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Completed

NCT Number: NCT02984657

Reverse Trendelenburg Positioning and Its Effect on Outcomes: 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Elizabeth Youngstown Hospital

Youngstown, Ohio, 44501, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

RTP, reverse Trendelenburg positioning

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

Procedure

RTP, reverse Trendelenburg positioning

Primary outcomes

  1. Postoperative hypoxemia

    Time frame: 48 hours postoperatively

Secondary outcomes

  1. Perioperative pulmonary aspiration

    Time frame: 48 hours postoperatively

Sponsors and collaborators

Lead sponsor

C. Michael Dunham

Other

Collaborators

  • St. Elizabeth Youngstown Hospital

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 7, 2016
Registry last updated
Dec 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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