Evaluating Adult Patient Temperatures During Lower Spinal Surgery
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|ClinicalTrials.gov Identifier: NCT03050775|
Recruitment Status : Completed
First Posted : February 13, 2017
Results First Posted : May 7, 2018
Last Update Posted : May 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hypothermia||Device: Heated Ventilator Circuit Device: Standard Ventilator Circuit||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||randomized, trial (treatment or no treatment)|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||Patients were randomly assigned to either the treatment group or the control group prior to surgery. Group randomization was performed using a randomization schedule prepared by the Division of Clinical Statistics with patients randomized in blocks of four. For consented and enrolled patients on the day of surgery in the admit areas, a participant was assigned the next sequential participant ID number and the appropriate sealed envelope was opened to reveal the participant's randomized intervention. This occurred before the patient was transferred to the operating suite. Individuals who performed data analysis were blinded to treatment group.|
|Official Title:||Comparing Patient Temperatures in Adults During Lower Spinal Surgery Using Either a Heated Ventilator Circuit or a Standard Ventilator Circuit With a Heat-Moisture Exchanger|
|Actual Study Start Date :||August 28, 2015|
|Actual Primary Completion Date :||February 5, 2017|
|Actual Study Completion Date :||February 5, 2017|
Experimental: Heated Ventilator Circuit
Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management.
Device: Heated Ventilator Circuit
active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger
Other Name: ANAPOD™ Heat and Humidification System
Active Comparator: Standard Ventilator Circuit
Standard ventilation and temperature management.
Device: Standard Ventilator Circuit
no active heat and humidification during anesthesia
Other Name: Thermovent 600; Portex
- Core Body Temperature [ Time Frame: Approximately four hours post-induction of general anesthesia (or last recorded temperature) ]Core body temperature will be taken in the esophagus. The last recorded esophageal temperature will be used for surgeries not reaching 3 hours duration.
- Intraoperative Core Temperatures Post-induction [ Time Frame: Approximately 30 minutes, 60 minutes, 120 minutes post-induction of general anesthesia ]Core body temperature will be taken in the esophagus after general anesthesia induction.
- Number of Subjects With Post-operative Shivering [ Time Frame: Approximately 2 hours after completion of the surgery ]Shivering in the post-anesthesia care unit will be assessed using the Bedside Shivering Assessment Scale. This is a 4 point scale and rate shivering as the following: absent, mild, moderate, or severe. Only the highest degree of patient shivering was used in the analysis.
- Hospital Length of Stay [ Time Frame: Surgery to hospital discharge ]Number of days in the hospital
- Overall Post-operative Temperature [ Time Frame: PACU arrival ]Temperature at Post Anesthesia Care Unit (PACU) arrival.
- Number of Participants With Transfusion Within 48 Hours of Surgery [ Time Frame: Within 48 hours of surgery ]Requirement of blood transfusion within 48 hours of surgery
- Estimated Blood Loss [ Time Frame: duration of surgery ]The estimated blood loss per case was determined by the anesthesia provider by measuring the volume of blood in the suction canister while taking into account the amount of irrigation solution used.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050775
|Principal Investigator:||Jean M Guyer, DNP||Mayo Clinic|