Prevention of Pulmonary Complications Using High Flow With Tracheostomy Interface vs Conventional Oxygen Therapy in Patients After Major Head and Neck Surgery: Randomized Clinical Trial
Phase: NA
Conditions: Pulmonary Disease
Sponsor: University of Florida

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Title 
 
Prevention of Pulmonary Complications using High flow with tracheostomy interface 
vs Conventional Oxygen Therapy in Patients after Major Head and Neck Surgery: 
Randomized Clinical Trial 
 
Investigators 
Primary Investigators 
Faculty PI:  
• Rui Fernandes, MD, DMD, FACS, FRCS 
o Professor, Department of Oral and Maxillofacial Surgery, Division of Head and 
Neck Surgery 
o Associate Chair, Department of Oral and Maxillofacial Surgery 
o Chief, Division of Head and Neck Surgery 
o Program Director, Head and Neck Oncologic Surgery and Microvascular 
Fellowship 
 
Co-Investigators: 
• Ashleigh Weyh MD, DMD, MPH 
o Resident, Oral and Maxillofacial Surgery 
• Anthony Bunnell MD, DMD  
o Assistant Professor Oral and Maxillofacial Surgery 
• Stacey Nedrud MD, DMD 
o Fellow, Head and Neck Oncology and Reconstruction, Oral and Maxillofacial 
Surgery 
       ∙     Michael Abdelmalik, MD 
o Resident, Oral and Maxillofacial Surgery 
 

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Abstract 
Patients undergoing major head and neck surgery, especially those receiving a 
tracheostomy, are at risk for postoperative pulmonary complications.  This is attributed to 
high prevalence of preexisting comorbidities in this population due to smoking, as well as 
the prolonged anesthesia time for these complex surgeries followed by prolonged periods of 
immobilization during recovery.  Current oxygen therapy relies on cool mist delivered via a 
tracheostomy collar, which has been shown to be suboptimal as the airway functions best at 
physiological temperatures with a higher relative humidity than the aerosol mask can 
deliver.  High flow humidified air is a safe and effective way to provide respiratory support, 
but has not been widely utilized after major head and neck surgery to prevent pulmonary 
complications.   The goal of this randomized clinical trial is to evaluate the effectiveness of 
high flow oxygen at preventing postoperative pulmonary complications after major head and 
neck surgery, when compared to conventional oxygen therapy. 
 
 
Background: 
Major head and neck surgery can come with considerable postoperative risk due to 
prolonged surgical procedures and time under anesthesia, that often directly involve the 
airway. Postoperative pulmonary complications are quite common after major head and 
neck surgery, estimated to be around 18.8-47%, and are increased in those requiring 
tracheostomy [1-5].  Head and neck oncology surgical patients are at high risk due to the 
high prevalence of preexisting cardiopulmonary disease, further complicated by a higher 
proportion of smokers [6].  The patients then undergo long surgeries with general 
anesthesia, often followed by prolonged immobilization during their recovery.  The majority 
of these patients also undergo elective tracheostomy for airway protection.  The 
tracheostomy can further increase risk for pulmonary complications, because the it naturally 
bypasses the airways natural physiologic warming and humidification system.  This causes 
pathological changes in the lower airways, including damage to the ciliated tracheal mucosa, 
thickening of airway secretions, and loss or reduction of mucociliary transport [7].  All of 

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these pathological changes can lead to pneumonia.  While not often fatal in this population, 
pneumonia can still result in prolonged length of stay, need for intensive critical care, 
increased use of broad-spectrum antibiotics, and lengthen the time to tracheostomy 
decannulation [4]. 
 
The current standard for oxygen and humidification postoperatively is delivered via cool 
mist from an aerosol tracheostomy collar.  Studies have shown this system is inadequate, as 
humidification delivered at room air causes mucociliary damage, resulting in increased 
airway secretion production and retention.  Ultimately, this can cause serious complications 
like mucous plugging and pneumonia [8].  
 
