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OpenTrials
Completed

NCT Number: NCT04411186

A Trial of Adding Lung Protective Strategies to Existing Enhanced Recovery After Surgery (ERAS) Protocols and Its Effects on Improving Post-Operative Lung Function

The objective of this study is to determine whether the addition of lung protective strategies to existing enhanced recovery after surgery (ERAS) protocols for colorectal surgeries and hepatobiliary surgeries will improve post-operative lung function.

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Key information

Conditions

Colorectal Surgery Hepatobiliary Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • All subjects going for scheduled colorectal or hepatobiliary surgery at the MUSC ART hospital who would normally be utilizing the existing ERAS protocols
  • English speaking
  • Able to give informed consent
  • Ages 18 years and older

Exclusion criteria

  • Emergency cases
  • Pregnant subjects-confirmed by pre-operative urine pregnancy test
  • Subjects with unique lung pathologies including, but not limited to: advanced pulmonary fibrosis, lung transplantation recipients, end stage COPD, pulmonary Hypertension
  • Subjects on home O2

Treatment and study plan

Standard Enhanced Recovery After Surgery (ERAS) Protocol

Procedure

Subjects receive standard MUSC ERAS protocol - fluid intake, hydration, anti-emetics, pain control, and several other considerations.

ERAS and 5 Lung Protective Interventions

Procedure

Subjects will receive the standard MUSC ERAS protocol - fluid intake, hydration, anti-emetics, pain control, and several other considerations. The subject will also receive the following lung protective interventions:

Pressure control ventilation-volume guaranteed (PCV-VG) ventilation at approximately 7cc/kg of predicted body weight (derived from combination of sex and height) Positive end-expiratory pressure (PEEP) 7cm H2O5 Immediately post intubation recruitment breath (30cm water for 30 seconds) Every 1 hour recruitment breath (30cm water for 30 seconds) 40% FIO2 initially - titrate up as necessary to maintain SPO2 >94%

Primary outcomes

  1. Inspiratory Capacity

    Time frame: 2 hours

    The primary outcome of interest is the inspiratory capacity obtained in the PACU via the incentive spirometer.

Secondary outcomes

  1. Oxygen Saturation (SPO2) Trends

    Time frame: 2 hours

    Numerical value for SPO2 trends in 15 min intervals in the Post Operative Care Unit (PACU)

  2. Incidence of Supplemental Oxygen Requirements

    Time frame: 2 hours

    Recording of use or lack thereof of supplemental oxygen in PACU in 15 minute intervals.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 2, 2020
Registry last updated
Jul 5, 2024

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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