NCT02984657

Brief Summary

The purpose of this study is to investigate whether intraoperative reverse Trendelenburg positioning decreases postoperative hypoxemia and perioperative pulmonary aspiration rates.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Shorter than P25 for all trials

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

May 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 7, 2016

Completed
Last Updated

December 7, 2016

Status Verified

December 1, 2016

Enrollment Period

4 months

First QC Date

December 4, 2016

Last Update Submit

December 4, 2016

Conditions

Keywords

HypoxemiaReverse Trendelenburg

Outcome Measures

Primary Outcomes (1)

  • Postoperative hypoxemia

    48 hours postoperatively

Secondary Outcomes (1)

  • Perioperative pulmonary aspiration

    48 hours postoperatively

Study Arms (2)

2012 patients

Surgical patients in 2012 with anesthesia and nursing staff less attuned to intraoperative RTP.

Procedure: Surgical patients in 2012 with anesthesia and nursing staff less attuned to intraoperative RTP.

2015 patients

Surgical patients in 2015 with enhanced anesthesia and nursing staff awareness and use of intraoperative RTP.

Procedure: Surgical patients in 2015 with enhanced anesthesia and nursing staff awareness and use of intraoperative RTP.

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Surgical patients from an urban hospital

You may qualify if:

  • Patients undergoing endotracheal intubation and general anesthesia
  • Age ≥18 years
  • Glasgow Coma Scale score ≥13 (prior to tracheal intubation)
  • American Society of Anesthesiologists classification I-IV
  • Pre-operative pulmonary stability

You may not qualify if:

  • Tracheal intubation prior to emergency department arrival
  • Cardiac and thoracic surgical patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Elizabeth Youngstown Hospital

Youngstown, Ohio, 44501, United States

Location

Related Publications (28)

  • Dunham CM, Hileman BM, Hutchinson AE, Chance EA, Huang GS. Perioperative hypoxemia is common with horizontal positioning during general anesthesia and is associated with major adverse outcomes: a retrospective study of consecutive patients. BMC Anesthesiol. 2014 Jun 9;14:43. doi: 10.1186/1471-2253-14-43. eCollection 2014.

    PMID: 24940115BACKGROUND
  • Cotton BR, Smith G. The lower oesophageal sphincter and anaesthesia. Br J Anaesth. 1984 Jan;56(1):37-46. doi: 10.1093/bja/56.1.37. No abstract available.

    PMID: 6140931BACKGROUND
  • Tiret L, Desmonts JM, Hatton F, Vourc'h G. Complications associated with anaesthesia--a prospective survey in France. Can Anaesth Soc J. 1986 May;33(3 Pt 1):336-44. doi: 10.1007/BF03010747.

    PMID: 3719435BACKGROUND
  • Kozlow JH, Berenholtz SM, Garrett E, Dorman T, Pronovost PJ. Epidemiology and impact of aspiration pneumonia in patients undergoing surgery in Maryland, 1999-2000. Crit Care Med. 2003 Jul;31(7):1930-7. doi: 10.1097/01.CCM.0000069738.73602.5F.

    PMID: 12847385BACKGROUND
  • Kluger MT, Short TG. Aspiration during anaesthesia: a review of 133 cases from the Australian Anaesthetic Incident Monitoring Study (AIMS). Anaesthesia. 1999 Jan;54(1):19-26. doi: 10.1046/j.1365-2044.1999.00642.x.

    PMID: 10209365BACKGROUND
  • Ewig S, Torres A. Prevention and management of ventilator-associated pneumonia. Curr Opin Crit Care. 2002 Feb;8(1):58-69. doi: 10.1097/00075198-200202000-00010.

    PMID: 12205408BACKGROUND
  • Torres A, Serra-Batlles J, Ros E, Piera C, Puig de la Bellacasa J, Cobos A, Lomena F, Rodriguez-Roisin R. Pulmonary aspiration of gastric contents in patients receiving mechanical ventilation: the effect of body position. Ann Intern Med. 1992 Apr 1;116(7):540-3. doi: 10.7326/0003-4819-116-7-540.

    PMID: 1543307BACKGROUND
  • Reali-Forster C, Kolobow T, Giacomini M, Hayashi T, Horiba K, Ferrans VJ. New ultrathin-walled endotracheal tube with a novel laryngeal seal design. Long-term evaluation in sheep. Anesthesiology. 1996 Jan;84(1):162-72; discussion 27A. doi: 10.1097/00000542-199601000-00019.

    PMID: 8572330BACKGROUND
  • Petring OU, Adelhoj B, Jensen BN, Pedersen NO, Lomholt N. Prevention of silent aspiration due to leaks around cuffs of endotracheal tubes. Anesth Analg. 1986 Jul;65(7):777-80.

    PMID: 3717617BACKGROUND
  • Seegobin RD, van Hasselt GL. Aspiration beyond endotracheal cuffs. Can Anaesth Soc J. 1986 May;33(3 Pt 1):273-9. doi: 10.1007/BF03010737.

    PMID: 3719428BACKGROUND
  • Smith G, Ng A. Gastric reflux and pulmonary aspiration in anaesthesia. Minerva Anestesiol. 2003 May;69(5):402-6.

    PMID: 12768174BACKGROUND
  • Ferrer R, Artigas A. Clinical review: non-antibiotic strategies for preventing ventilator-associated pneumonia. Crit Care. 2002 Feb;6(1):45-51. doi: 10.1186/cc1452. Epub 2001 Jan 11.

