NCT04259918

Brief Summary

Control group: no additional procedure Low ARM group : recruitment maneuver of 30cmH2O High ARM group: recruitment maneuver of 60cmH2O

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Status
unknown

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

January 20, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

February 25, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 19, 2020

Status Verified

February 1, 2020

Enrollment Period

9 months

First QC Date

January 20, 2020

Last Update Submit

February 16, 2020

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (2)

  • numeric rating scale for postoperative pain

    score (0 no pain-10 severe pain)

    up to postoperative 24 hour

  • Quality of recovery (QoR40) for Postoperative comfort

    score 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery)

    up to postoperative 24 hour

Study Arms (3)

Control

EXPERIMENTAL

no applying alveolar recuritment maneuver

Procedure: Alveolar recruitment maneuver

Low ARM

ACTIVE COMPARATOR

Applying 30 cmH2O of alveolar recruitment maneuver 5 times every 5sec

Procedure: Alveolar recruitment maneuver

High ARM

ACTIVE COMPARATOR

Applying 60 cmH2O of alveolar recruitment maneuver 5 times every 5sec

Procedure: Alveolar recruitment maneuver

Interventions

Alveolar recruitment maneuverPROCEDURE

Applying 30 or 60 cmH2O of alveolar recruitment maneuver 5 times every 5 min at the end of bariatric surgery

Also known as: Low pressure alveolar recruitment maneuver, High pressure alveolar recruitment maneuver
ControlHigh ARMLow ARM

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who scheduled for elective bariatric surgery

You may not qualify if:

  • uncontrolled cardio-vascular disease, active pulmonary disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
enrolled groups ares only selected and applied in the operating room and participants, care giver and outcomes accessor could not know the group assignment
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 20, 2020

First Posted

February 7, 2020

Study Start

February 25, 2020

Primary Completion

November 30, 2020

Study Completion

December 31, 2020

Last Updated

February 19, 2020

Record last verified: 2020-02