NCT02616653

Brief Summary

This study is designed to determine the frequency of Tuffier's line overestimation (2 lumbar levels or more) when the palpation method is used in obese parturients at term in the lateral position compared to the sitting position. Hypothesis: The L3-L4 intervertebral space identified by the palpation method will be two levels higher than the level determined by ultrasonography (US) more often in the lateral than in the sitting position.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable pregnancy

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 30, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 3, 2017

Status Verified

February 1, 2017

Enrollment Period

1.1 years

First QC Date

November 25, 2015

Last Update Submit

February 28, 2017

Conditions

PregnancyObesityObstetrical Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Estimation of Tuffier's line using the palpation method

    Incidence of overestimation of the Tuffier's line (2 lumbar levels or more) using the palpation method in the sitting position compared to the lateral position

    On Day one during medical appointment at the obstetrics clinic

Secondary Outcomes (2)

  • Impact of fundal height on estimation of the Tuffier's line using the palpation method

    On Day one during medical appointment at the obstetrics clinic

  • Comfort level using a verbal rating scale

    On Day one during medical appointment at the obstetrics clinic

Study Arms (2)

Sitting followed by lateral position

ACTIVE COMPARATOR

First half of participants will be assigned to have their L3-L4 intervertebral space located first in the sitting position followed by the lateral position using the palpation method confirmed by US. (L3-L4 location: Palpation method confirmed by US)

Procedure: L3-L4 location: Palpation method confirmed by US

Lateral followed by sitting position

ACTIVE COMPARATOR

Second half of participants will be assigned to have their L3-L4 intervertebral space located first in the lateral position followed by the sitting position using the palpation method confirmed by US. (L3-L4 location: Palpation method confirmed by US)

Procedure: L3-L4 location: Palpation method confirmed by US

Interventions

L3-L4 location: Palpation method confirmed by USPROCEDURE

An anesthesiologist will locate the L3-L4 space using the palpation method (Tuffier's line). An investigator trained in US imaging will proceed to the US exam of the spine specifically aiming to identify the L3-L4 intervertebral space. The investigator will note if the same level was identified and if not, which one was according to the US exam.

Lateral followed by sitting positionSitting followed by lateral position

Eligibility Criteria

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

You may qualify if:

  • Obese pregnant women (BMI equal or superior to 30)
  • Pregnancy at term (37 weeks or more)

You may not qualify if:

  • American Society of Anesthesiologists' physical status of 4 or 5
  • Scoliosis or any other anomaly of the spine
  • Prior spine surgery
  • Inability to assume the correct position due to back pain
  • Inability to collaborate
  • Labouring women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2L4M1, Canada

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Sebastien Garneau, MD

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2015

First Posted

November 30, 2015

Study Start

January 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

March 3, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)