Clinical Research Directory

EXtubation Related Complications - the EXTUBE Study (EXTUBE)

EXTUBE is an international, multicentre, prospective cohort study evaluating the incidence, risk factors, and outcomes of extubation-related complications and describing clinical practices related to extubation after general anesthesia or after critical illness in the operating room (OR), out of OR anesthesia location or intensive care unit (ICU).

Does Positive Pressure Extubation Reduce Postoperative Desaturation?

Single-center, prospective, controlled, parallel, randomized, single-blind study comparing the conventional extubation technique to two positive pressure extubation techniques on postoperative desaturations

Endotracheal Suctionning During Positive Pressure Extubation in ICU

The aim of this clinical trial is to evaluate endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients (over 18 years old) in the intensive care unit (ICU). The main question it aims to answer is whether the intervention improves the respiratory oxygenation index (ROX) three hours after extubation compared to no endotracheal suction during positive pressure extubation. Participants will only need to be extubated by the nursing team in the ICU. Follow-up will consist of evaluating respiratory rate, pulse oximetry and inspired oxygen fraction for three hours following extubation.

Total Intravenous Anesthesia (TIVA)/Sevoflurane Initiated Intravenous Anesthesia (SIIVA) in Pediatric Patients

Because Propofol is the primary "anesthetic agent," and inhalational agents remain in trace quantities at the end of the procedure Sevoflurane initiated intravenous anesthesia (SIIVA) or not present at all Total intravenous anesthesia (TIVA) it is likely that different criteria may be predictive of extubation success in these patients compared to inhalational anesthesia.

Spontaneous Breathing Trials Using Pressure Support or T-Piece in Overweight and Obese Patients

This study aims to find out which method of spontaneous breathing trial (SBT) better helps overweight and obese ICU patients prepare for extubation, which is the removal of the breathing tube. The two methods being compared are pressure support ventilation (PSV) and the T-piece. Participants are adults with a body mass index (BMI) of 25 or higher who have been on a breathing machine (invasive mechanical ventilation) for more than 24 hours. Before removing the breathing tube, participants will be randomly assigned to receive either a PSV or a T-piece trial for 1 hour. After that, doctors will decide if they are ready for extubation. The main question this study wants to answer is: Which method leads to a higher rate of successful extubation-defined as not needing to be reintubated within 72 hours?

Post-extubation Use RAM Cannula Versus Short Binasal Prong Interfaces in Preterm Infants

Nowadays, the use of non-invasive ventilation for preterm infants in the NICU has increased to avoid complications associated with prolonged endotracheal intubation. Adequate pressure delivery through non-invasive ventilation is essential, as it enhances the growth and development of premature lungs. Various interfaces have been used to ensure proper sealing. The RAM cannula, used as an interface for non-invasive respiratory support in preterm neonates, is associated with reduced nasal trauma compared to short binasal prongs (SBPs), due to its softer material, making it a safer option. However, the RAM cannula has been shown to deliver lower pharyngeal pressure and, therefore, may not maintain airway pressure as consistently as nasal prongs. Currently, limited data is available regarding the efficacy of nasal prongs compared to the RAM cannula as a post-extubation interface for non-invasive ventilation support in preterm infants. Additionally, we have observed that the use of the RAM cannula for non-invasive ventilation in preterm infants is associated with a longer duration of oxygen therapy compared to SBPs. The investigators hypothesize that the RAM cannula provides a lower level of positive end-expiratory pressure compared to SBPs during non-invasive ventilation. The investigators aim to assess the efficacy and safety of the RAM cannula versus SBPs as nasal interfaces for post-extubation non-invasive respiratory support in preterm infants.

High-Flow Nasal Cannula vs. NIV After Extubation in Children Undergoing Heart Surgery

High-Flow Nasal Cannula vs. NIV After Extubation in Children Undergoing Heart Surgery

Modified Deep Extubation vs. Standard Awake Extubation

The proposed study is to compare a modified DE technique, which is regularly used for low-risk patients by staff anesthesiologists at our institution, to a standard awake extubation. This modified deep extubation (mDE) occurs while the patient is still anaesthetized but at a lower dose of anaesthetic gas than previously described, and balanced with long acting opioids to attenuate the airway reaction. As previously stated, the literature shows that the risks of DE are equivalent to those of regular AE practice. Our hypothesis is that mDE will shorten the time from the end of the surgery (completion of last stitch) to the moment the patient is ready to leave the OR by at least 5 minutes when compared to standard AE practice.

Effect of Percutaneous Electrical Acupoint Stimulation on the Improvement of Incidence of Adverse Respiratory Events