High flow oxygen therapy (HFOT) delivers heated and humidified oxygen, which has been 
shown to have multiple benefits, the first being able to delivery physiologically optimal 
heated humidification, as well as the ability to deliver positive airway pressure.  By 
mimicking the optimal airway temperature and humidification, patients have less 
respiratory secretions and have improved clearance, preventing infection [9,10].  Positive 
airway pressure has been shown to improve oxygenation via increased end-expiratory lung 
volumes, and is important postoperatively as it can reduce lower airway collapse and 
atelectasis [11].  Meta-analysis of clinical trials, examining prophylactic use of HFOT during 
the immediate postoperative course for other major operations (cardiac, intrathoracic, 
abdominal), and showed a reduction in reintubation and the need to escalate respiratory 
support, when compared to conventional oxygen therapy [13].   
 
Use of high flow after major head and neck surgery is generally unexplored.  To date, only 
one study evaluates use of prophylactic HFOT tracheostomy collar after major head and neck 
surgery. In this small controlled trial (n=20), they concluded that HFOT was safe and feasible 
for this patient population [2]. 
 
 
 

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Research Question 
Among subjects undergoing major head and neck surgery with tracheostomy, does 
perioperative use of HFOT tracheostomy collar, when compared to conventional oxygen 
therapy, result in fewer postoperative pulmonary complications? 
 
Specific Aims 
1. Determine if HFOT tracheostomy is superior to conventional oxygen therapy at 
preventing postoperative complications 
a. Determine the association between HFOT tracheostomy collar and 
postoperative pulmonary complications 
b. Determine the association between HFOT tracheostomy collar and time to 
tracheostomy decannulation 
c. Determine the association between HFOT tracheostomy collar and total length 
of stay after surgery 
Research Plan 
 
Study Design 
• Single center, non-blinded, prospective randomized clinical trial 
Population: 
● 
Inclusion 
○ Patients undergoing major head and neck surgery that includes any neck 
dissection  
■ 
Major head and neck surgery is defined as having a mean length of stay 
of three or more days, based on the diagnosis [14] 
○ Surgery requires an elective tracheostomy for airway protection or 
laryngectomy tube in the case of total laryngectomy 
● 
Exclusion 
○ <18 years of age 

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Study Protocol 
Screening 
• 
Potential participants will be screened for enrollment at their preoperative surgery 
clinic appointments by their surgeon according to established inclusion/exclusion 
criteria.  If the patient meets inclusion criteria, they will be referred to research 
coordinator to determine if patients wishes to participate and to consent the patient 
in person or via phone (see phone script for informed consent). 
o The following procedures will be performed during pre-operative 
consultation by one of the study team physicians.   
o Patient screening using predefined inclusion and exclusion criteria 
o Demographics, medical and medication history 
o Physical exam 
o Vital signs 
o Preoperative imaging is standard of care and ordered on all subjects prior to 
surgery 
o Subjects will be sent for pre-anesthesia testing for evaluation prior to surgery 
 
At this appointment everyone will undergo EKG, chest radiograph, 
basic metabolic panel, complete blood count 
 
This appointment must occur within 1 week from surgery 
o All patients are routinely presented at the University of Florida Jacksonville 
Head and Neck Tumor Board for discussion of diagnosis and ideal treatment 
• 
Consent 
o Once subjects are determined eligible by the physician, they will be referred 
to the study coordinator.  The study coordinator will meet the patient in 
person at the clinic or over the phone to discuss the full study details, and 
details of the study consent, including risks and benefits (see recruitment and 
consent scripts).   

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 
This is so the patients will have time to adequately decide if they would 
like to participate in the study. 
 
If the patient chooses to not participate in the study, they will still 
receive conventional oxygen therapy. 
 
If the patient requests to speak to the treating surgeons about the 
study, they will be contacted separately to discuss the study as well as 
risks vs benefits. 
o Informed consent will be obtained from the patient in person at a pre-
operative clinic appointment, by phone/electronically via REDcap or on the 
day or surgery by the surgeon/resident or trained research coordinator, 
explaining risks and benefits of the study. 
 
A written consent form will be presented to the patient with oral 
explanation from the research staff trained for formal study consent. 
 
