Esophageal motility disorders and gastroesophageal reflux in ventilated critically ill patients with different feeding tolerance: effect of prokinetics

Esophageal dysmotility and gastroesophageal reflux in adult ventilated critically ill patients with low and high residual gastric volumes and how it is affected by intravenously administered metoclopramide: a controlled, single center, prospective study using high resolution impedance manometry

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14399966

Enrollment

Registered

2020-09-03

Start date

2013-01-23

Completion date

Unknown

Last updated

2023-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal dysmotility and gastroesophageal reflux in ventilated critically ill patients Digestive System

Interventions

Critically ill hemodynamically stable patients fulfilling inclusion/exclusion criteria within 24-48 hours after reaching the enteral nutrition target of 25 kcal/kg/day are assigned according to residu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Critically ill patients 1. Informed consent signed by a close relative and retrospectively by the patient when his/her condition allows it 2. Age of 18 years and above 3. Mechanically ventilated critically ill patient 4. Inclusion within 24-48 hours after reaching the enteral nutrition target of 25 kcal/kg/day 5. Maximum stable dose of noradrenaline up to 0.2 µg/kg/min 6. Enteral nutrition via nasogastric tube Control group 1. Signed informed consent 2. Age of 18 years and above

Exclusion criteria

Exclusion criteria: Critically ill patients: 1. History of previous surgery on upper gastrointestinal tract 2. Gastroesophageal reflux disease 3. Portal hypertension 4. Active gastrointestinal bleeding 5. When an acute diagnostic or treatment procedure outside the intensive care unit at the time of HRIM measurements is required 6. Epilepsy, severe CNS damage or other contraindication for metoclopramide administration 7. Coagulopathy with INR value above 2.5 and platelets below 30x10e9/L 8. Pregnancy Control group 1. History of previous surgery on upper gastrointestinal tract 2. Diagnosed gastroesophageal reflux disease or symptoms thereof, esophageal varices, or other organic esophageal or gastric disorder 3. Use of chronic medication, other acute or chronic illness 4. Pregnancy

Design outcomes

Primary

Measure	Time frame
1. To characterize esophageal dysfunction in critically ill patients in comparison to physiologic conditions and to verify whether the administration of a prokinetic is effective in improving esophageal dysfunction in critically ill patients using: 1.1. High-resolution manometry (HRM) resting parameters of critically ill patients: tone of lower esophageal sphincter (mmHg); presence of hiatal hernia; inspiratory esophago-gastric junction (EGJ) pressure (mmHg); average maximal inspiratory EGJ pressure for three respiratory cycles; expiratory EGJ pressure (mmHg); average EGJ pressure midway between inspirations for the same three respiratory cycles; and esophago-gastric junction contractile integral (EGJ-CI) (mmHg.cm) measured in 3 periods in each study hour (10.-15., 25.-35. and 45.-55. mins) so that the landmark window is placed ideally in a quiescent portion of recording, free of swallows between 0 and 6 h 1.2. HRM dynamic parameters in critically ill patients: number of panesophageal activities/h; distal contractile integral (mmHg.cm.s); % of failed peristalsis; % of panesophageal pressurization; % of premature contractions; % of double peaked waves; % of triple peaked waves; distal latency (s); contractile front velocity (cm/s); integrated relaxing time (mmHg); and intrabolus pressure (mmHg) measured from all panesophageal activities at 0, 1, 2, 3, 4, 5, and 6 h 1.3. Both static HRM variables of tone of lower esophageal sphincter (mmHg), EGJ inspiratory pressure (mmHg), EGJ expiratory pressure (mmHg), and EGJ-CI (mmHg.cm); and dynamic HRM variables: distal contractile integral (mmHg.cm.s), distal latency (s), contractile front velocity (cm/s), integrated relaxing time (mmHg), intrabolus pressure (mmHg); in control patients measured in the fasting, postprandial and intervention phases, expressed as median of all values in each phase 1.4 Impedance recording including: 1.4.1. The number o	—

Measure

Time frame

1. To characterize esophageal dysfunction in critically ill patients in comparison to physiologic conditions and to verify whether the administration of a prokinetic is effective in improving esophageal dysfunction in critically ill patients using: 1.1. High-resolution manometry (HRM) resting parameters of critically ill patients: tone of lower esophageal sphincter (mmHg); presence of hiatal hernia; inspiratory esophago-gastric junction (EGJ) pressure (mmHg); average maximal inspiratory EGJ pressure for three respiratory cycles; expiratory EGJ pressure (mmHg); average EGJ pressure midway between inspirations for the same three respiratory cycles; and esophago-gastric junction contractile integral (EGJ-CI) (mmHg.cm) measured in 3 periods in each study hour (10.-15., 25.-35. and 45.-55. mins) so that the landmark window is placed ideally in a quiescent portion of recording, free of swallows between 0 and 6 h 1.2. HRM dynamic parameters in critically ill patients: number of panesophageal activities/h; distal contractile integral (mmHg.cm.s); % of failed peristalsis; % of panesophageal pressurization; % of premature contractions; % of double peaked waves; % of triple peaked waves; distal latency (s); contractile front velocity (cm/s); integrated relaxing time (mmHg); and intrabolus pressure (mmHg) measured from all panesophageal activities at 0, 1, 2, 3, 4, 5, and 6 h 1.3. Both static HRM variables of tone of lower esophageal sphincter (mmHg), EGJ inspiratory pressure (mmHg), EGJ expiratory pressure (mmHg), and EGJ-CI (mmHg.cm); and dynamic HRM variables: distal contractile integral (mmHg.cm.s), distal latency (s), contractile front velocity (cm/s), integrated relaxing time (mmHg), intrabolus pressure (mmHg); in control patients measured in the fasting, postprandial and intervention phases, expressed as median of all values in each phase 1.4 Impedance recording including: 1.4.1. The number o

—

Secondary

Measure	Time frame
1. Feasibility and safety of performing HRIM in critically ill patients measured using the percentage of: cases of successful HRIM catheter insertion; and type of complications of insertion of HRIM catheter (such as epistaxis) 2. Statistical analysis measured using: 2.1. Data from the critically ill patients during the first 2 h of the study to analyze general features of esophageal motility functions in critically ill patients, and to compare the pattern of abnormal esophageal physiology and the occurrence of reflux in patients with LGV to HGV. When analyzing the data before and after metoclopramide administration in critically ill patients, data from the first 2 h of the study are evaluated against the following 3 h after metoclopramide. 2.2. Data from the control group during the fasting phase will be compared to the postprandial phase and data from the postprandial phase with the data from the intervention phase 2.3. HRM data between the control group and critically ill patients will also be compared	—

Measure

Time frame

1. Feasibility and safety of performing HRIM in critically ill patients measured using the percentage of: cases of successful HRIM catheter insertion; and type of complications of insertion of HRIM catheter (such as epistaxis) 2. Statistical analysis measured using: 2.1. Data from the critically ill patients during the first 2 h of the study to analyze general features of esophageal motility functions in critically ill patients, and to compare the pattern of abnormal esophageal physiology and the occurrence of reflux in patients with LGV to HGV. When analyzing the data before and after metoclopramide administration in critically ill patients, data from the first 2 h of the study are evaluated against the following 3 h after metoclopramide. 2.2. Data from the control group during the fasting phase will be compared to the postprandial phase and data from the postprandial phase with the data from the intervention phase 2.3. HRM data between the control group and critically ill patients will also be compared

—

Countries

Czech Republic

Contacts

Public ContactKarel Balihar

balihar@fnplzen.cz+42 0720375344

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 16, 2026