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

December 4, 2016 updated by: C. Michael Dunham

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Youngstown, Ohio, United States, 44501
        • St. Elizabeth Youngstown Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Surgical patients from an urban hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
RTP, reverse Trendelenburg positioning
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.
RTP, reverse Trendelenburg positioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative hypoxemia
Time Frame: 48 hours postoperatively
48 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Perioperative pulmonary aspiration
Time Frame: 48 hours postoperatively
48 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

C. Michael Dunham

Collaborators

St. Elizabeth Youngstown Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

December 4, 2016

First Submitted That Met QC Criteria

December 4, 2016

First Posted (ESTIMATE)

December 7, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 7, 2016

Last Update Submitted That Met QC Criteria

December 4, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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