recruitment maneuver

EXPERIMENTAL

Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery.

Procedure: Pulmonary recruitment maneuverProcedure: Laparoscopic bariatric surgeryDevice: Ventilator

Control group

ACTIVE COMPARATOR

Ordinary ventilation at the end of laparoscopic bariatric surgery.

Procedure: Laparoscopic bariatric surgeryDevice: Ventilator

Interventions

Pulmonary recruitment maneuverPROCEDURE

The participants in the experimental arm receives 1 minute of ventilator-piloted pulmonary recruitment with positive inspiratory pressure set to 40 cm H2O, at the end of laparoscopic bariatric surgery.

Pulmonary recruitment maneuver
Laparoscopic bariatric surgeryPROCEDURE
Control groupPulmonary recruitment maneuver
VentilatorDEVICE
Control groupPulmonary recruitment maneuver

Eligibility Criteria

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

You may qualify if:

  • elective laparoscopic bariatric surgery (LBS)
  • American Society of Anaesthesiologists (ASA) physical status classification I-II (with the exception of body mass index over 35 kg/m2)
  • written consent

You may not qualify if:

  • conversion to open surgery
  • complication, Clavien-Dindo grade ≥ II

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Pasquier EK, Andersson E. Pulmonary recruitment maneuver reduces pain after laparoscopic bariatric surgery: a randomized controlled clinical trial. Surg Obes Relat Dis. 2018 Mar;14(3):386-392. doi: 10.1016/j.soard.2017.11.017. Epub 2017 Nov 22.

    PMID: 29290563RESULT

MeSH Terms

Conditions

Pain, PostoperativePostoperative Nausea and Vomiting

Interventions

Ventilators, Mechanical

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNauseaSigns and Symptoms, DigestiveVomiting

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Results Point of Contact

Title
Dr. Kihlstedt Pasquier
Organization
Region Ostergotland
ebba.kihlstedt.pasquier@regionostergotland.se
0046101041000

Study Officials

  • Ebba Kihlstedt Pasquier, MD

    Vrinnevi Hospital, Norrköping, Sweden

    PRINCIPAL INVESTIGATOR

  • Ellen Andersson, MD, PhD

    Vrinnevi Hospital, Norrköping, Sweden

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2017

First Posted

January 20, 2017

Study Start

November 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

December 5, 2018

Results First Posted

December 5, 2018

Record last verified: 2018-12