Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482885
Status:
COMPLETED
Last Update Posted:
2011-06-27
First Post:
2007-06-01
Brief Title:
Coordination Versus Pressure in Oesophageal Peristalsis
Sponsor:
Guys and St Thomas NHS Foundation Trust
Organization:
Guys and St Thomas NHS Foundation Trust
Study Overview
Official Title:
The Effect of Position on Oesophageal Peristalsis and LOS Pressures a High Resolution Manometry Study
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
High Resolution Manometry HRM is a new advance in oesophageal measurement that permits the acquisition of pressure data through the entire length of the oesophagus over time via closely spaced sensors that continuously record the motor activity of the oesophagus This allows not only contractile pressure to be measured but also the coordination proximal-distal of contractions and the development of effective intra-bolus pressure the force that drives bolus movement
The study hypothesis is that 1 there will be a progressive increase in peristaltic pressure and decrease in velocity as the subjects move from the upright through the supine to the upside down position and 2 the increase in pressure will be most evident in the mid-oesophagus at the transition zone between the striated and the smooth muscle contractions
The study hypothesis is that 1 there will be a progressive increase in peristaltic pressure and decrease in velocity as the subjects move from the upright through the supine to the upside down position and 2 the increase in pressure will be most evident in the mid-oesophagus at the transition zone between the striated and the smooth muscle contractions
Detailed Description:
Introduction High Resolution Manometry HRM is an advance in oesophageal measurement that permits the acquisition of pressure data through the entire length of the oesophagus over time via closely spaced sensors that continuously record the motor activity of the oesophagus This information can then be analysed either as conventional line plots or as a spatiotemporal plot a compact visually intuitive presentation of oesophageal pressure activity1 This process has been quantified and verified in 75 normal volunteers2 Increasing evidence suggests that HRM is a more sensitive and accurate means of assessing oesophageal function compared to conventional manometry1 3 Compared to conventional manometry HRM increases the accuracy with which the success of bolus transport can be predicted1 This is important because oesophageal symptoms are more closely linked to impaired bolus transport than conventional pressure measurements per se4
The additional information provided by HRM and the presentation of data as a spatiotemporal plot enable investigators to study the pressure activity in the oesophagus during normal eating behaviour for the first time This study will assess the effects of position bolus volume and consistency liquid solid In addition pressure activity during a standardized test meal will be observed
Understanding the oesophageal response due to these physiologic challenges is likely to be of clinical importance because most patients complain of swallowing problems regurgitation or chest pain during such events and in the postprandial period This is in contrast to standard manometry protocols that include the intake only of individual water viscous fluid eg yoghurt or small solid bolus swallows
Healthy controls will be studies to provide normal data Patients referred for investigation of oesophageal symptoms will be studied to assess whether physiologic challenge increases the ability to differentiate this group from normal controls explain patient symptoms and increase diagnostic yield
Effects of Position It is well known that transient lower oesophageal sphincter relaxations TLOSRs and reflux events are suppressed in the supine position in both healthy volunteers and in patients with mild-moderate reflux disease7 The effects of position on oesophageal peristalsis and lower oesophageal sphincter pressure assessed by conventional manometry have been less consistent
Recently HRM and video-fluoroscopy has been applied to study the effect of position and bolus consistency on oesophageal function8 No effect of position on LOS pressure was found in these thin healthy volunteers In contrast peristaltic pressure increased and velocity decreased as the subject moved from the upright to the supine position Similarly peristaltic pressure increased and velocity decreased progressively as the subject took dry water and solid swallows8 These observations confirm combined manometry and impedance studies that show oesophageal function is not stereotyped but responds to the workload required for bolus transport 5 67
Although findings are consistent for a given individual variation in peristaltic contractile pressure is high and the correlation between peristaltic pressure and the success of bolus transport in healthy volunteers and patients is weak Rather preliminary observations by Fox et al suggest that successful bolus transport especially for solids may depend more on effective coordination between proximal striated and mid-distal smooth muscle contractions than increased peristaltic pressure In particular the prompt response of the mid-oesophageal segment appears to be linked to successful bolus transport through the oesophagus8
Swallowed material can be transported successfully through the oesophagus in the upside down position With the use of HRM a detailed analysis of oesophageal peristalsis and bolus transport from the pharynx to the stomach is possible We propose to explore the effect of 3 different positions upright supine and 60o head down on the swallow of liquid and viscous material in healthy volunteers Use of the extreme head down position provides a classical physiologic challenge that will highlight the oesophageal response to increased work against gravity
Further events that increase oesophageal workload include the rapid intake of large volumes of fluid ie free drinking and the intake of solid food ie test meal Following the studies of position on oesophageal function we will then assess the effect of drinking a standardized fluid load by multiple repeated swallows and intake of a standardized test meal on oesophageal and lower oesophageal sphincter function Observations will be continued for 20minutes after ingestion to assess also oesophago-gastric function in the postprandial period
Study hypothesis The driving force developed by oesophageal motor function increases progressively with workload eg increasing inclination solid food in healthy volunteers
Hypothesis 1 This increase in driving force will be more apparent and consistent as an increased in coordination of peristaltic contractions and development of intra-bolus pressure ie endpoints assessed only by HRM than effects on contractile pressure ie endpoints assessed also by conventional manometry
Repeated swallowing during drinking suppresses oesophageal contractility Hypothesis 2 Intermittent coordinated and powerful peristaltic waves will be observed during a test meal and failure of this activity will result in raised intra-bolus pressure and symptoms dysphagia regurgitation chest pain
Hypothesis 3 Observations during and after a test meal will increase diagnostic yield for rumination and reflux related symptoms during stationary studies
The additional information provided by HRM and the presentation of data as a spatiotemporal plot enable investigators to study the pressure activity in the oesophagus during normal eating behaviour for the first time This study will assess the effects of position bolus volume and consistency liquid solid In addition pressure activity during a standardized test meal will be observed
Understanding the oesophageal response due to these physiologic challenges is likely to be of clinical importance because most patients complain of swallowing problems regurgitation or chest pain during such events and in the postprandial period This is in contrast to standard manometry protocols that include the intake only of individual water viscous fluid eg yoghurt or small solid bolus swallows
Healthy controls will be studies to provide normal data Patients referred for investigation of oesophageal symptoms will be studied to assess whether physiologic challenge increases the ability to differentiate this group from normal controls explain patient symptoms and increase diagnostic yield
Effects of Position It is well known that transient lower oesophageal sphincter relaxations TLOSRs and reflux events are suppressed in the supine position in both healthy volunteers and in patients with mild-moderate reflux disease7 The effects of position on oesophageal peristalsis and lower oesophageal sphincter pressure assessed by conventional manometry have been less consistent
Recently HRM and video-fluoroscopy has been applied to study the effect of position and bolus consistency on oesophageal function8 No effect of position on LOS pressure was found in these thin healthy volunteers In contrast peristaltic pressure increased and velocity decreased as the subject moved from the upright to the supine position Similarly peristaltic pressure increased and velocity decreased progressively as the subject took dry water and solid swallows8 These observations confirm combined manometry and impedance studies that show oesophageal function is not stereotyped but responds to the workload required for bolus transport 5 67
Although findings are consistent for a given individual variation in peristaltic contractile pressure is high and the correlation between peristaltic pressure and the success of bolus transport in healthy volunteers and patients is weak Rather preliminary observations by Fox et al suggest that successful bolus transport especially for solids may depend more on effective coordination between proximal striated and mid-distal smooth muscle contractions than increased peristaltic pressure In particular the prompt response of the mid-oesophageal segment appears to be linked to successful bolus transport through the oesophagus8
Swallowed material can be transported successfully through the oesophagus in the upside down position With the use of HRM a detailed analysis of oesophageal peristalsis and bolus transport from the pharynx to the stomach is possible We propose to explore the effect of 3 different positions upright supine and 60o head down on the swallow of liquid and viscous material in healthy volunteers Use of the extreme head down position provides a classical physiologic challenge that will highlight the oesophageal response to increased work against gravity
Further events that increase oesophageal workload include the rapid intake of large volumes of fluid ie free drinking and the intake of solid food ie test meal Following the studies of position on oesophageal function we will then assess the effect of drinking a standardized fluid load by multiple repeated swallows and intake of a standardized test meal on oesophageal and lower oesophageal sphincter function Observations will be continued for 20minutes after ingestion to assess also oesophago-gastric function in the postprandial period
Study hypothesis The driving force developed by oesophageal motor function increases progressively with workload eg increasing inclination solid food in healthy volunteers
Hypothesis 1 This increase in driving force will be more apparent and consistent as an increased in coordination of peristaltic contractions and development of intra-bolus pressure ie endpoints assessed only by HRM than effects on contractile pressure ie endpoints assessed also by conventional manometry
Repeated swallowing during drinking suppresses oesophageal contractility Hypothesis 2 Intermittent coordinated and powerful peristaltic waves will be observed during a test meal and failure of this activity will result in raised intra-bolus pressure and symptoms dysphagia regurgitation chest pain
Hypothesis 3 Observations during and after a test meal will increase diagnostic yield for rumination and reflux related symptoms during stationary studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None