Patients will have opportunity to ask questions regarding the study and 
any risks that may be involved. 
Randomization 
• 
Randomization will be assigned by the study coordinator once the patient completes 
the consent process. 
• 
Patients will be divided into three subgroups after enrollment: no free flap, free flap, 
and laryngo-pharyngectomy 
• 
Randomization into COT vs HFOT will be performed based on a block randomization 
scheme, stratified by subgroup- no free flap, free flap, or laryngo-pharyngectomy. 
• 
This system will be used to ensure well-balanced distribution into these three 
subgroups and in the two arms. 
• 
The goal will be to always keep enrollment balanced accordingly to the usual volume 
of no free flap, free flap, or laryngo-pharyngectomy among the two treatment groups. 
• 
The block randomization scheme will be generated by the analyst with the Center for 
Data Solutions at the UF College of Medicine Jacksonville, FL and it will be uploaded 
into REDCap before the data collection.  
 

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Day of Surgery 
• 
If patients missed their preoperative labs and x-rays, the chest x-ray and labs can be 
drawn in the preoperative area the day of surgery 
• 
The consents for surgery and the study will be completed 
o Subjects are allowed to drop from the study at any time.  If they do, they will 
be treated with COT, which is our current standard of care 
Operating Room 
• 
In the operating room, patients will undergo their surgery per normal operating 
protocol.  No patients will be treated differently because of the study. 
• 
At the end of the procedure all patients requiring tracheostomy will have a size 8-0 
cuffed Portex trach placed, the cuff will be deflated within 3 hours of leaving the 
operating room. Total laryngectomy patients will have a laryngectomy tube placed at 
end of procedure. 
• 
The Anesthesia team will be instructed to treat the patients according to their normal 
standard of care for head and neck surgery 
• 
All patients must be extubated prior to leaving the operating room, or else they will 
be dropped from the study  
• 
Subjects will leave the operating room and be transported to the post anesthesia care 
unit for appropriate monitoring prior to being transferred to a progressive floor 
• 
Starting at the PACU, tracheostomy patients will be started on COT or HFOT via 
tracheostomy adapter , , until occlusive capping of the tracheostomy is tolerated. Once 
the trach is capped, patients can be placed on oxygen vis nasal cannula if it is required 
to maintain 02 saturation levels as stated below.. Total  laryngectomy patients will 
remain on  COT or HFOT via trach mask adapter from the time they are in PACU until 
the time they can tolerate HME (heat moisture exchange) use or are discharged from 
the hospital, whichever comes first. 
Oxygen Protocols- COT v HFOT 
• 
The experimental group will receive HFOT at a flow rate of 60 liters per minute, 
maximum concentration of 40%, which will be titrated by bedside nurse to maintain 

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an oxygen saturation of 92% or greater (unless there is a history of COPD and then 
the clinician can recommend >88%) 
• 
The control group will be placed on aerosolized trach mask with humidification, and 
titrated to keep oxygen saturation >92% (unless there is a history of COPD and then 
the clinician can recommend >88%) 
• 
Patients can be temporarily disconnected from the HFOT or COT for short periods (no 
greater than 1 hour three times a day) to allow for toileting, mobilization 
• 
Patients will all be positioned with head of bed at 30 degrees, undergo PRN tracheal 
suctioning, which will be recorded, and encouraged to take deep breaths. 
• 
A tracheostomto nasal cannula oxygen if required to maintain osygen saturations as 
specified above. 
• 
Patient will receive a 1 view chest radiograph at the beginning of postoperative day 4 
• 
Physicians can order chest radiographs more frequently if deemed clinically 
necessary- must document reasons 
Hospital Care 
• 
Care of patients will follow the University of Florida Jacksonville’s standardized head 
and neck protocol (Figure 1) 
• 
Analgesia management will be standardized: 
o Scheduled 
 
