A Double Blinded, Randomized Controlled Trial of the Use of Osteopathic Medical Manipulation to Decrease the Incidence and Severity of Post-Operative Sore Throat

Subjects are selected in the pre-operative area, based on inclusion criteria the night prior from the operating room list, and given 5 minutes of OMT within 1 hour of intubation and then given a less than 5 minute pre-extubation treatment in the operating room no earlier than 1 hour and no later than 15 minutes prior to expected extubation. The patient will be given a survey to be answered at 1 hour, 6 hours, and 24 hours post operatively. Surveys will be filled out in the hospital by the investigating team electronically or by the subject online after they have departed the hospital (See data collection section for more detail on this procedure). In this manner, the subjects' bias and placebo effect will have limited impact on the study outcomes. There will be randomization tables for men and for women to ensure equal representation of women in both arms of the trial since they bear an independent risk factor by their gender. The intubating anesthesiologist will not know which arm the subject is placed in and will be not be present when the pre-operative treatment is taking place to prevent recognition of sham vs. protocol treatment and possible bias. To accomplish this, treatment will be completed behind a closed curtain. Furthermore, it is unlikely that providers will be able to tell the difference between the sham and protocol treatments if they should see treatment being accomplished. In order to ensure patients meet the 1 hour treatment to intubation criteria patients will be selected from the list of first starts or if they are not on the first start list, treatment will be performed when that patients OR room is in turnover as turnover times average 30+ minutes at this hospital. By performing treatments in this manor there is less risk of OR delays which may prolong treatment to intubation time.

The conduct of the anesthetic is entirely at the discretion of the anesthesia provider but in order to avoid confounding variables there are several requests that will be made concerning the conduct of the anesthetic. If these requests are ignored for the benefit of the patient the subject will be removed from the study as described in this section.

Medications for the induction of anesthesia will be at the provider's discretion, but should include a paralytic and avoid ketamine whenever possible. Use of airway adjuncts such as lidocaine laryngo-tracheal atomizers, lidocaine lollypops, ETT lubrication, etc should be avoided and will result in subject exclusion from this study if used. The exclusion of airway adjuncts is for obvious reasons and the paralytic requirement is to control for subject gag reflex differences that may cause excess trauma to the throat in those with sensitive gag reflexes. Ketamine should be avoided due to the risk of excessive secretions that may result in subject coughing or increased instrumentation with a suction device, and to control for the high analgesia that ketamine might impart to subjects that could skew the data analysis. Use of ketamine during the case will result in removal of the patient from the study, but the lack of paralytic use will not exclude the subject from this study. ETT selection, stylet use, and direct laryngoscopy (DL) blade type/size will be at the provider's discretion. A maximum of 2 intubation attempts will be allowed for subject inclusion into this study to prevent confounding variables of subject anatomy and difficult airways from skewing the data. Only providers with 100 or more intubations should perform intubations on study participants in order to control for poor technique and deviation from this will result in subject removal from the study. ETT cuff pressure should be set at <25cm H2O by aneroid manometer per standard practices. Standard American Society of Anesthesiologists recommended monitors will be employed and maintenance medications will be at provider's discretion with the exception of nitrous oxide which should be avoided due to the potential that it could diffuse into the ETT cuffs causing increased cuff inflation pressure, but will not be a criteria for exclusion from the study. Orogastric and nasogastric tubes should also be avoided as they are a known risk factor for POST but due to the prevalence of their use in this study's potential population their use will not result in study exclusion. Reversal and extubation will be at the provider's discretion with standard extubation criteria and gentle suctioning of oropharyngeal secretions as needed for subject safety. Oropharyngeal suctioning should be avoided if possible due to its link to POST, but its exclusion would pose undue risk of aspiration. Effort should be made to conduct oropharyngeal suctioning as gently as possible. Intraoperative and postoperative analgesics and steroids will be at provider's discretion. All postoperative and intraoperative analgesics will be recorded with time given by the investigative team from the medical record.

No earlier than 1 hour and no later than 15 minutes prior to expected extubation, an additional short OMT session will be conducted in the OR with the subject still anesthetized. The intraoperative session is designed to be less than 5 minutes and will involve minimal to no movement of the subjects head or body so as to not to disturb the surgical team and to prevent the dislodgement of the ETT. Intraoperative treatment is directed at myofascial structures to increase lymphatic and vascular flow to wash away inflammatory products and therefore does not require the subject to be moved or to participate in the treatment. Intra-operative treatment is preferred over post-operative treatment so that inflammatory products can be removed prior to the initial post-operative assessment. Additionally, post-operative treatment sessions could be significantly compromised by patient post-anesthetic agitation/delirium and would require an additional sham treatment to prevent patient un-blinding. There will be no intra-operative treatment for the sham arm of the study to save time and decrease the chance for operative interference. All patients will be told in the recruitment phase that they may receive a second treatment inter-operatively as part of the consent for participation process. Intubation surveys will be conducted prior to the intra-operative treatment session to prevent anesthesia provider bias when they recognize the patient is or is not receiving the second OMT session. At this point there is no further risk of bias to the study by un-blinding the provider.

OMT protocol: