Reverse Trendelenburg Positioning and Its Effect on Outcomes: a Retrospective Study of Consecutive Patients

Hypoxia Clinical Trial

Official title:

Evaluation of Operating Room Reverse Trendelenburg Positioning and Its Effect on Postoperative Hypoxemia, Aspiration, and Length of Stay: a Retrospective Study of Consecutive Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02984657
• Other study ID #: 15-023
• Status: Completed
• Phase: N/A
• First received: December 4, 2016
• Last updated: December 4, 2016
• Start date: May 2015
• Est. completion date: September 2015

Study information

• Verified date: December 2016
• Source: Mercy Health, Ohio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Description:

Intraoperative pulmonary aspiration can cause death and lead to morbidity. In addition, reliable estimates of aspiration rates are uncertain. In part, this ambiguity relates to the lack of prospective data. Relevant studies are retrospective chart reviews or results from voluntary reporting databases. Furthermore, aspiration diagnosis can be imprecise. The finding is certain when there is aspiration of bile or particulate matter from the tracheobronchial tree or there is endoscopic visualization. However, the diagnosis is presumptive when there is intraoperative or postoperative development of a new chest x-ray infiltrate and attendant tachypnea, hypoxia, wheezing, or changes in ventilator airway pressures.

Most patients undergoing general endotracheal anesthesia are in the supine or horizontal position. However, evidence from the literature demonstrates that the supine position in mechanically ventilated patients is a risk for aspiration and ventilator associated pneumonia (VAP). During intensive care unit (ICU) mechanical ventilation, the Institute for Healthcare Improvement recommends elevating the head of the bed to prevent pulmonary aspiration and VAP. Other investigations have shown a profound relationship between horizontal positioning and intra-operative aspiration. There is substantial operating room, ICU, and animal investigative evidence that aspiration occurs despite the presence of a cuffed endotracheal tube. Likewise, previous work by this group showed a 30% perioperative hypoxemia rate, which was significantly associated with horizontal positioning. The post-operative length of hospital stay was 2 days longer with hypoxemia, compared to no hypoxemia (p <0.0001) and this represented a total of 300 additional days for the 2 months of the study.

The purpose of this retrospective study is to repeat the investigation after adopting a recent policy change of 10-degree Reverse Trendelenburg position as the routine for surgical patients, unless deemed inappropriate by either the anesthesiology or operating room nursing staff.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Tracheal intubation prior to emergency department arrival

• Cardiac and thoracic surgical patients

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Aspiration, Respiratory
• Hypoxia
• Perioperative Period
• Respiratory Aspiration
• Supine Position

Intervention

Procedure:
• Surgical patients in 2012 with anesthesia and nursing staff less attuned to intraoperative RTP.
RTP, reverse Trendelenburg positioning
• Surgical patients in 2015 with enhanced anesthesia and nursing staff awareness and use of intraoperative RTP.
RTP, reverse Trendelenburg positioning

Locations

Country	Name	City	State
United States	St. Elizabeth Youngstown Hospital	Youngstown	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
C. Michael Dunham	St. Elizabeth Youngstown Hospital

Country where clinical trial is conducted

United States, 

References & Publications (27)

Abdulla S. Pulmonary aspiration in perioperative medicine. Acta Anaesthesiol Belg. 2013;64(1):1-13. Review. — View Citation

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. — View Citation

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. — View Citation

Cotton BR, Smith G. The lower oesophageal sphincter and anaesthesia. Br J Anaesth. 1984 Jan;56(1):37-46. Review. — View Citation

Drakulovic MB, Torres A, Bauer TT, Nicolas JM, Nogué 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. — View Citation

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. — View Citation

Engelhardt T, Webster NR. Pulmonary aspiration of gastric contents in anaesthesia. Br J Anaesth. 1999 Sep;83(3):453-60. Review. — View Citation

Ewig S, Torres A. Prevention and management of ventilator-associated pneumonia. Curr Opin Crit Care. 2002 Feb;8(1):58-69. Review. — View Citation

Fernández-Crehuet R, Díaz-Molina C, de Irala J, Martínez-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. — View Citation

Ferrer R, Artigas A. Clinical review: non-antibiotic strategies for preventing ventilator-associated pneumonia. Crit Care. 2002 Feb;6(1):45-51. Review. — View Citation

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.

Kalinowski CP, Kirsch JR. Strategies for prophylaxis and treatment for aspiration. Best Pract Res Clin Anaesthesiol. 2004 Dec;18(4):719-37. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Kollef MH. Ventilator-associated pneumonia. A multivariate analysis. JAMA. 1993 Oct 27;270(16):1965-70. — View Citation

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. — View Citation

McEwen DR. Intraoperative positioning of surgical patients. AORN J. 1996 Jun;63(6):1059-63, 1066-79; quiz 1080-6. Review. — View Citation

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. — View Citation

Ng A, Smith G. Gastroesophageal reflux and aspiration of gastric contents in anesthetic practice. Anesth Analg. 2001 Aug;93(2):494-513. Review. — View Citation

Petring OU, Adelhøj 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. — View Citation

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. — View Citation

Seegobin RD, van Hasselt GL. Aspiration beyond endotracheal cuffs. Can Anaesth Soc J. 1986 May;33(3 Pt 1):273-9. — View Citation

Smith G, Ng A. Gastric reflux and pulmonary aspiration in anaesthesia. Minerva Anestesiol. 2003 May;69(5):402-6. Review. — View Citation

Smith KA. Positioning principles. An anatomical review. AORN J. 1990 Dec;52(6):1196-202, 1204, 1206-8. Review. — View Citation

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. — View Citation

Torres A, Serra-Batlles J, Ros E, Piera C, Puig de la Bellacasa J, Cobos A, Lomeña F, Rodríguez-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. — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative hypoxemia		48 hours postoperatively	No
Secondary	Perioperative pulmonary aspiration		48 hours postoperatively	No