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Epinephrine

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Dopamine

Dopamine Agonists

Dopamine Agents

Epinephrine, Norepinephrine, Dobutamine, Dopexamine

0.2mcg/kg/min maximum infusion; to increase mean arterial pressure by 30mmHg

Maximum infusion of 0.2mcg/kg/min, to increase mean arterial pressure by 30mmHg

Maximum infusion rate of 8mcg/kg/min to increase mean arterial pressure by 30mmHg

Maximum infusion rate of 5mcg/kg/min to increase mean arterial pressure by 30mmHg

Stephen R Watt-Smith, FDSRCS, MD

Following surgery to remove tumours of the head and neck, patients undergo reconstruction with free flaps - tissue that is taken from elsewhere in the body and given a new blood supply by attaching it to vessels in the neck. Following this type of surgery, patients often need medication to maintain their blood pressure in the intensive care unit. The effect of these drugs on the transplanted tissues is unknown. This study investigates the effects of four commonly used drugs on free flap perfusion.

The optimal sympathomimetic drug to support blood pressure without adverse vasoconstriction of free flap circulation remains unknown. This study examined the effects of four agents (epinephrine, norepinephrine, dobutamine and dopexamine) on free flaps following resection of head and neck cancer.

Twenty five patients were recruited to the study. Each patient received an infusion of the four drugs in a random order with an intervening washout period between drugs, at four infusion rates. Continuous free flap skin blood flow monitoring was performed using laser Doppler velocimetry, with a second sensor on normal skin acting as a control. Global cardiovascular variables were monitored using the LiDCO Rapid pulse contour analysis system.

Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery

An Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery: A Randomised Study

Oxford University Hospitals NHS Trust

Mr SR Watt-Smith

Symptoms and General Pathology

Fistula

Subjects will be permitted to drink liquids by mouth on the first day after surgery. Outcomes related to their care, wound healing, and quality of life will be followed for 30 days after surgery.

Early Feeding

Rocco Ferrandino, MD

Catharine Kappauf, MD

Mohemmed Khan, MD

This is a prospective single-arm non-inferiority trial evaluating surgical outcomes in subjects who are fed in the first days after oral cavity reconstructive surgery. The purpose of the study is to specifically compare the rates of orocutaneous fistula in subjects who are allowed to eat immediately after surgery to those rates published in the literature (individuals for whom oral feeding is delayed for several days after surgery). Eighty nine subjects who will undergo oral cavity reconstructive surgery will be enrolled between Mount Sinai Hospital and Mount Sinai West. Study participation will last for 30 days after surgery during which time patients will be examined for any signs or symptoms of surgical site infection or wound breakdown, have several clinical evaluations of swallow function, and be asked to report on several patient reported outcome measures.

In this single-arm non-inferiority study, the study team will aim to evaluate the safety of early feeding in patients with oral cavity reconstruction who are allowed to eat by mouth on post-operative day 1. Traditionally, surgeons have opted to delay the time to oral feeding in oral cavity reconstruction because of concern that an early oral diet may stress intraoral suture lines and lead to the development of salivary leaks. However, evidence from small studies evaluating oral feeding timing in patients who underwent total laryngectomy suggests that there is no increased risk associated with early oral feeding. As such, the study team will aim to determine whether early feeding on postoperative day 1 is non-inferior with respect to the development of orocutaneous fistula to the standard care as described in the literature. There are roughly 50-60 oral cavity reconstructive surgeries performed at Mount Sinai each year - as such it is not feasible to recruit two study arms for direct comparison.

In addition to salivary leak rates, the study team will report outcomes related to the cohort's wound healing, length of time in the hospital, length of time requiring an enteral tube feeds, swallow evaluation information, and the results of patient reported outcomes measures.

The study is a single arm non-inferiority study evaluating wound healing outcomes (orocutaneous fistula, salivary leak, wound dehiscence) in subjects undergoing free tissue transfer for oral cavity reconstruction who are permitted to drink liquids by mouth on postoperative day 1. Outcomes are tracked and assessed over a 30 day period postoperatively.

Early Feeding After Oral Cavity Reconstruction

Early Feeding After Free Flap Reconstruction of Oral Cavity Defects: A Single Arm Non-inferiority Trial

Orocutaneous Salivary Fistula Formation - An orocutaneous fistula or salivary leak is a wound complication that results when saliva or other liquids leak from the mouth through the skin of the face or neck. The subject's oral cavity and neck will be monitored in the standard fashion for development of orocutaneous fistula. The oral cavity will be monitored daily for signs of wound breakdown. The neck will be examined for redness, tenderness to palpation, or increased swelling. Additionally, systemic signs of fistula formation will be monitored such as leukocytosis and fever.

Surgical site infection is defined clinically as fever, erythema, swelling or purulent drainage from the surgical site requiring topical or systemic treatment.

Wound dehiscence is defined as the breakdown at the surgical site with or without intervention.

The proportion of patients that are cleared for a diet by the speech language pathology team.

Aspiration pneumonia is defined clinically based on vital signs, respiratory secretions, and chest x-ray findings indicating pneumonia requiring antibiotic treatment.

Length of hospital stay is defined as the days from admission to discharge.

Bedside swallow evaluation outcomes include jaw Jaw Range of Motion opening which will be measured in millimeters using the Therabite measuring tool and fingers, ranges from 0, indicating \<1, to 5, indicating 3 or greater.

Bedside swallow evaluation outcomes include tongue range of motion. Tongue Range of Motion Scale will be measured in millimeters, with a range of 100-0, 100 indicating full tongue range of motion and 0 indication no tongue movement.

MD Anderson Dysphagia Index (MDADI) is a survey designed to assess a subject's perception of his or her swallowing ability. Patient responds to questionnaire that best reflects their current experience, ranges from Strongly Agree to Strongly Disagree. The scores range from a minimum of 0 to a max of 100, with higher scores indicating higher functioning.

Performance Status Scale for Head and Neck Cancer (PSS-HN) is a survey aimed at evaluating performance and function with regard to eating, speaking, and eating in public. Subscales provide a range of 100 - No restrictions and full understandability to 0 - Full restrictions and no understandability. Subscales are scored individually with higher scores indicating better performance.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery	NCT01418118	Oral Cancer Head and Neck C... Free Flap Hypotension	Epinephrine Norepinephrine Dobutamine Dopexamine	17 Years -	Oxford University Hospitals NHS Trust
Early Feeding After Oral Cavity Reconstruction	NCT04787939	Head and Neck C... Free Tissue Tra...	Early Feeding	18 Years -	Icahn School of Medicine at Mount Sinai
Early Feeding After Oral Cavity Reconstruction	NCT04787939	Head and Neck C... Free Tissue Tra...	Early Feeding	18 Years -	Icahn School of Medicine at Mount Sinai

Spots Global Cancer Trial Database for free tissue transfer