Ibuprofen 600 mg q6 hours scheduled for 72 hours 
 
Acetaminophen 650 mg q6 hours scheduled 
 
Methocarbamol (Robaxin): 500 mg q 8 hours scheduled 
 
Gabapentin 300 mg TID--can scale up if needed to 600 TID after 2 days 
o PRN 
 
Oxycodone 5-10 mg q4-6 hours PRN 
o Breakthrough/PRN:  
 
Morphine 1-4 mg IV q 2-4 hours PRN 
 
Hydromorphone 0.5-1 mg IV q 2-4 hours PRN 

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• 
Fluids will be standardized to prevent fluid overload/pulmonary edema, and ordered 
based on body weight, and ideal body weight for obese patients.  Fluids will be 
discontinued once the patient is taking adequate intake by mouth or via tube feeds 
• 
Weaning of the tracheostomy will be standardized  
o If patient is deemed clinically acceptable by team (no sign of pulmonary 
complication as defined above), the tracheostomy will be downsized on 
postoperative day 4, to a 6-0 fenestrated uncuffed Shiley, and will undergo 
occlusive capping as soon as tolerated after the downsize 
o Once the patient tolerates 24-hour capping, and deemed clinically acceptable 
for decannulation, the tracheostomy will be removed 
o Tracheostomy may be determined necessary if capping not tolerated, or 
needed for aggressive pulmonary toileting 
• 
Consultation for specialty management of subject comorbidities will be permitted 
Clinic Follow Up Appointments 
• Subjects will follow up in clinic between 1-2 weeks postoperatively from their 
discharge date 
• Vitals and physical exam will be performed, and all subjects will be monitored for 
adverse events 
• Subjects will be closely followed every 1-3 weeks for the first 2 months after surgery 
• At 12 days postoperatively all subjects will be called or evaluated in clinic for the final 
screening for adverse events or pulmonary complications 
 
Potential adverse events that could result in subject withdrawal from the trial: 
• Subjects unable to be extubated in the operating room after surgery 
• Subjects who cannot tolerate COT or HFOT for the specified amount of time each day 
• Subjects with surgical complications requiring significant alteration of the treatment 
plan 
o Subjects requiring a return to the operating room during their admission will 
be excluded, unless it is for a procedure not related to the original surgery 

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occurring after post op day 3, such as a gastrostomy tube or long-term IV 
access. 
• Subjects who do not stay in the hospital for at least 4 days after surgery 
 
Outcome Measures 
● 
Primary 
○ Incidence of post-operative pulmonary complication within 14 days 
after surgery 
■ 
Postoperative pulmonary complication will be defined as 
● 
Atelectasis or infiltrate diagnosed by radiologist on any 
postoperative chest radiograph within first 14 days or discharge 
(whichever occurs first) 
● 
Pneumonia 
○ Diagnosis is suggested by a history of cough, dyspnea, 
pleuritic pain, or acute functional or cognitive decline, 
with abnormal vital signs (e.g., fever, tachycardia) and 
lung examination findings. Diagnosis should be confirmed 
by chest radiography or ultrasonography.”  [15] 
● 
Chronic pulmonary obstructive disease exacerbation 
○ “An event in the natural course of the disease 
characterized by a change in the patient's baseline 
dyspnea, cough, and/or sputum and beyond normal day-
to-day variations, that is acute in onset and may warrant 
a change in regular medication in a patient with 
underlying COPD” [16] 
● 
Adult respiratory distress syndrome (Berlin definition) 
● 
Need for reintubation/mechanical ventilation 
● 
Need for non-invasive mechanical ventilation 
● 
Secondary 
○ Time to tracheostomy decannulation (half days) 

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○ Hospital length of stay after surgery (half days) 
○ Need for antibiotics for pulmonary complication (escalation to broad 
spectrum, addition of a second antibiotic, antibiotics past post-operative day 
7) 
○ Need for pulmonary physiotherapy (acapella, flutter, etc.) 
○ Discharge destination: Home vs nursing facility vs rehabilitation 
 
Data Collection 
● 
Data will be recorded in the subject’s medical record list and in their medication 
administration record.  These entries are time stamped at administration.  Research 
data will be collected in REDcap database. 
 
