NCT02416557

Brief Summary

Intraoperative hypothermia is associated with many clinical adverse outcomes. Many techniques were applied to prevent intraoperative hypothermia, and positive end-expiratory pressure (PEEP) has been known to blunt intraoperative hypothermia by increasing thermoregulatory vasoconstriction threshold. The investigators assessed the effect of PEEP on the prevention of intraoperative hypothermia during spine surgery in prone position.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

April 6, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed
16 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

2 years

First QC Date

April 6, 2015

Last Update Submit

April 9, 2015

Conditions

Spinal Diseases

Outcome Measures

Primary Outcomes (1)

  • Body temperature as assessed by esophageal temperature probe

    Body temperature is assessed by esophageal temperature probe. The investigators used body temperature at 180 minutes after anesthesia induction as a primary outcome

    180 minutes after the completion of anesthesia induction

Secondary Outcomes (1)

  • Thermoregulatory vasoconstriction threshold

    until 180 minutes after the completion of anesthesia induction

Study Arms (2)

Group P

EXPERIMENTAL

Patients using positive end-expiratory pressure (PEEP) of 10 cmH2O (centimeter of water) intraoperatively

Procedure: PEEP

Group C

NO INTERVENTION

Patients using no positive end-expiratory pressure (zero PEEP) intraoperatively

Interventions

PEEPPROCEDURE

application of 10 cmH2O (centimeter of water) positive end expiratory pressure during mechanical ventilation

Also known as: positive end expiratory pressure
Group P

Eligibility Criteria

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

You may qualify if:

  • Patients who were scheduled for elective spine surgery requiring more than 3 hours

You may not qualify if:

  • Patients who do not agree to the study
  • Patients with or American Society of Anesthesiologists (ASA) physical status class 3 or more
  • Patients with thyroid disease, peripheral vascular diseases, uncontrolled diabetes or hypertension
  • Patients with morbid obesity (BMI \>35 kg/m2)
  • Patients with clinically severe pulmonary disease
  • Patients undergoing simultaneous anterior and posterior lumbar fusion surgery were also excluded.
  • Patients with taking non-steroidal anti-inflammatory drug within two weeks
  • Patients with preoperative fever or hypothermia
  • Patients with intraoperative intentional hypothermia for neuroprotection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University of Hospital

Seoul, 110-799, South Korea

Location

Related Publications (3)

  • Yamasaki H, Tanaka K, Funai Y, Suehiro K, Ikenaga K, Mori T, Osugi H, Nishikawa K. The impact of intraoperative hypothermia on early postoperative adverse events after radical esophagectomy for cancer: a retrospective cohort study. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):943-7. doi: 10.1053/j.jvca.2014.02.013.

    PMID: 25107714BACKGROUND

  • Nakajima Y, Mizobe T, Takamata A, Tanaka Y. Baroreflex modulation of peripheral vasoconstriction during progressive hypothermia in anesthetized humans. Am J Physiol Regul Integr Comp Physiol. 2000 Oct;279(4):R1430-6. doi: 10.1152/ajpregu.2000.279.4.R1430.

    PMID: 11004013BACKGROUND

  • Jung KT, Kim SH, Lee HY, Jung JD, Yu BS, Lim KJ, So KY, Lee JY, An TH. Effect on thermoregulatory responses in patients undergoing a tympanoplasty in accordance to the anesthetic techniques during PEEP: a comparison between inhalation anesthesia with desflurane and TIVA. Korean J Anesthesiol. 2014 Jul;67(1):32-7. doi: 10.4097/kjae.2014.67.1.32. Epub 2014 Jul 29.

    PMID: 25097736BACKGROUND

MeSH Terms

Conditions

Spinal Diseases

Interventions

Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Central Study Contacts

Hee Pyung Park, MD PhD

CONTACT

82-2-2072-2466hppark@snu.ac.kr

Hyungseok Seo, MD

CONTACT

82-2072-2469seohyungseok@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2015

First Posted

April 15, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2017

Study Completion

July 1, 2017

Last Updated

April 15, 2015

Record last verified: 2015-04

Locations

KR(1)