- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04123522
Using the High Resolution Impedance Manometry to Evaluate Swallowing Function After Cervical Spine Surgery
Using the High Resolution Impedance Manometry to Evaluate Swallowing Function After Cervical Spine Surgery: Anterior vs Posterior Approach
Dysphagia is a well-known complication following cervical spine surgery, including anterior or posterior approach. However, which muscle at oropharyngeal region weakness and the recovery course of these patients are still unknown.
The high resolution impedance manometry (HRIM) could be used to measure the postoperative recovery esophageal function.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Dysphagia is a well-known complication following cervical spine surgery, including anterior or posterior approach. However, which muscle at oropharyngeal region weakness and the recovery course of these patients are still unknown.
The high resolution impedance manometry (HRIM) could be used to measure the postoperative recovery esophageal function.
In this study, using the high resolution impedance manometry to determine (1) whether the occurrence of dysphagia in the postoperative 1 or 7 days and 1 month in the patients receiving anterior vs posterior approach of cervical spine surgery (2) which muscle in the pharyngeal region would be destroyed Consecutive patients who will fulfill the criteria of cervical spine surgery patients under general anesthesia and aged >= 20 will be enrolled. The patients would receive the dysphagia questionnaire. All subjects would receive the swallowing function by HRIM before the surgeries. The cough test was also measured. After the surgery, the patient would be followed the swallowing function in the postoperative one day, and 1 week by HRIM and questionnaire.
This study would expect (1) that the posterior cervical spine surgery would result in dysphagia greater than baseline, but less than that of anterior cervical procedures; (2) decreasing upper esophageal sphincter (UES) pressure may be the reason of postoperative dysphagia in the anterior cervical spine surgery, resulted from the intraoperative traction; (3) decreasing hypopharyngeal muscle pressure may be the reason of postoperative dysphagia in the posterior spine surgery, resulted from the prone and flexion positioning.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:1. Patients who fulfill the criteria of cervical spine surgery under general anesthesia 2. Aged from 20-80 years old -
Exclusion Criteria:
- 1. Major systemic disease, such as congestive heart failure, liver cirrhosis, end stage renal disease and malignancy.
2. Patients who have the risk of difficult ventilation or intubation. 3. pregnant women 4. coagulopathy
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
anterior cervical spine surgery
The patients will be enrolled for elective anterior cervical spine surgery.
|
anterior approach
Andra namn:
|
|
posterior cervical spine surgery
The patients will be enrolled for elective postieor cervical spine surgery
|
posteiror appraoch
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
mean pharyngeal peak pressure
Tidsram: preoperative, postoperative day 1 and 7
|
the pharyngeal presssure change during swallowing
|
preoperative, postoperative day 1 and 7
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 201907079RINA
Plan för individuella deltagardata (IPD)
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