The goal of this study is to investigate the effect of combined acupoint electrical stimulation at Taiyuan (LU9) and Hegu (LI4) on improving the incidence of respiratory adverse events after extubation in patients during the recovery period from general anesthesia. The main content of this study involves selecting patients who have undergone general anesthesia and are admitted to the Post Anesthesia Care Unit (PACU), with an expected 236 participants. The researchers will randomly assign participants to either the TEAS group or the control group using a random number table. In the TEAS group, electrodes will be applied to the upper limbs at the Taiyuan and Hegu acupoints, without intravenous infusion, and connected to a stimulation device. The stimulation will use a frequency of 2/100 Hz with sparse-dense waves, and the intensity will be adjusted to the maximum current that the patient can tolerate, starting at the time of extubation and continuing for 30 minutes. The control group will receive routine care. Throughout the process, no invasive procedures will be performed. In the PACU, the participants will: Be positioned in a 30° head-up tilt position, with continuous ECG monitoring. The SpO2 alarm on the monitor will be set to 95%. The same anesthesiologist will perform extubation according to the extubation criteria. After extubation, participants will receive routine oxygen therapy via a nasal cannula at 3L/min with a CO2 end-expiratory monitoring module attached to the other end of the cannula. Simultaneously, the TEAS group will undergo transcutaneous electrical stimulation for 30 minutes, or the control group will receive routine care. Participants will be observed in the PACU for at least 30 minutes. If no adverse events occur and the Steward score is ≥4, the patient will be deemed ready for discharge and escorted back to the ward. If there is any significant change in the patient's condition, they will be transferred to the ICU . If any respiratory-related adverse events occur, measures such as awakening the patient, supporting the jaw, increasing oxygen flow, or administering mask oxygen will be taken to ensure patient safety, and these events will be recorded in the "PACU Postoperative General Anesthesia Patient Condition Observation and Nursing Record."

Postoperative Extubation in Hypoxemic Patients

The objective of this clinical trial is to assess whether early extubation of patients with hypoxemia during the spontaneous breathing trial (SBT) shortens the duration of ventilatory support. The trial will also evaluate the safety of this approach. The key research questions include: Does early extubation of hypoxemic patients reduce the total duration of ventilatory support (both invasive and non-invasive) by 36 hours? Does early extubation of hypoxemic patients increase the number of ventilator-free days by day 28? Can the safety of early extubation in hypoxemic patients be ensured by confirming no significant differences in rates of reintubation, tracheostomy, or mortality? The trial will compare ventilatory outcomes between two groups: hypoxemic patients who undergo early extubation (hypoxemic extubation group) and those who remain on invasive ventilation until hypoxemia resolves (conventional extubation group).

Effectiveness on Smooth Extubation According to the Administration Time of Sugammadex

After surgery is completed under general anesthesia, extubation is performed after recovery from anesthesia, and during this process, bucking, coughing, and rapid and excessive hemodynamic fluctuations occur very often. These phenomena can lead to high intrathoracic pressure, venous congestion, hematoma formation, or increased bleeding after major neck surgery. (1) They can also increase the risk of aerosol generation, which can transmit infection to health care workers. (2) For this, smooth extubation is required. Methods of administering drugs such as lidocaine, opioids, or dexmedetomidine have been proposed for smooth extubation. (3-5) As a disadvantage, the use of these drugs may be associated with deep sedation and reduced airway reflexes . Recently, Babu et al. (6) reported that bucking and coughing during extubation could be reduced by changing the timing of administering a muscle relaxant antagonist rather than using these sedative drugs, and thus complications related to extubation could be reduced. In general, in the awakening process, it was common to administer the muscle relaxant at the point of recovery of spontaneous breathing. However, Babu et al. demonstrated the possibility of safe and smooth extubation by changing the timing of administering neostigmine without the use of sedatives or narcotic analgesics, but there are few studies on sugammadex. Therefore, when recovering from general anesthesia, sugammadex was administered before and immediately after extubation to evaluate and compare smooth extubation (ie, comparison of the frequency of bucking and coughing).

The External Diaphragm Pacemaker Assisted Extubation in Premature Infants With Invasive Mechanical Ventilation

With the development of perinatal medicine, more and more newborns with respiratory failure can be treated due to the use of respiratory support technology. However, long-term invasive mechanical ventilation treatment can lead to a series of complications such as ventilator-associated pneumonia, atelectasis and air leakage syndrome, and increase the risk of bronchopulmonary dysplasia and neurodevelopmental lag of premature infants. It also leads to longer hospital stays and higher hospital costs. To shorten the invasive mechanical ventilation time and improve the success rate of withdrawal through various ways is the development direction of neonatal mechanical ventilation therapy. Respiratory muscle atrophy is common and rapid in children receiving invasive mechanical ventilation, and is an important cause of ventilator dependence and withdrawal failure. The diaphragm of newborns is the main respiratory muscle, of which the diaphragm type 1 endurance fiber accounts for only about 30%, far lower than the proportion of about 55% in adults, so the diaphragm of newborns is more prone to fatigue. Previous animal experiments and clinical studies in children and adults have confirmed that diaphragmatic pacing therapy applied to patients with long-term invasive mechanical ventilation can prevent diaphragmatic atrophy, reverse diaphragmatic injury, significantly improve diaphragmatic thickness, improve diaphragmatic anti-fatigue ability, thereby increasing lung ventilation, relieving dyspnea, and achieving the effect of assisted extubation. The neonatology Department of the Children's Hospital Affiliated to Chongqing Medical University started neonatal external diaphragm pacemaker treatment in 2022, and has completed 1383 cases so far, initially showing the effectiveness and safety of external diaphragm pacemaker treatment in neonatal population. But so far, there is no systematic evaluation of clinical intervention effect of external diaphragm pacemaker treatment on neonatal respiratory failure patients at home and abroad. Based on this, the project team intends to conduct a prospective randomized controlled study to systematically evaluate the safety of external diaphragm pacemaker in preterm infants requiring invasive mechanical ventilation for ≥7 days at 28 to 35 weeks of gestation, and to evaluate the efficacy of external diaphragm pacemaker in adjuvant extubation.