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Clinical Trials/CTRI/2024/04/065366
CTRI/2024/04/065366
Not yet recruiting
Phase 2/3

Effect of completely occlusive nasal pack versus nasal pack with airway on eustachian tube function and arterial blood gas- a randomised controlled trial

Dr Hithyshree N1 site in 1 country62 target enrollmentStarted: April 17, 2024Last updated:

Overview

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Dr Hithyshree N
Enrollment
62
Locations
1
Primary Endpoint
Middle ear aeration and pulmonary ventilation

Overview

Brief Summary

Nasal packs are usually used in case of epistaxis and after nasal surgeries to control bleeding and to support and stabilize the bony and cartilaginous structures. Due to packing, patients experience significant discomfort in the post-operative period. Bilateral nasal packing can lead to compromised Eustachian tube function. Eustachian tube patency is very important to maintain middle ear pressure and its dysfunction can lead to Eustachian tube catarrh, secretory otitis media. Nasal obstruction can lead to hypoxia, sleep apnea especially in patients with vulnerable cardiac function or poor lung capacity. Mouth breathing can also lead to imbalance in the acid- base due to disturbance in pulmonary ventilation. Some patients may experience fall in saturation when in deep sleep.

In this study, the pulmonary side effects and alterations in Eustachian tube function associated with the use of nasal packs will be evaluated.

The effect of totally occlusive nasal pack and nasal pack with airways on pulmonary and Eustachian tube function will be compared.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • All patients aged between 18- 60 years planned for nasal surgeries and patients with epistaxis requiring bilateral anterior nasal packs.

Exclusion Criteria

  • Patients with mucociliary disorders
  • Patients requiring posterior nasal pack
  • Patients who have received radiation to nasopharynx or the surrounding areas
  • Very obese patients with history of obstructive sleep apnea
  • Patients with impaired cardiac functions.

Outcomes

Primary Outcomes

Middle ear aeration and pulmonary ventilation

Time Frame: At baseline & Day 1

Secondary Outcomes

  • Oxygen saturation(Post operative day 1)

Investigators

Sponsor
Dr Hithyshree N
Sponsor Class
Other [Post graduate resident]
Responsible Party
Principal Investigator
Principal Investigator

Dr Hithyshree. N

Sri Devaraj urs medical college

Study Sites (1)

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