    PMID: 11940265BACKGROUND
  • Keenan SP, Heyland DK, Jacka MJ, Cook D, Dodek P. Ventilator-associated pneumonia. Prevention, diagnosis, and therapy. Crit Care Clin. 2002 Jan;18(1):107-25. doi: 10.1016/s0749-0704(03)00068-x.

    PMID: 11910725BACKGROUND
  • Koeman M, van der Ven AJ, Ramsay G, Hoepelman IM, Bonten MJ. Ventilator-associated pneumonia: recent issues on pathogenesis, prevention and diagnosis. J Hosp Infect. 2001 Nov;49(3):155-62. doi: 10.1053/jhin.2001.1073. No abstract available.

    PMID: 11716631BACKGROUND
  • Fernandez-Crehuet R, Diaz-Molina C, de Irala J, Martinez-Concha D, Salcedo-Leal I, Masa-Calles J. Nosocomial infection in an intensive-care unit: identification of risk factors. Infect Control Hosp Epidemiol. 1997 Dec;18(12):825-30.

    PMID: 9442407BACKGROUND
  • Drakulovic MB, Torres A, Bauer TT, Nicolas JM, Nogue S, Ferrer M. Supine body position as a risk factor for nosocomial pneumonia in mechanically ventilated patients: a randomised trial. Lancet. 1999 Nov 27;354(9193):1851-8. doi: 10.1016/S0140-6736(98)12251-1.

    PMID: 10584721BACKGROUND
  • Kollef MH. Ventilator-associated pneumonia. A multivariate analysis. JAMA. 1993 Oct 27;270(16):1965-70.

    PMID: 8411554BACKGROUND
  • Institute for Healthcare Improvement: Prevent ventilator-associated pneumonia. Institute for Healthcare Improvement. 2012. http://www.ihi.org/knowledge/Pages/Changes/ImplementtheVentilatorBundle.aspx; Accessed 9 Dec 2013.

    BACKGROUND
  • Blitt CD, Gutman HL, Cohen DD, Weisman H, Dillon JB. "Silent" regurgitation and aspiration during general anesthesia. Anesth Analg. 1970 Sep-Oct;49(5):707-13. No abstract available.

    PMID: 5534428BACKGROUND
  • McEwen DR. Intraoperative positioning of surgical patients. AORN J. 1996 Jun;63(6):1059-63, 1066-79; quiz 1080-6. doi: 10.1016/s0001-2092(06)63293-6.

    PMID: 8771317BACKGROUND
  • Adedeji R, Oragui E, Khan W, Maruthainar N. The importance of correct patient positioning in theatres and implications of mal-positioning. J Perioper Pract. 2010 Apr;20(4):143-7. doi: 10.1177/175045891002000403.

    PMID: 20446625BACKGROUND
  • Smith KA. Positioning principles. An anatomical review. AORN J. 1990 Dec;52(6):1196-202, 1204, 1206-8. doi: 10.1016/s0001-2092(07)69197-2. No abstract available.

    PMID: 2278485BACKGROUND
  • Mulier JP, Dillemans B, Van Cauwenberge S. Impact of the patient's body position on the intraabdominal workspace during laparoscopic surgery. Surg Endosc. 2010 Jun;24(6):1398-402. doi: 10.1007/s00464-009-0785-8. Epub 2010 Jan 7.

    PMID: 20054583BACKGROUND
  • Abdulla S. Pulmonary aspiration in perioperative medicine. Acta Anaesthesiol Belg. 2013;64(1):1-13.

    PMID: 23767172BACKGROUND
  • Engelhardt T, Webster NR. Pulmonary aspiration of gastric contents in anaesthesia. Br J Anaesth. 1999 Sep;83(3):453-60. doi: 10.1093/bja/83.3.453. No abstract available.

    PMID: 10655918BACKGROUND
  • Ng A, Smith G. Gastroesophageal reflux and aspiration of gastric contents in anesthetic practice. Anesth Analg. 2001 Aug;93(2):494-513. doi: 10.1097/00000539-200108000-00050.

    PMID: 11473886BACKGROUND
  • Kalinowski CP, Kirsch JR. Strategies for prophylaxis and treatment for aspiration. Best Pract Res Clin Anaesthesiol. 2004 Dec;18(4):719-37. doi: 10.1016/j.bpa.2004.05.008.

    PMID: 15460555BACKGROUND
  • Michael Dunham C, Hileman BM, Hutchinson AE, Antonaccio T, Chance EA, Huang GS, Szmaj G, Calabro K, Bishop C, Schrickel TT. Evaluation of operating room reverse Trendelenburg positioning and its effect on postoperative hypoxemia, aspiration, and length of stay: a retrospective study of consecutive patients. Perioper Med (Lond). 2017 Aug 22;6:10. doi: 10.1186/s13741-017-0067-2. eCollection 2017.

MeSH Terms

Conditions

Respiratory AspirationHypoxiaDeception

Interventions

Anesthesia

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and SymptomsSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

  • C. Michael Dunham, MD

    St. Elizabeth Youngstown Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Associate, St. Elizabeth Youngstown Hospital

Study Record Dates

First Submitted

December 4, 2016

First Posted

December 7, 2016

Study Start

May 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

December 7, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations