The Effects of a Head Elevated Ramped Position During Elective Cesarean Delivery After Combined Spinal Epidural (CSE) Anesthesia

This study has been completed.
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01161693
First received: July 12, 2010
Last updated: August 9, 2011
Last verified: August 2011
  Purpose

This study will randomly allocate 180 women undergoing elective C-sections under combined spinal epidural (CSE) Anesthesia at BC Women's Hospital to one of three groups: Standard Pillow under Head (Control), Head Elevated in Ramped Position immediately after regional anesthesia (HERP), or Head Elevated Ramped Position horizontally- Horizontal until establishment of anesthesia and then head elevated for the surgical procedure (HERP-H). The subjects will be monitored for blood pressure changes (hypotension), comfort levels and time to adequate level of the anesthetic block obtained with the CSE. The study will determine if positioning a parturient in the ramped position using an elevation pillow will significantly increase the time for anesthesia to reach the dermatome level of T4 as well as whether it increases maternal comfort and provides a better airway position for the parturient.


Condition Intervention
Cesarean Section
Device: TROOP® elevation pillow

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of a Head Elevated Ramped Position During Elective Cesarean Delivery After Combined Spinal Epidural (CSE) Anesthesia

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • length of time for anesthetic block to reach T4 [ Time Frame: 11 months ] [ Designated as safety issue: Yes ]
    Our primary outcome is the length of time for anesthetic block to reach T4 from time of subarachnoid injection of local anesthetic, tested with ice


Secondary Outcome Measures:
  • Need for epidural supplementation [ Time Frame: 11 months ] [ Designated as safety issue: Yes ]
    Need for epidural supplementation Maximum block height Maternal comfort Height of Block at 120 minutes Incidence of hypotension and dose of vasopressor used. Optimal head positioning for intubation - External Auditory Meatus/sternal relationship.


Enrollment: 60
Study Start Date: July 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard pillow under head
Control (C) - Standard pillow under head (figure 1) as is the usual practice at BC Women's Hospital
Device: TROOP® elevation pillow
Maternal Comfort after CSE during elective Cesarean Section in relation to adequate height of Anesthetic Block
Active Comparator: Troop Elevation Pillow in horizontal position-HERP
TROOP® elevation pillow (designed by an American bariatric anaesthesiologist Dr Craig Troop, plastic covered foam pillow with an elevation angle of 20 degrees which can simply be placed on the operating table)
Device: TROOP® elevation pillow
designed by an American bariatric anaesthesiologist Dr Craig Troop, plastic covered foam pillow with an elevation angle of 20 degrees which can simply be placed on the operating table
Active Comparator: Troop Elevation Pillow in horizontal position-HERP-H
Operating table tilted in Trendelenberg position so angle of Troop pillow is parallel to floor (figure 3) until establishment of adequate block and then the bed levelled to horizontal i.e. to the same position as group (HERP) (figure 2)
Device: TROOP® elevation pillow
designed by an American bariatric anaesthesiologist Dr Craig Troop, plastic covered foam pillow with an elevation angle of 20 degrees which can simply be placed on the operating table

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnancy greater than 37 weeks gestation
  • ASA (American Society of Anaesthesiologists) I and II classification of health. Class I a normal healthy patient and II a patient with mild systemic disease (i.e. mild asthma)
  • Mothers presenting to the assessment unit with ruptured membranes or in the early stages of labour for whom a vaginal birth was not planned and who are therefore in need of urgent cesarean delivery.
  • Potential subjects need to be able to read and understand English, unless an independent translator is available.

Exclusion Criteria:

  • Women having general anesthesia
  • Mothers in active labour - 3cm or more dilated with regular coordinated contractions (3 in 10 minutes)
  • ASA classification 3 or above
  • Emergency cesarean delivery for fetal heart rate abnormalities
  • Maternal age <19
  • BMI >40. Obesity makes it more difficult to site the combined spinal epidural which could lead to delay in positioning the patient quickly following subarachnoid block. Obesity can result in increased venal caval compression in the supine wedge position causing epidural venous plexus engorgement and dural sac compression which may result in a high block. A later study will look at the effects of positioning in the obese patient
  • Mothers with a history of known tolerance to opioids
  • Uterine over distension- polyhydramnios, twin pregnancy and estimated fetal weight of over 4kg by ultrasound scan -Uterine over distension can result in increased aortocaval compression which may lead to engorgement of the epidural venous plexus and dural sac compression which may result in a high block.
  • Height over 180cm and below 150cm
  • Women presenting for urgent caesarean delivery will be excluded if there is less than 60 minutes between the time that the researcher can approach them regarding the study and the time that they will have their surgery.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01161693

Locations
Canada, British Columbia
BC Women's Hospital, Dept of Anesthesia
Vancouver, British Columbia, Canada, V6H 3N1
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Joanne Douglas, MD, FRCPC University of British Columbia
  More Information

No publications provided

Responsible Party: Joanne Douglas, MD, FRCPC, University of British Columbia, Department of Anesthesia, BC Women's Hospital
ClinicalTrials.gov Identifier: NCT01161693     History of Changes
Other Study ID Numbers: H10-01157
Study First Received: July 12, 2010
Last Updated: August 9, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Cesarean section
spinal anesthesia
CSE
ramped up position
TROOP pillow
elevation pillow
maternal comfort
Maternal Comfort after CSE during elective Cesarean Section in relation to adequate height of Anesthetic Block

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014