Treatment Trials

22 Clinical Trials for Various Conditions

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COMPLETED
Assessment of Breathing Using an Under-bed Weighing Scale
Description

The aim of this study is to assess the capability of a modified under bed weighing scale (contact-free unconstrained respiratory monitor, BSS) to predict postoperative pulmonary complications in high-risk surgical patients. The study is designed to test the hypothesis that abnormal breathing measured by a modified under bed weighing scale predicts postoperative pulmonary complications within 7 days after surgery.

TERMINATED
Effect of Preoperative Incentive Spirometer on Postoperative Pulmonary Complications Following Lung Resection
Description

The objective of this study is to demonstrate that inspiratory muscle training with daily use of an incentive spirometer for at least 14 days prior to lung surgery will reduce the risk of post-operative pulmonary complications.

WITHDRAWN
Preoperative Self-managed Respiratory Therapy for Reduction of Postoperative Pulmonary Complications
Description

Postoperative pulmonary complications (PPCs) are a source of much morbidity and mortality. Rates of PPCs exceed 30% in patients with multiple risk factors. Several studies have demonstrated reduced PPCs in patients who underwent preoperative inspiratory muscle training. These studies largely focused on cardiothoracic surgery and required the use of respiratory therapists. The investigators hypothesize that preoperative, self-administered respiratory therapy would reduce PPCs in patients with risk factors for PPCs undergoing any non-cardiothoracic surgery. This study is a randomized, controlled trial comparing preoperative use of an incentive spirometry device with usual care in patients undergoing non-emergent, non-cardiothoracic surgical procedures under general anesthesia.

COMPLETED
PROVHILO:Protective Ventilation During General Anesthesia for Open Abdominal Surgery
Description

The purpose of this international, multicentre, double-blinded randomized controlled trial is to determine if the "open lung approach" providing recruitment maneuvers and PEEP(Positive End Expiratory Pressure) during general anesthesia reduces atelectasis formation and improves respiratory function in the immediate post-operative period after major abdominal surgery. Participating centres throughout the world will include a total of 900 adult patients undergoing general anesthesia for open abdominal surgery with high or intermediate risk for post-operative pulmonary complications. Patients are randomized and intra-operatively ventilated with either a lung protective strategy (PEEP at 12 cmH2O with recruitment maneuvers) or a conventional strategy (PEEP at maximum 2 cmH2O without recruitment maneuvers). Patients will be assessed on the first 5 post-operative days, on day of discharge and on day 90 post-operative. Primary endpoint is any post-operative pulmonary complication (see below). Secondary endpoints are post-operative extra-pulmonary complications, intra-operative mechanical ventilation related complications, unscheduled ICU (Intensive Care Unit) (re-) admission, and length of hospital stay.

COMPLETED
Recovery of Ventilation After Anesthesia for Laparoscopic Nephrectomy
Description

The purpose of this randomized, controlled feasibility investigation is to characterize pharmacologically induced ventilatory depression after anesthesia and examine how is affected by the amount of supplemental oxygen patients are receiving in the immediate postoperative period.

COMPLETED
Validation of the REPS Prediction Tool
Description

Neuromuscular blocking agents' (NMBA) use during surgery is associated with postoperative respiratory complications and increased risk of readmission to the hospital following ambulatory surgery. Residual neuromuscular block (rNMB) after surgery is difficult to identify. We have recently developed the REsidual neuromuscular block Prediction Score (REPS), that predicts the risk for postoperative rNMB. Our primary objective is now to assess the predictive ability of the REPS for respiratory complications within seven days following general anaesthesia. The secondary objective is to compare the predictive values of REPS and train-of-four (TOF)-ratio below 0.90 for respiratory complications.

COMPLETED
Intraoperative Protective Ventilation and Postoperative Pulmonary Complications
Description

The purpose of this pilot study is to identify the optimal way to ventilate patients during abdominal surgery in order to reduce the amount of post-operative pulmonary complications in patients at moderate and high-risk for them.

COMPLETED
Risk Factors for Post-Operative Respiratory Complications in Patients at Risk for OSA
Description

This study investigates the incidence of postoperative respiratory complications (PRCs) including: oxygen desaturation events, tracheal re-intubations within 48 hours of surgery, and failure to wean from ventilator within 48 hours of surgery - in patients with and without risk factors for OSA undergoing elective, non-cardiac surgery (NCS).

COMPLETED
Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study)
Description

Intraoperative intravenous fluid management practice varies greatly between anesthesiologists. Postoperative fluid based weight gain is associated with major morbidity. Postoperative respiratory complications are associated with increased morbidity, mortality and hospital costs. The literature shows conflicting data regarding intraoperative fluid resuscitation volume. No large-scale studies have focused on intraoperative fluid management and postoperative respiratory dysfunction. Hypotheses: Primary - Liberal intraoperative fluid resuscitation is associated with an increased risk of 30 day mortality Secondary - Liberal intraoperative fluid resuscitation is associated with increased likelihood of postoperative respiratory failure, pulmonary edema, reintubation, atelectasis, acute kidney injury and peri-extubation oxygen desaturation.

COMPLETED
Focused Incentive Spirometry Monitoring to Reduce Postoperative Oxygen Therapy and Respiratory Complications After Bariatric Surgery
Description

Postoperative (PO) hypoventilation, atelectasis and hypoxemia after bariatric surgery are common and multifactorial, contributing to prolonged oxygen (O2) therapy after surgery and even at hospital discharge. Incentive spirometry (IS) is recommended postoperatively but its success in preventing postoperative atelectasis and hypoxemia (POH) heavily depends on patient compliance with IS effort and frequency. The investigators hypothesize that a focused education preoperatively on IS for POH and intensive monitoring of patient compliance with IS therapy in the early postoperative period shortens postoperative oxygen therapy, decreases POH episodes, and improves respiratory outcomes after bariatric surgery, compared to patients receiving standard of care.