 
 
 
 
 
 
Patient Privacy and Protection 
● 
Identifiable information will be used to monitor clinical records and identify subjects 
for the study.   
● 
Each participant enrolled in the study will be assigned a participant ID number. The 
participant ID number will be used on all forms containing data and information from 
the study.  
● 
Identifiable information (name, date of birth, or MRN) will only be used for data 
acquisition of a master list and all other PHI used of the participants' names and 
participant ID numbers will be kept on an institutional server and on the dedicated 
UF research drive provided by the research department. The master list will be 
retained in a password protected institutional server for 3 years and will then be 

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destroyed per institutional guidelines.  The de-identified data will be retained 
indefinitely in a password protected institutional server.  
● 
Data using the participant ID number will be kept on an institutional server and on 
the dedicated UF research drive  
● 
All data will be stored in REDCap and will later be used for data analysis.   
● 
Consents will be a hard copy and kept in the designated regulatory binder located in 
the study coordinator’s office in a locked cabinet. 
● 
It is possible that your research information, with all personally identifiable 
information removed, could be used for future research studies or distributed to 
another investigator for future research studies without additional informed 
consent from you or your legally authorized representative.  
 
Statistical Analysis 
Sample Size Rationale 
A sample size of 164 patients, 82 in each arm, is sufficient to detect a clinically 
important difference of 20% in the proportion of postoperative pulmonary 
complications between arms using a two-tailed z-test of proportions with 90% power 
and a 5% level of significance. This 20% difference represents 10% of postoperative 
pulmonary complications using HFOT and 30% of postoperative pulmonary 
complications in the control arm. Assuming a 10% rate of withdrawal, we will need 
to recruit 91 patients per arm to be adequately powered to detect the difference. 
An interim analysis of the proportion of postoperative pulmonary complications is planned 
after 100 subjects (50:50) are enrolled to assess whether there will be overwhelming 
evidence of a benefit from HFOT, as compared with conventional oxygen therapy, or of harm 
in any study group. As a consequence, the p-value for the primary comparison between the 
two arms will be adjusted to conserve an overall significance level of 0.05[17].  Descriptive 
summaries will be frequencies and percentages for categorical variables and means, 
standard deviations, medians, and quartiles for continuous variables. The primary analysis 
will compare the difference in the proportion of postoperative pulmonary complications 

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between the intervention group and the control group. This difference is assessed using 
univariate analyses and ANCOVA (Analysis of Covariance) models. Demographic and 
baseline characteristics between groups are assessed using the non-parametric Wilcoxon 
Rank-Sum test for continuous data, and Pearson Chi-squared test or Fisher’s Exact test 
(when expected frequencies are small) for categorical data. The secondary outcomes will be 
analyses using the same statistical methods, based upon the data distributions. Data analyses 
will be performed by a statistician with the Center for Data Solutions.  
 
 
Possible Discomfort and Risks 
• Participants may be in some discomfort due to their planned head and neck surgery. 
Patients in this study will be receiving our current standard of care (COT) or HFOT 
therapy, which is also an established standard of care modality.  Thus, risks to 
patients are low, and have not been observed in similar studies. 
 
There is the minimal risk of a participant’s privacy being compromised.  Several 
measures to ensure the privacy protection of those enrolled in the study will be in 
place as described in the Patient Privacy and Protection section on page 11. 
 
 
 
Possible Benefits 
• There may be a benefit to those randomized to HFOT oxygen versus COT or there may 
not be any difference between the two in reducing postoperative pulmonary 
complications.   The results of this study will help guide best practices in the 
postoperative care of head and neck cancer surgical patients. 
 
