Detection of Gastric distension with use of an oxygen delivery device in patients of respiratory diseases

Not yet recruiting

Conditions: Bronchiectasis with acute lower respiratory infection, (2) ICD-10 Condition: J441||Chronic obstructive pulmonary disease with (acute) exacerbation, (3) ICD-10 Condition: J459||Other and unspecified asthma,

Registration Number: CTRI/2020/03/024398

Lead Sponsor: AIIMS Jodhpur

Brief Summary: HFNO is being increasingly used these days in patients with acute and chronic respiratory failure as a useful alternative to conventional oxygen therapy and other noninvasive systems of respiratory support. We expect gastric insufflation to be present as a complication in patients of obstructive high airway resistance diseases, who use HFNO and quantify the distension according to different flows. All patients who are diagnosed to have obstructive airway diseases and is on conventional oxygen therapy will be enrolled in the study. After giving detailed description about the study that is being conducted and obtaining informed consent, a brief history of the patients who are enrolled for the study will be taken regarding relevant comorbidities and duration of repiratory illness and medications. Physiological data including vital signs such as heart rate, respiratory rate, blood pressure, pulse oxygen saturation and ABG values which include PaO2, PaCO2, PaO2/FiO2, SaO2 is recorded.Once the decision of HFNO therapy is made by the treating clinician, patientâ€™s basal gastric volume is measured using ultrasonography.The average number of peristaltic contractions of stomach in one minute will be calculated after counting the epristaltic contractions for a time period of 5 minutes.

Following this, HFNO therapy will be started as per the Department protocol, initial flow will be set at 40L/min and increased by 5L/min increments as tolerated by the patient and depending on respiratory rate and distress. FiO2 will be titrated so as to attain an SPO2>92 for the patient. A 2nd and 3rd ultrasound scan will be done respectively at 10 and 30 min after start of HFNO therapy. These scans will look for airleaks into stomach and any change in gastric volume. The average number of peristaltic contractions of stomach in one minute will be calculated after counting the peristaltic contractions for a time period of 5 minutes. The new vitals and ABG values are recorded after 30 minutes of start of therapy.

Scans will be repeated at 10 min and 30 min whenever a change is made in the flow rates as part of HFNO therapy.

The total duration of HFNO therapy and its outcome will also be recorded

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Adult patients aged above 18 yrs Diagnosed case of any obstructive airway disease Tachypnoeic (RR>20) and in need of oxygen therapy( ie.SPO2<92) recognised by clinician.

Exclusion Criteria

Pregnant women Patients with severe respiratory failure requiring immediate tracheal intubation and mechanical ventilation SPO2>92% Obese patients and postoperative patients after upper abdominal surgery, where abdominal ultrasound could be difficult Patients on continuous rhyles tube aspiration Patients with any serious cardiovascular, renal or hepatic illnes Patients with abnormalities of face or who are post surgery of face, nose or airway that preclude an appropriate fitting nasal cannula Psychiatric, agitated or non-cooperative patients Patients with altered sensorium.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To observe the prevalence of gastric insufflation at different flow rates of HFNO in a range of 40-60L/min in obstructive airway disease patients.	30 min

Secondary Outcome Measures

Name	Time	Method
To observe the difference in gastric volume before and after application of HFNO in obstructive airway disease patients.	To detect the increase in peristaltic activity of gastric antrum,as a surrogate marker for gastric insufflation.

Trial Locations

Locations (1): AIIMS Jodhpur
🇮🇳
Jodhpur, RAJASTHAN, India
AIIMS Jodhpur
🇮🇳Jodhpur, RAJASTHAN, India
Dr Pradeep Bhatia
Principal investigator
bhatiapk@aiimsjodhpur.edu.in