Colorectal SurgeryNCT04411186

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

A study testing Standard Enhanced Recovery After Surgery (ERAS) Protocol and ERAS and 5 Lung Protective Interventions in people with Colorectal Surgery and Hepatobiliary Surgery, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Colorectal Surgery, Hepatobiliary Surgery
What is being tested?: Standard Enhanced Recovery After Surgery (ERAS) Protocol and ERAS and 5 Lung Protective Interventions
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 22 Mar 2021to 21 Sep 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical University of South Carolina
Charleston, South Carolina, 29425

Other trials in United States

About this study

Conditions: Colorectal Surgery, Hepatobiliary Surgery
Being tested: Standard Enhanced Recovery After Surgery (ERAS) Protocol, ERAS and 5 Lung Protective Interventions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standard Enhanced Recovery After Surgery (ERAS) ProtocolProcedure or surgery
Subjects receive standard MUSC ERAS protocol - fluid intake, hydration, anti-emetics, pain control, and several other considerations.
ERAS and 5 Lung Protective InterventionsProcedure or surgery
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%

Study groups in NCT04411186
Study group	Role	What they receive
Standard Enhanced Recovery After Surgery (ERAS) Protocol	Active comparator	Control for this study will be the standard MUSC ERAS protocol - fluid intake, hydration, anti-emetics, pain control, and several other considerations. Receives: Procedure: Standard Enhanced Recovery After Surgery (ERAS) Protocol
ERAS and 5 Lung Protective Interventions	Experimental	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: 1. Pressure control ventilation-volume guaranteed (PCV-VG) ventilation at approximately 7cc/kg of predicted body weight (derived from combination of sex and height) 2. Positive end-expiratory pressure (PEEP) 7cm H2O5 3. Immediately post intubation recruitment breath (30cm water for 30 seconds) 4. Every 1 hour recruitment breath (30cm water for 30 seconds) 5. 40% FIO2 initially - titrate up as necessary to maintain SPO2 >94% Receives: Procedure: ERAS and 5 Lung Protective Interventions

What is being measured

The primary outcome is the main question the study is designed to answer.

Inspiratory Capacity
The primary outcome of interest is the inspiratory capacity obtained in the PACU via the incentive spirometer.
Measured: 2 hours

Secondary outcomes (2)

Oxygen Saturation (SPO2) Trends
Numerical value for SPO2 trends in 15 min intervals in the Post Operative Care Unit (PACU)
Measured: 2 hours
Incidence of Supplemental Oxygen Requirements
Recording of use or lack thereof of supplemental oxygen in PACU in 15 minute intervals.
Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Mar 202121 Sep 2021

First posted2 Jun 2020
Study start22 Mar 2021
Primary completion21 Sep 2021
Study completion21 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04411186
Sponsor's protocol ID: Pro00094011
Status last verified: Jul 2024
First submitted: 27 May 2020
Last updated: 5 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Trial of Adding Lung Protective Strategies to Existing Enhanced Recovery After Surgery (ERAS) Protocols and Its Effects on Improving Post-Operative Lung Function
ClinicalTrials.gov ID: NCT04411186
Acronym / sponsor ID: Pro00094011
Conditions: Colorectal Surgery, Hepatobiliary Surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Study start: 22 Mar 2021 (actual)
Primary completion: 21 Sep 2021 (actual)
Study completion: 21 Sep 2021 (actual)
First posted: 2 Jun 2020 (actual)
Results: Posted 5 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Standard Enhanced Recovery After Surgery (ERAS) Protocol	Active comparator	Procedure: Standard Enhanced Recovery After Surgery (ERAS) ProtocolControl for this study will be the standard MUSC ERAS protocol - fluid intake, hydration, anti-emetics, pain control, and several other considerations.
ERAS and 5 Lung Protective Interventions	Experimental	Procedure: ERAS and 5 Lung Protective InterventionsThe 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: 1. Pressure control ventilation-volume guaranteed (PCV-VG) ventilation at approximately 7cc/kg of predicted body weight (derived from combination of sex and height) 2. Positive end-expiratory pressure (PEEP) 7cm H2O5 3. Immediately post intubation recruitment breath (30cm water for 30 seconds) 4. Every 1 hour recruitment breath (30cm water for 30 seconds) 5. 40% FIO2 initially - titrate up as necessary to maintain SPO2 >94%

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Standard Enhanced Recovery After Surgery (ERAS) ProtocolSubjects receive standard MUSC ERAS protocol - fluid intake, hydration, anti-emetics, pain control, and several other considerations.	Procedure or surgery	Standard Enhanced Recovery After Surgery (ERAS) Protocol
ERAS and 5 Lung Protective InterventionsSubjects 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%	Procedure or surgery	ERAS and 5 Lung Protective Interventions

Primary outcome

Inspiratory Capacity
Time frame: 2 hours
The primary outcome of interest is the inspiratory capacity obtained in the PACU via the incentive spirometer.

2 secondary outcomes

Oxygen Saturation (SPO2) Trends
Time frame: 2 hours
Incidence of Supplemental Oxygen Requirements
Time frame: 2 hours

Results and safety

Results posted to the registry on 5 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Enhanced Recovery After Surgery (ERAS) Protocol	50	50
ERAS and 5 Lung Protective Interventions	50	49

Primary outcome: Inspiratory Capacity

Time frame: 2 hours. Mean (Standard Deviation). Unit: mL

Measure	Standard Enhanced Recovery After Surgery (ERAS) Protocol n = 50	ERAS and 5 Lung Protective Interventions n = 49
Preoperative incentive spirometry (average)	2,043.3 (628.4)	2,012.2 (895.2)
Postoperative incentive spirometry 30 min (average)	1,195.2 (715.0)	1,233.3 (894.1)
Postoperative incentive spirometry 1 h (average)	1,313.9 (618.1)	1,387.3 (975.3)
Postoperative incentive spirometry 2 h (average)	1,376.3 (651.2)	1,454.8 (906.4)
Postoperative incentive spirometry total (average)	1,253.5 (593.7)	1,390.4 (964.9)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of consent and enrollment through each patient's completion of the study which was until they leave the PACU, or until two hours has passed, whichever was less.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Enhanced Recovery After Surgery (ERAS) Protocol	0 of 50 (0%)	0 of 50 (0%)	0 of 50
ERAS and 5 Lung Protective Interventions	0 of 49 (0%)	0 of 49 (0%)	0 of 49

Limitations and caveats (from the sponsor): Limitations to the study included difficulties with obtaining all data points during the post-anesthesia care unit (PACU) timeframe, specifically the use of supplemental oxygen in the PACU, therefore fewer conclusions can be drawn without this secondary outcome data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Gutman, MD principal investigator

Medical University of South Carolina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inspiratory Capacity (time frame: 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04411186.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.