RECRUITING
Dexmedetomidine Infusion and Postoperative Lung Aeration After Thoracic Surgery
Description

This will be a randomized, placebo-controlled, double-blinded, pilot trial with two parallel groups (1:1 ratio) receiving either dexmedetomidine (initial bolus of 1 mcg/kg over 30 min after induction, followed by an infusion rate of 0.3 mcg/kg/hr that will be stopped 30-45 minutes before the end of the surgery or upon reaching maximum dose of 2mcg/kg, whichever comes first) or placebo (normal saline as a bolus followed by maintenance infusion at the same rate of the intervention group). Dexmedetomidine is frequently administered in thoracic surgery. Using local data from the Brigham and Women's Hospital, dexmedetomidine was used in a third of the thoracic procedures performed over the past three years. However, there is no consensus as to the optimal protocol of administration, therefore clinical practice is highly heterogeneous (bolus versus continuous infusion) and mostly depends on the preferences of anesthesia providers. In our institution, the dose of dexmedetomidine is typically 0.5 mcg/kg but varies based on attending preferences and experience. Given the heterogenous practices in dexmedetomidine administration, one of the objectives is to assess the feasibility of adhering to a dexmedetomidine protocol using an initial loading dose of 1 mcg/kg over 30 minutes after induction followed by a continuous infusion of 0.3 mcg/kg/hr. The infusion will stop 30-45 minutes prior to the end of surgery or once a maximum dose of 2mcg/kg has been achieved, whichever comes first. The control group will receive normal saline (similar bolus followed by maintenance infusion at the same rate of the intervention group).

RECRUITING
Postoperative Respiratory and Activity Monitoring
Description

This study plans to learn more about specific breathing and activity recommendations for patients after surgery. Participants will be monitored after abdominal surgery to identify what activities help them breathe better and reduce complications after surgery.

COMPLETED
A Pilot Trial of Continuous Portable Postoperative Hemodynamic And Saturation Monitoring On Hospital Wards
Description

The study team will collect data for this study from participants who are having surgery and recovering postoperatively on 2 pre-designated hospital units. The study team will use vital signs data from a portable device that participants wear on their wrists as well as conventional vital signs data that is collected when a health care provider comes into their room and collect this information. A substudy is also being performed with the distribution of surveys to the nursing staff on the floors who are utilizing the ViSi hemodynamic monitors within our institution.

COMPLETED
Evaluation of Respiratory Acoustic Monitor in Children After Surgery
Description

The study will evaluate the performance of measuring respiration rate with the Respiratory Acoustic Monitoring (RAM).

RECRUITING
Hyperinflation Respiratory Therapies in Cardiac Surgery Patients
Description

The purpose of this prospective randomized clinical trial is to evaluate three different types of hyperinflation respiratory therapies, Intermittent Positive Pressure Breathing (IPPB), Intermittent positive end expiratory pressure (EzPAP), Metaneb. Investigators will examine which hyperinflation therapy provides better lung expansion and may improve lung recovery after surgery.

COMPLETED
Hemodynamic and Respiratory Variations During Laparoscopic Surgery With and Without Deep Neuromuscular Blockade.
Description

The goal of this study is to investigate the effect of depth of neuromuscular block (NMB) on global and regional (dependent versus nondependent) respiratory mechanics during laparoscopic surgery. Furthermore, we will investigate if the level of NMB influences intraoperative hemodynamic and cerebral oxygenation.

COMPLETED
Factors Predictive of Adverse Postoperative Outcomes in Children Undergoing Tonsillectomy
Description

The purposes of the study are to identify 1) the patient (demographic and clinical) and health care system factors predictive of immediate and late postoperative adverse outcomes in children undergoing tonsillectomy. 2) Evaluate the preoperative use of the sleep questionnaire to identify children at risk for immediate and late postoperative adverse outcomes in children undergoing tonsillectomy.

COMPLETED
The Effect of Caffeine on Postextubation Adverse Respiratory Events in Children With Obstructive Sleep Apnea (OSA).
Description

This is a research study using caffeine in children who have an obstructive sleep apnea (OSA). OSA means children who stop breathing during their sleep due to obstruction in their airway. The purpose of this study is to determine whether caffeine when given in the vein, will wake children up faster and decrease post-anesthesia airway obstruction, as well as the safety and if the drug agrees with the child compared to a placebo (an inactive or dummy agent).

TERMINATED
Avoiding Neuromuscular Blockers to Reduce Complications
Description

The goal of this study to evaluate whether eliminating the use of non-depolarizing neuromuscular blocking agents (NMBA) for maintenance of general anesthesia reduces postoperative pulmonary complications in higher risk patients.

COMPLETED
REMINDers for Incentive Spirometry in PACU (REMIND-IS in PACU)
Description

The purpose of this study is to determine if the frequency of use of incentive spirometry during the stay in the Post-Anesthesia Care Unit (PACU) increases with visual and auditory electronic reminders, as compared to not having those reminders.

COMPLETED
Application of Capnography Monitoring on the General Care Nursing Unit
Description

The aim of this study is to increase the detection of undiagnosed obstructive sleep apnea (OSA) and secondly to increase the sensitivity for detection of respiratory depression (\< 6 breaths per minute) in post operative patients on the general care nursing unit.

COMPLETED
Local Assessment of Ventilatory Management During General Anesthesia for Surgery
Description

Objectives 1. To characterize mechanical ventilation practices during general anesthesia for surgery 2. To assess the dependence of intra-operative and post-operative pulmonary complications on intra-operative Mechanical Ventilation (MV) settings