NCT02037516

Brief Summary

The purpose of this study is to determine if residual weakness after weight loss surgery leads to an increased risk of respiratory complications in the postoperative period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
330

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration 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

Study Start

First participant enrolled

January 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 5, 2016

Status Verified

February 1, 2016

Enrollment Period

2.1 years

First QC Date

January 14, 2014

Last Update Submit

February 4, 2016

Conditions

Respiratory ComplicationMorbid Obesity

Keywords

residual muscle weakness, respiratory events

Outcome Measures

Primary Outcomes (1)

  • Respiratory Events (RE)

    Definition of RE, adapted from Ziemann-Gimmel et. al. f1000research 2012 and Murphy et. al. Anesth Analg 2010;107(1):130-7 Upper airway obstruction requiring an intervention; Hypoxemia despite 3 l/min NC requiring any intervention increasing FiO2 greater than 3 l/min NC tactile stimulation Signs of respiratory distress or impending ventilatory failure; Patient complaining of symptoms of respiratory or upper airway muscle weakness; w or w/o intervention Patient requiring reintubation in the PACU diagnosis of pneumonia on discharge or administration of antibiotics for suspected aspiration pneumonia unplaned application of CPAP/BiPAP unplanned ICU admission for respiratory reasons hypercarbic respiratory failure bag mask ventilation administration of "rescue" reversal after extubation for clinically suspected weakness prolonged intubation and ventilation in PACU and/or in ICU unplanned administration of breathing treatment

    2 years

Study Arms (2)

Control Group

ACTIVE COMPARATOR

qualitative monitoring of neuromuscular paralysis, standard treatment at this facility

Drug: NeostigmineDevice: Qualitative Monitor

Study Group

ACTIVE COMPARATOR

quantitative monitoring of neuromuscular paralysis as described in (Brull Murphy Anesth Analg 2010;111:129-40) Acceleromyography

Device: AccelomyographyDrug: Neostigmine

Interventions

AccelomyographyDEVICE

quantitative measurement of the train-of-four with the TOF Watch to determine timing of administration of neostigmine and extubation To assure patient flow the time to reversal administration will be limited to approximately 30 minutes after achieving 4 twitches in qualitative monitoring

Also known as: TOF watch
Study Group
NeostigmineDRUG

Neostigmine is used to reverse the effects of neuromuscular blocking agents

Control GroupStudy Group
Qualitative MonitorDEVICE

Qualitative (tactile or visual) assessment of residual neuromuscular paralysis

Control Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- All patients scheduled for bariatric surgery at Flagler Hospital will be included after written and informed consent.

You may not qualify if:

  • \- Patients will be excluded from the study if they don't consent to participate in the study. Patients allergic to any of the study medication will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Flagler Hospital

Saint Augustine, Florida, 32086, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Neostigmine

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium Compounds

Study Officials

  • Patrick Ziemann-Gimmel, MD

    Coastal Anesthesiology Consultants

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 14, 2014

First Posted

January 16, 2014

Study Start

January 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

February 5, 2016

Record last verified: 2016-02

Locations

US(1)