Conflict of Interest 

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• This study is funded by Fisher and Paykel, Inc., manufacturers of the Airvo 2 high flow 
device 
• However, the sponsor company cannot interfere with the study, data collection, or 
statistical analysis 
 
Data Safety Monitoring Board 
• No experimental interventions are taking place, as HFOT tracheostomy delivery and 
conventional oxygen therapy are both well established and widely used modalities.   
• The PI will monitor for any adverse events.  If any adverse events are identified, they 
will be reported to the IRB in the required time frames. 
Anticipated study duration: 14-24 months 
 
 
 
 
 
 
 
 
 
 
 
References 
 
1. McMahon JD, MacIver C, Smith M, Stathopoulos P, Wales C, McNulty R, Handley TP, Devine 
JC. Postoperative complications after major head and neck surgery with free flap repair--
prevalence, patterns, and determinants: a prospective cohort study. Br J Oral Maxillofac Surg. 
2013 Dec;51(8):689-95. doi: 10.1016/j.bjoms.2013.04.015. Epub 2013 May 31. PMID: 
23727043. 

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2. Twose P, Thomas C, Morgan M, Broad MA. Comparison of high-flow oxygen therapy with 
standard oxygen therapy for prevention of postoperative pulmonary complications after 
major head and neck surgery involving insertion of a tracheostomy: a feasibility study. Br J 
Oral Maxillofac Surg. 2019 Dec;57(10):1014-1018. doi: 10.1016/j.bjoms.2019.08.021. Epub 
2019 Sep 9. PMID: 31515152. 
3. Loeffelbein DJ, Julinek A, Wolff KD, Kochs E, Haller B, Haseneder R. Perioperative risk factors 
for postoperative pulmonary complications after major oral and maxillofacial surgery with 
microvascular reconstruction: A retrospective analysis of 648 cases. J Craniomaxillofac Surg. 
2016 Aug;44(8):952-7. doi: 10.1016/j.jcms.2016.05.007. Epub 2016 May 14. PMID: 
27259678. 
4. Petrar S, Bartlett C, Hart RD, MacDougall P. Pulmonary complications after major head and 
neck surgery: A retrospective cohort study. Laryngoscope. 2012 May;122(5):1057-61. doi: 
10.1002/lary.23228. Epub 2012 Mar 23. PMID: 22447296. 
5. Ong S, Morton RP, Kolbe J, Whitlock RML, McIvor NP. Pulmonary Complications Following 
Major Head and Neck Surgery With Tracheostomy: A Prospective, Randomized, Controlled 
Trial of Prophylactic Antibiotics. Arch Otolaryngol Head Neck Surg. 2004;130(9):1084–1087. 
doi:10.1001/archotol.130.9.1084 
6. Paleri V, Wight RG, Silver CE, Haigentz M Jr, Takes RP, Bradley PJ, Rinaldo A, Sanabria A, Bień 
S, Ferlito A. Comorbidity in head and neck cancer: a critical appraisal and recommendations 
for practice. Oral Oncol. 2010 Oct;46(10):712-9. doi: 10.1016/j.oraloncology.2010.07.008. 
Epub 2010 Sep 17. PMID: 20850371. 
7. Heffner JE, Hess D. Tracheostomy management in the chronically ventilated patient. Clin 
Chest Med. 2001 Mar;22(1):55-69. doi: 10.1016/s0272-5231(05)70025-3. PMID: 
11315459. 
8. Doyle, A. et al.  A change in humidification system can eliminate endotracheal tube 
occlusions. Journal of Critical Care 26, 637. e1-637.e4 (2011) 
9. Burton, J.D.K. Effects of dry anesthetic gases on the respiratory mucous membrane.  Lancet 
279, 235-238 (1962). 
10. Branson, R.D. Secretion management in the mechanically ventilated patient. Respiratory 
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11. Nishimura M. High-Flow Nasal Cannula Oxygen Therapy in Adults: Physiological Benefits, 
Indication, Clinical Benefits, and Adverse Effects. Respir Care. 2016 Apr;61(4):529-41. doi: 
10.4187/respcare.04577. PMID: 27016353. 
12. Kim HJ, Asai T. High-flow nasal oxygenation for anesthetic management. Korean J 
Anesthesiol. 2019 Dec;72(6):527-547. doi: 10.4097/kja.19174. Epub 2019 Jun 5. PMID: 
31163107; PMCID: PMC6900423. 
13. Chaudhuri D, Granton D, Wang DX, Burns KEA, Helviz Y, Einav S, Trivedi V, Mauri T, Ricard 
JD, Mancebo J, Frat JP, Jog S, Hernandez G, Maggiore SM, Mbuagbaw L, Hodgson CL, Jaber S, 
Goligher EC, Brochard L, Rochwerg B. High-Flow Nasal Cannula in the Immediate 
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14. Bhattacharyya N, Fried MP. Benchmarks for Mortality, Morbidity, and Length of Stay for 
Head and Neck Surgical Procedures. Arch Otolaryngol Head Neck Surg.2001;127(2):127–
132. doi:10.1001/archotol.127.2.127 
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Am Fam Physician. 2016 Nov 1;94(9):698-706. Erratum in: Am Fam Physician. 2017 Apr 
1;95(7):414. PMID: 27929242. 
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diagnosis, management, and prevention of chronic obstructive pulmonary disease; 
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March 14, 2007). 
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Figure 1.  Oral and Maxillofacial Surgery Free Flap Management Protocol by Postoperative Day 
 
 
Day 0 
Day 1 
Day 2 
Day 3 
Day 4 
Day 5 
Day 6 
Day 7 
Discharge Goals 
Trachea/Airway 
  
Trach suction by respiratory every 6 hours 
 
Albuterol/ipratropium nebulized q 6 hours 
scheduled until decannulated or discharged 
Trach 
changed to 6 
cuffless, 
fenestrated 
tube 
CAN CAP IF 
READY 
Decannulate 
when 
capped >24 
hours 
  
Trach tube out or all at-
home supplies and care 
instruction provided 
 
Flap Donor Site 
Dressing kept until 
discharge 
Dressing to be changed 
at first follow-up 
 
Skin Graft Donor Site 
Dressing kept until 
discharge 
Skin graft dressing 
change at first follow-up 
 
Flap Checks 
Every two hours 
  
Every 4 
hours after 
48 hours 
Flap checks 
discontinued upon 
discharge 
 
Drains 
JP drains to bulb suction 
with output, recorded 
  
Discontinue 
drains when 
<30 ml / 24 
hours 
 
Laboratory 
  
Complete blood count, basic metabolic 
panel, magnesium, phosphorus, others as 
indicated each morning 
Discontinue 
labs when 
IVF 
discontinued 
 
 
IV Fluids, Antibiotics 
One dose of abx prior to 
incision 
Continue 
antibiotics 3 
doses post-
op 
Titrate IV 
fluids to 
heplock to 
accommodate 
TF rate 
D/C IVF 
when TF at 
goal 
Antibiotics until POD 7 
 

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Pain Management 
IV pain meds 
Oral pain 
medication 
with IV for 
BTP 
  
Narcotic 
pain meds 
weaned as 
tolerated 
Pain control on oral 
medication alone 
 
Delirium Tremens 
Prophylaxis 
CIWA protocol as 
appropriate 
 
Activity 
Bedrest 
Bedrest 
Bedrest or 
sitting on 
edge of bed 
To chair 
Ambulate 
Ambulate 
Ambulate 
Ambulate 
Baseline mobility or 
independent at home 
 
Nutrition 
NPO. Meds only pre NGT 
After 24 
hours, start 
tube feeds 
P.O. trials or 
start bolus 
tube feed 
D/C NGT 
or arrange 
for TF 
upon D/C 
  
Tolerate at least full 
liquids or home with 
enteral feed teaching 
machine 
 
Catheter 
Maintain Foley catheter 
D/C Foley 
 
Gastrointestinal 
PPI to start post-operatively 
Stool softeners 
Discharge with normal 
bowel function, no GI 
bleed 
 
Thromboprophylaxis 
Compression stockings, 
SCDs during and after 
surgery 
Prophylactic 
lovenox, ASA 
325mg/d to 
start at 24 
hours 
 
Discharge with no deep 
vein thrombosis, or 
pulmonary embolism 
 
Miscellaneous 
  
Consult PT, 
nutrition, 
respiratory, 
case 
manager, 
speech 
therapy 
  
  
  
  
  
  
Smooth and timely 
discharge with high 
patient satisfaction